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. 2020 Aug 27;15(8):e0237973. doi: 10.1371/journal.pone.0237973

Efficacy of adding activity of daily living simulation training to traditional pulmonary rehabilitation on dyspnea and health-related quality-of-life

Kayla Mahoney 1, Jacqueline Pierce 1, Stacey Papo 2, Hafiz Imran 1,3, Samuel Evans 2, Wen-Chih Wu 1,3,*
Editor: Vinicius Cavalheri4
PMCID: PMC7451521  PMID: 32853275

Abstract

Introduction

Exercise modalities offered as part of traditional pulmonary rehabilitation (PR) do not always translate to successful performance of Activities of Daily Living (ADL) and may hinder gains in patient’s sense of well-being. Data is lacking on the efficacy of incorporation of ADL-focused training in PR. The aim of this study was to determine the impact of incorporation of ADL simulation and energy-conservation training in PR as part of a quality-initiative on health-related-quality-of-life (HRQOL), dyspnea, fatigue, and six-minute-walk-test among PR patients.

Methods

Retrospective study where medical records of consecutive patients with chronic respiratory diseases who completed PR from 2016 to 2018 were reviewed. ADL-focused energy-conservation training was added to traditional PR in September 2017 by replacing three monthly sessions of traditional PR with energy-conservation training as a quality-improvement-initiative. The change from baseline on HRQOL measured by COPD assessment test (CAT), six-minute-walk-test, MMRC dyspnea score and CRQ-dyspnea and CRQ-fatigue questionnaires, were compared between patients who received traditional PR versus energy-conservation PR. Within and between group differences were calculated via repeated-measures ANOVA.

Results

The baseline characteristics of 91 patients who participated in traditional PR versus energy-conservation PR (n = 85) were similar (mean age = 68.6±10.4 years, 49% men). While improvement from baseline was similar and significant for both groups for MMRC, CRQ-dyspnea and CRQ-fatigue scores, and six-minute walk test, patients who participated in energy-conservation PR had significantly higher improvement in HRQOL CAT scores (p = 0.01) than those who completed traditional PR.

Conclusion

Tailoring patient’s training programs to include energy-conservation training exercises specific to ADL in PR improved HRQOL over traditional PR in patients with chronic respiratory diseases despite no significant change in functional status. Future randomized-controlled trials will be needed to confirm these initial findings.

Introduction

Pulmonary Rehabilitation (PR) is a multi-faceted intervention offered to patients with chronic respiratory diseases that includes patient tailored exercise programming and education aimed at promoting positive health behavioral changes for the self-management of disease [1–4]. Pulmonary rehabilitation has been demonstrated in patients with respiratory diseases of varying severity to improve exercise tolerance, health-related-quality-of-life (HRQOL), dyspnea and fatigue, utilization of medical therapies, reducing hospitalizations, and improving survival [1–5]. However, patients with respiratory diseases may still find difficulties in performing their activities of daily living (ADLs) which may attenuate the potential benefits achieved in their sense of well-being and/or functional status.

Evidence based clinical guidelines for exercise prescription have been published by two leading organizations including the American Thoracic Society and the American Association of Cardiovascular and Pulmonary Rehabilitation for improving dyspnea, functional capacity and HRQOL among patients with chronic obstructive pulmonary disease (COPD) [2, 3]. Both organizations agree that patients should participate in 4 to 12 weeks of supervised light to moderate intensity cardiovascular exercise 3 to 5 times per week for 20 to 60 minutes per session using walking and or cycling as primary exercise modalities. Guidelines for resistance training exercise have also been developed but lack specificity. While it is well understood that both upper and lower extremity resistance training exercises be included as part of a balanced exercise program in PR, data on tailored training specific to improving performance with ADLs, energy-conservation strategies and its effects on outcomes remain lacking in PR.

In addition to following the guidelines for exercise prescription, clinicians should also consider inclusion of energy-conservation techniques in all PR based on The American Association of Cardiovascular and Pulmonary Rehabilitation guidelines [3]. Energy conservation are techniques often used by occupational therapy focused on pacing, posture, and breathing to reduce the physical demand of common activities that individuals find challenging and or to meet occupational needs [6, 7]. These techniques include use of pursed lips breathing and avoidance of forward bending since they have been shown to reduce the dynamic hyperinflation experienced by COPD patients during performance of certain ADLs [7]. Learning and applying energy conservation techniques to reduce patients’ energy expenditure and dyspnea with ADL’s have the potential to improve functional performance and quality of life in COPD patients [7, 8].

Previous study on individualized occupational therapy focused on energy conservation did not improve occupational performance or satisfaction over usual care in patients with COPD [8], but formal PR was not part of the intervention. When PR was combined with the application of energy conservation techniques among patients with COPD, some investigators observed improvement in time to perform ADL tests, functional capacity, and self-reported Borg symptom ratings of dyspnea and fatigue [9]. However, a comprehensive assessment of the patient’s HRQOL as result of these changes has not been performed [10]. Moreover, the efficacy of energy conservation training as part of a comprehensive PR in non-COPD patients as well as its comparison with traditional PR without energy conservation training are both unknown. The aim of this retrospective study based on the implementation of a quality initiative was to investigate the change in HRQOL, fatigue, dyspnea, and six-minute walking distance before and after the incorporation of energy conservation in ADL training to traditional PR among patients with COPD and non-COPD chronic respiratory diseases enrolled in two PR programs.

Methods

Study design

The Miriam Hospital IRB approved this retrospective study under the title of "Patient characteristics, cardiac rehabilitation intervention and their relationship with cardiovascular outcomes", IRB# 637472, IRB Board #216514. The study has waiver of informed consent. The study was a retrospective, observational comparison of patients enrolled in PR before (October 2016 through August 2017) and after (September 2017 to September 2018) the addition of the new energy conservation in ADL simulation training to traditional PR intervention, as part of an institutional quality-improvement initiative in September of 2017.

Study sample

Medical records of 176 patients with qualifying diagnoses for PR of COPD, asthma, pulmonary fibrosis, interstitial lung disease, lung transplant, lung cancer, bronchiectasis, pulmonary hypertension, restrictive lung disease, and chronic respiratory failure who completed PR in either a University Teaching Hospital or a Community Hospital were reviewed. Patients were not eligible for PR enrollment if they had unstable cardiac disease, uncontrolled diabetes or hypertension, or significant cognitive impairment. For this study, we only reviewed the records of patients who completed the 12 weeks of the PR program since patients who did not complete PR did not have the post-PR questionnaires and assessments.

All patients who enrolled in PR irrespective of the study period, completed the COPD Assessment Tool (CAT) for HRQOL [11], Chronic Respiratory Questionnaire (CRQ-dyspnea) and Modified Medical Research Council Questionnaire (MMRC) [12] for the assessments of dyspnea, and Chronic Respiratory Questionnaire (CRQ-fatigue) [13] for evaluation of fatigue, at the PR enrollment visit and at discharge from the program.

Primary outcome

Our primary outcome was Health Related Quality of Life or HRQOL, as measured by CAT, since it encompassed a spectrum of domains that determined a patient’s holistic self-sense of well-being [10]. The CAT questionnaire is both a reliable and valid tool for evaluating HRQOL among patients with COPD and is recommended by the American Thoracic Society for evaluating the impact of COPD on health status [11]. The CAT assesses cough, sputum, dyspnea, chest tightness, and sleep with each item scaled between one to five. Scores range between zero and forty where higher scores reflect greater impact of COPD severity on HRQOL. The American Association of Cardiovascular and Pulmonary Rehabilitation guidelines indicate that a change in CAT score ≥2 in the negative direction as significant.

Secondary outcomes

The CRQ questionnaire is also approved as a reliable and valid measure of HRQOL among COPD patients evaluating four domains of disease including dyspnea, fatigue, emotional, and mastery [13]. This study collected data on the dyspnea and fatigue domains where ≥ 0.5 point improvement in individual scores has been determined as significant by the American Association of Cardiovascular and Pulmonary Rehabilitation. The CRQ dyspnea domain is particularly valuable as patients rate breathlessness on their five most important ADLs chosen from a list and is therefore unique to each individual [10]. The domain of fatigue was also considered since it is a common complaint of patients suffering from chronic respiratory illnesses [14].

The MMRC has been found to be a reliable and valid tool for the assessment of dyspnea and disability among the COPD patient population [12]. It is unique in our study population as it collects data on dyspnea with ADLs. Disease severity is graded zero to four where higher values correlate with greater dyspnea with ADLs.

Exercise tolerance

A six-minute walk test was performed both at baseline and discharge from PR to assess each patient’s functional capacity [15]. Testing conditions were the same for both tests regarding the use of assistive devices, oxygen titration, and method for carrying oxygen. Absolute and relative contraindications to exercise testing defined by the American Thoracic Society guidelines were reviewed prior to administration of each walk test and same protocols were followed for consistency [15].

Comparison groups

Pre-implementation: Traditional Pulmonary Rehabilitation group (Traditional PR)

Patients attended 12 weeks of twice weekly supervised standard PR that consisted of exercise sessions for 60 minutes in addition to a 30-minute education class on exercise, nutrition, psychosocial components, medications, anatomy and physiology as it relates to breathing and lung disease, and symptoms. Exercise consisted of a combination of both individualized aerobic (examples: treadmill, arm ergometer, stationary bicycle, and NuStep) and resistance training modalities (examples: Keiser machines, light hand weights and resistance bands). No energy conservation training in ADL simulation scenarios were provided.

Implementation: Energy Conservation Pulmonary Rehabilitation group (Energy Conservation PR)

The energy conservation PR consisted of same standard 12 weeks of twice weekly traditional PR exercise and education sessions, but one time per month (usually the second or third Tuesday of every month), energy conservation on ADL simulation training occurred in place of one traditional PR session. Session duration remained the same at 90 minutes and consisted of 60 minutes of targeted resistance training and energy conservation techniques focused on the performance of simulated ADLs, in addition to a 30-minute education session; hence equating the total exercise and education time from the traditional PR. Therefore, patients would have up to three separate occasions to receive energy conservation training throughout their 12-week program regardless of the timing of their enrollment as both facilities practice rolling enrollment. This energy conservation addition to the traditional PR program (i.e. energy conservation PR) resulted as part of an institutional quality-improvement initiative in September of 2017.

As part of the individualized energy conservation training, a baseline questionnaire (Self-Reported Task Difficulty, Fig 1) was administered prior to the exercise training. The Self-Reported Task Difficulty was extracted from a portion of the CAT and adopted to quantify the difficulty in performance of specific ADLs for training purposes. It is not yet validated amongst the non-COPD population. Patients rated difficulty of performance from zero (no difficulty) to five (extreme difficulty) on each individual ADL task including stairclimbing, bending, reaching, and vacuuming. These tasks were then used as targets for the energy conservation training in ADL simulation workstations.

Fig 1. Self-reported ADL task difficulty survey.

Fig 1

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The energy conservation on ADL simulation training began with 15 minutes of an instructor led warm up which included coaching on posture and pursed lip breathing in combination with 5 repetitions of 10 upper and lower extremity exercises specific to the selected ADL tasks that the individuals find difficult to perform. Patients began seated performing body weight side bending, overhead reaching, toe touching (dynamic hamstring stretch), and leg extensions. Patients then performed body weight standing exercises using a chair for stabilization including bilateral hip hinge, split stance hip hinge, high knee marching, hamstring curls, and sit to stand exercises. Following the warm-up exercises, patients rotated through 12 supervised ADL simulation stations tailored to include exercises specific to ADLs that the patients had rated as difficult, such as stair-climbing, vacuuming, reaching and bending tasks. Stair-climbing specific stations included a single stair step up and or climbing a single flight of stairs with a staff member. Vacuuming specific stations included a dumbbell front raise, Theraband® CLX one arm row, Theraband® CLX one arm shoulder extension, and weight shift with reach simulation. Stations specific to reaching included bodyweight or dumbbell shoulder press, door frame diagonal (low to high unilateral trunk rotation), chopping (high to low bilateral trunk rotation, and carrying grocery bags and unloading items into an upper level kitchen cabinet). Bending stations included a laundry basket deadlift, and removing pots and pans from a lower level kitchen cabinet. In the act of performing these simulated ADL tasks, patients were instructed on energy conservation techniques including pacing, posture, pursed lip breathing and occupational considerations, and were provided with adapted modifications for each ADL task when appropriate. In addition, patients received a detailed handout of the ADL exercises and were encouraged to practice the exercises at home to increase the benefit of the program [16]. Patients were held accountable to performing the handout exercises at home by self-report on each of their regularly scheduled PR exercise sessions. The 30-minute education class focused on providing patients with energy conservation strategies aimed at reducing the physical demand of common household activities including review on pacing, posture, and pursed lips breathing in addition to use of assistive devices, planning, prioritizing, and recruiting help from others when appropriate.

Statistical analysis

Continuous variables are expressed as mean ± standard deviation (SD), and categorical variables in percentages (%). The differences in baseline characteristics between the patients who dropped-out versus those who completed PR, and between traditional PR and energy conservation PR groups were compared using T-tests for continuous and chi2 for categorical variables. Change from baseline within the group and between the groups in primary and secondary outcomes were compared using repeated-measures ANOVA and Cohen’s d was calculated for between group comparisons for each outcome. Given that PR encompassed a heterogeneous group of patients, to assess whether study findings vary by COPD status, we tested for multiplicative interaction between type of PR and COPD diagnosis using linear regression where the dependent variable was change from baseline for each of the study outcomes. In addition, exploratory analyses were conducted within the energy conservation PR group on the change over time in the patient self-rating of ADL task difficulty. Analyses was performed only on the available data without imputation of missing data. Statistical analysis was performed using statistical software (STATA SE version15.0). A two-sided P value of ≤0.05 is considered significant.

Results

Out of the 142 patients enrolled between October 2016 and August 2017 (pre-implementation period), 51 (35.9%) patients did not complete the program. These patients were similar in age, gender and proportion of COPD diagnosis to the patients who completed the program (S1 Table). Out of the 138 patients enrolled between September 2017 and September 2018 (implementation of the energy conservation PR), 53 (38.4%) patients did not complete the program. Patients who dropped-out were on average 4 years younger but otherwise similar in gender and proportion of COPD diagnosis to the patients who completed the program (S1 Table). For both pre- and implementation periods, the top three reasons for dropped-out included medical event that precluded continued participation, non-compliance, and personal reasons.

Medical records of 176 patients (age 68.6 ± 10.4 years, FEV1 = 57.8 ± 26.3% predicted, FEV1/FVC = 0.6 ± 0.2%, 49% male) who completed the 12-week PR program were reviewed and analyzed. There were no significant differences in baseline characteristics between the Energy Conservation–PR (n = 85, 69% COPD and 31% non-COPD) and Traditional PR (n = 91, 59% COPD and 41% non-COPD) groups in age, gender, pulmonary function, functional status and pulmonary disease diagnoses (Table 1).

Table 1. Baseline characteristics.

Characteristics Energy Conservation PR (n = 85) Traditional PR (n = 90) p-value
Caucasian (%) 93 88 0.26
Men (%) 49.4 47.8 0.83
Age, years (mean ± SD) 70.0 ± 10.7 67.2 ± 9.9 0.08
FEV1, % predicted (mean ± SD)* 56.8 ± 27.7 58.8 ± 25.0 0.62
FEV1/FVC, % (mean ± SD)* 0.6 ± 0.2 0.6 ± 0.2 0.39
BMI, kg/m2 (mean ± SD)* 29.3 ± 6.1 30.7 ± 7.2 0.16
Diagnosis (%)
COPD 59 54 0.42
Asthma 5 8 0.63
Pulmonary Fibrosis 5 8 0.63
Interstitial Lung Disease 11 10 0.88
Bronchiectasis 5 2 0.36
Lung Cancer 4 3 0.93
Pulmonary Hypertension 11 10 0.88
Lung Transplant 0 2 0.17
Cystic Fibrosis 0 1 0.33
Restrictive Lung Disease 0 1 0.33
Chronic Respiratory Failure 0 1 0.33
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Abbreviations: PR = Pulmonary Rehabilitation, TPR = Traditional Pulmonary Rehab, FEV = Forced Expiratory Volume, FVC = Forced Vital Capacity, BMI = Body Mass Index, 6MWT = Six-Minute Walk Test.

*Sample size Energy Conservation/Traditional PR groups: FEV1: n = 80/86; FEV1/FVC: n = 78/86; BMI: 85/89.

Results after the energy conservation PR and traditional PR interventions are summarized in Table 2. Baseline values of the questionnaires between energy conservation and traditional PR were similar (all P values >0.05). When compared to baseline, both groups demonstrated significant and similar improvements in the dyspnea score as measured by MMRC and CRQ-dyspnea scores, perception of fatigue (CRQ-Fatigue), and functional status assessed by the six-minute-walk test (all P values <0.01). For HRQOL as assessed by the CAT score, only patients in the energy conservation, but not the traditional PR group, had significant improvements from baseline (P <0.01), and it was of greater magnitude compared to the traditional PR group (P = 0.01 between groups). Subgroup analysis by COPD status was described in S2 Table. The change from baseline in CAT scores was significantly greater for the energy conservation versus traditional PR in the COPD group (p = 0.03) and trended towards significance in the non-COPD group (p = 0.06). The change from baseline in the remaining outcomes (CRQ-dyspnea, CRQ-Fatigue, MMRC, six-minute-walk test) was similar between the energy conservation and the traditional PR groups in both the COPD and non-COPD patients. Regression analyses using multiplicative interaction did not show any of the above results to significantly differ by COPD status (all P values >0.25).

Table 2. Comparison between energy conservation and traditional pulmonary rehabilitation on patient outcomes.

Energy Conservation PR (mean ± SD) Traditional PR (mean ± SD) Cohen’s delta on the difference in change from baseline between Energy Conservation vs. Traditional PR (95% CI) P-value On Change Between Groups by ANOVA
n Before PR After PR n Before PR After PR
CAT 84 18.49 ± 7.17 14.75 ± 7.19 90 17.38 ± 6.79 16.76 ± 7.50* -0.43 (-0.74 to -0.14) 0.004
CRQ Dyspnea 84 15.93 ± 4.77 20.67 ± 6.06 90 14.90 ± 5.34 18.04 ± 6.51 0.23 (-0.06 to 0.53) 0.12
CRQ Fatigue 84 15.33 ± 4.72 18.27 ± 4.64 90 14.77 ± 4.08 17.10 ± 4.05 0.13 (-0.17 to 0.43) 0.38
MMRC 85 1.93 ± 0.99 1.33 ± 0.88 90 1.80 ± 0.90 1.49 ± 1.00 0.22 (-0.08 to 0.52) 0.10
6MWT 80 315.69 ± 114.73 363.62 ± 118.74 87 349.37 ± 108.72 407.13 -0.11 (-0.41 to 0.20) 0.49
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Baseline values of the questionnaires between Energy conservation and Traditional PR were similar (all P values >0.05).

*All P values <0.01 for change before vs. after for both Energy Conservation and Traditional PR, except for CAT in Traditional PR, where p = 0.38.

Cohen’s d: Positive value favors Energy conservation and Negative value favors Traditional PR.

Abbreviations: PR = Pulmonary Rehabilitation, CAT = COPD Assessment Tool, CRQ = Chronic Respiratory Questionnaire, MMRC = Modified Medical Research Counsel, 6MWT = Six Minute Walk Test.

Table 3 summarized the exploratory analyses of the change in self-reported ADL task difficulty amongst patients that participated in energy conservation PR and answered the questionnaires during the sessions. Only 53% (45/85) answered in session 2 and 20% (17/85) answered in all three sessions. Although improvement in ADL task difficulty were noted throughout the sessions, statistically significant changes were only observed for stair climbing (p = 0.04). Regression analyses did not show changes in ADL difficulty between sessions to significantly differ by COPD status (all p values >0.16).

Table 3. Change in self-reported difficulty of activities of daily living in energy conservation–pulmonary rehabilitation.

(mean ± SD) Energy Conservation PR (Session 1, n = 85) Energy Conservation PR (Session 2, n = 45*) Energy Conservation PR (Session 3, n = 17*) P-value on Change from Baseline by Repeated Measures ANOVA
Stair climbing 2.99 ± 1.17 2.58 ± 1.50 2.23 ± 1.44 0.04
Reaching 2.38 ± 1.39 1.87 ± 1.41 1.29 ± 1.16 0.18
Bending 2.25 ± 1.34 1.60 ± 1. 27 1.94 ± 1. 25 0.19
Vacuuming 2.38 ± 1.65 1.87 ± 1.66 1.76 ± 1.64 0.46
Total Score 9.99 ± 4.33 8.13 ± 5.12 7.23 ± 4.41 0.15
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Abbreviations: PR = Pulmonary Rehabilitation.

*Many patients who attended the sessions chose not to complete the follow-up surveys.

Discussion

To our knowledge, our study is the first to investigate the efficacy of adding ADL simulation exercises specific to problematic ADLs within a multidisciplinary PR program. This type of training has only been studied as an isolated form of occupational therapy as an alternative to patients with COPD who did not enroll in PR. Martinsen et al. implemented individualized exercise programs with goal directed resistance training specific to domestic problems identified by the Canadian Occupational Performance Measure hoping to improve outcomes of functional independence. These tailored resistance training exercise protocols were designed to replicate ADLs that patients reported to be difficult which included stair-climbing, walking uphill, vacuuming, making the bed, carrying groceries, and personal care tasks. They concluded that tailored resistance training targeted toward improving ADL ability was just as effective as generic resistance training exercise prescribed as part of traditional PR [8].

Only one study to date has combined occupational therapy sessions that applied energy conservation techniques with traditional PR. Vaes et al. administered once weekly occupational therapy sessions with a traditional exercise program which included both generic resistance training limited to machines, high intensity interval training on an arm cycle ergometer and treadmill walking among patients with COPD diagnosis [9]. The primary outcomes of this study focused on changes in oxygen uptake during the performance of ADL testing before and after completion of PR among other functional outcomes. However, they did not address overall program outcomes of dyspnea or HRQOL. They concluded that patients performed the ADL testing in less time, with less metabolic load, and with fewer symptoms of fatigue and dyspnea during testing. While the improvements in ADL testing translated to improved performance of ADLs, their resistance exercise program was not specifically tailored to address problematic tasks. Inclusion of tailored resistance training, application of energy conservation, and ADL simulation training in combination with traditional PR has not been done in the past. We found that incorporation of ADL simulation training into traditional PR is superior to traditional PR in significantly improving patient’s HRQOL measured by CAT score despite the lack of a significant difference in six-minute walk test. We hypothesize that ADL simulation can significantly impact patient-perceived outcomes of HRQOL due to its targeted training effects on performance of difficult ADL’s such as stair-climbing without change in objective measures of functional status. Further studies are needed to formally test these assumptions and find strategies to efficiently improve both HRQOL and functional status in PR without adding extra duration of PR sessions.

Despite the improvements seen in HRQOL, between group differences in dyspnea and fatigue scores as well as six-minute walk test were not observed. It is possible that higher dose or duration of the ADL intervention is needed to effect change in these metrics. For example, there is a large difference in the energy requirement of the tasks in the MMRC in order to advance from one category to the next. It is also likely that the muscular groups trained during ADL simulation did not significantly change the walking distance. In addition, while patients were encouraged to practice resistance training specific to ADLs at home, it is likely that the compliance to these difficult exercises is low without on-site supervision.

While generic resistance training guidelines from the American Thoracic Society and the American Association of Cardiovascular and Pulmonary Rehabilitation have been established, they lack guidance for implementing functional training specific to improving ADL task performance. The American Thoracic Society recommends two to three days per week of moderate intensity resistance training using repetitive lifting of relatively heavy loads as the primary modality. The American Association of Cardiovascular and Pulmonary Rehabilitation lacks specific resistance training guidelines but suggest the use of hand and ankle weights, free weights, machine weights, elastic resistance bands, and bodyweight exercises including stair-climbing and squats using lighter loads with higher repetitions to promote the development of muscular endurance [4]. Both organizations are in agreement that the inclusion of upper extremity resistance training is warranted, however, only the American Association of Cardiovascular and Pulmonary Rehabilitation provides direction that the upper limb activities selected be specific to tasks required for functional living [4]. Provided that there remains a gap in how specific resistance training exercise should be implemented for improvement in functional ADLs, the present study may provide the first evidence that investing in the inclusion of ADL training in PR sessions may improve HRQOL without sacrificing walking distance or dyspnea and fatigue scores.

Our study also has limitations. Given the retrospective design of this study, the possibility of change in temporal trends as potential bias as well as other unmeasured confounding factors that provide alternative explanation of our findings cannot be excluded. For example, we did not have data on home adherence to resistance training or to exercise prescription overall which could have partially explained the observed differences between the groups. In addition, since about one third of the patients did not complete PR in our program, our results are applicable only to patients who were able to complete PR. Future randomized-controlled trials that rigorously evaluate the Energy Conservation PR against Traditional PR to confirm our findings are required.

Conclusion

Our results indicate that when replacing three monthly sessions of traditional PR with energy conservation and ADL simulation training improved HRQOL outcomes over traditional PR alone. Tailoring patient’s individualized resistance training programs to include exercises specific to ADLs that the patient finds to be most difficult and training on energy conservation techniques while performing these tasks may help in these patients’ HRQOL outcomes.

Supporting information

S1 Table. Comparison of patients who completed the pulmonary rehabilitation versus drop-out.

(DOCX)

Click here for additional data file. (24.6KB, docx)
S2 Table. Comparison of the change from baseline in patient outcomes between energy conservation vs. traditional pulmonary rehabilitation by COPD status.

(DOCX)

Click here for additional data file. (26.9KB, docx)

Data Availability

Data cannot be shared publicly because of HIPAA regulations. A de-identified copy of the Data are available from the Miriam Hospital Institutional Ethics Committee (contact via email to Adrienne McParlin: amcparlin@lifespan.org) for researchers who meet the criteria for access to confidential data.

Funding Statement

The author(s) received no specific funding for this work.

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Decision Letter 0

Vinicius Cavalheri

12 May 2020

PONE-D-20-05739

Efficacy of Adding Activity of Daily Living Simulation Training to Traditional Pulmonary Rehabilitation on Dyspnea and Health-Related Quality-of-life

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Vinicius Cavalheri, Ph.D.

Academic Editor

PLOS ONE

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Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: No

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

**********

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

**********

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**********

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Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The manuscript called “Efficacy of Adding Activity of Daily Living Simulation Training to Traditional Pulmonary Rehabilitation on Dyspnea and Health-Related Quality-of-life” is very interesting and relevant to Pulmonary Rehabilitation area, but there are some considerations to do. It is reported below.

Abstract: clear.

Introduction: The authors explain the traditional pulmonary rehabilitation, justify the ADLs training needs but do not mention the energy conservation.

What is energy conservation?

Why energy conservation is important in this context?

I’m asking it because “The aim of this study was to determine the impact of incorporation of ADL simulation and energy conservation practice in PR as part of a quality-initiative on dyspnea, fatigue, and health-related-quality-of-life (HRQOL) among PR patients.”

Methods:

The authors must define the acronyms used to describe the groups in the methods and, after that, they can use that on the tables.

The description of ADL simulation and PR Groups is not clear.

Do the baseline questionnaire (Self-Reported Task Difficulty) is validated instrument?

The authors said “Therefore, in addition to the standard 12 weeks of twice weekly Traditional PR exercise and education sessions, ADL simulation intervention occurred in place of one regular Traditional PR session on a monthly basis for three months.”

Was there a specific time to start the ADL simulation training? (example: 2 weeks after started the PR or every 2 weeks in each month)

The Table 2 is not necessary, it could be described as part of the protocol, explaining the exercises. If the authors want to keep the table 2, they have to review the title (Table 2. Exercises Included in Energy Conservation Intervention) Where the Energy conservations are there?

When and how the energy conservation was used?

Results:

How many records was assessed?

How many was excluded and why?

Table 1 the result of 6MWT distance is showed in ft. The usual way to report this measure is in meters.

Why is not showed the p value for FEV1 and FEV1/FVC?

Table 3 the authors need to review the CRQF’s data the difference between EC and TPR groups is too big.

Table 4 - Although the p value was significant for Stairclimbing and Reaching, the standard deviations are very large, I recommend reviewing the statistic.

The authors should explain at the end of each table the definition of all the acronyms used.

Discussion:

There are papers published about the results of PR on ADLs and about energy conservation could help the authors discuss their results strongly.

Reviewer #2: This retrospective and observational study aimed to investigate the efficacy of a traditional PR added by an ADL simulation protocol on outcomes such as dyspnea, HRQOL and six-minute walk distance in subjects with chronic respiratory diseases. This is an interesting proposal since this topic of adding ADL simulation exercises to problematic ADLs in a PR program is innovative and it can contribute to the clinical practice. The manuscript is well written and the methodology is well organized. However, there are minor comments and some suggestions in order to improve the quality of the study.

Comments:

- This study reviewed medical records of a miscellaneous of respiratory diseases. In the authors’ opinion , may this study profile interfere in the results? How was the outcome differences of COPD and non-COPD subjects? Maybe this issue could be clearer in the article.

- The tables in the article need to be self-explanatory. Hence, the authors should describe the definition of each abbreviation in the tables 1, 3 and 4.

- The differences found on CAT and CRQ dyspnea are statistically significant, however, are they clinically relevant?

- The baseline values of the six-minute walk distance are mismatched in table 1 and 3. These values should be revised.

- Table 1 shows the baseline characteristics of the subjects between groups as well as the differences of those characteristics. There was any difference in the baseline scores of questionnaires of HRQOL? Maybe this information should be added in this table.

- Along the text of the manuscript the table 2 is mentioned prior to table 1. Maybe this citation need to be revised.

Reviewer #3: The study of Mahoney and colleagues investigated the addition of an ADL simulation protocol to PR on clinical outcomes in a variety of pulmonary diseases. The study was done collecting data retrospectively from an outpatient clinic. It is not clear, though, whether the data is from previous investigations or whether this is a real-life scenario. Authors conclude that the protocol provided additional benefits on quality of life and dyspnea. This is not, however, supported by the statistical treatment. Additionally, the temporal bias of the data collection was never mentioned in the manuscript. Specific comments are provided below.

Page 4. The heterogeneity of the sample is worrisome. Patients with different ILD respond different to treatment and they all differ from COPD. It is difficult to know whether the training responses observed (or the lack thereof) are due to the protocol or due to the large variety of diseases. I recommend choosing only one disease (e.g. COPD) to be reported.

Page 4. “ For this study, we only reviewed the records of patients who completed the 12 weeks of the PR program, which was 62% in 2017 and 58% in 2018.” Despite the retrospective design, it is a major limitation not having the data of attrition. If available, please include baseline characteristics of all patients (including dropouts) and describe reasons for non-completion of the protocol.

Page 5. As per definition, primary outcome is only one. Authors report three (MMRC, CRQ and CAT).

Page 7. “… between group differences in primary and secondary outcomes were compared using paired-sample and two-sample T tests respectively.” What exactly was compared between groups? Changes (Δ) or the assessments at week 12? A 2-way ANOVA seems more appropriate. The magnitude of differences (e.g. Cohen´s d test) is needed. Finally, it is recommended to report whether observed differences in changes are clinically relevant (i.e. exceeding MIDs of the tests).

Page 9. “We found that incorporation of ADL simulation training into Traditional PR is superior to Traditional PR in significantly improving patient’s HRQOL measured by CAT score and CRQ Dyspnea score despite the lack of a significant difference in six-minute walk test.” This is not (yet) a conclusion of your study. Authors found significant differences in the ADL group. This, however, does not necessarily means there is superiority as statistical treatment is inadequate.

Page 10. “ In addition, while patients were encouraged to practice resistance training specific to ADLs at home, it is likely that the compliance to these difficult exercises is low without on-site supervision.”. This remains controversial in the literature. Have you controlled it?

**********

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PLoS One. 2020 Aug 27;15(8):e0237973. doi: 10.1371/journal.pone.0237973.r002

Author response to Decision Letter 0

14 Jul 2020

July 12, 2010

PONE-D-20-05739

Efficacy of Adding Activity of Daily Living Simulation Training to Traditional Pulmonary Rehabilitation on Dyspnea and Health-Related Quality-of-life

PLOS ONE

Dear Editor and Reviewers,

Thank you for the opportunity to allow us to improve the manuscript. A draft with track changes in the manuscript was also submitted along with a clean version. Please see below an item to item response to the reviewer’s comments in red.

Reviewer #1: The manuscript called “Efficacy of Adding Activity of Daily Living Simulation Training to Traditional Pulmonary Rehabilitation on Dyspnea and Health-Related Quality-of-life” is very interesting and relevant to Pulmonary Rehabilitation area, but there are some considerations to do. It is reported below.

Abstract: clear.

Introduction: The authors explain the traditional pulmonary rehabilitation, justify the ADLs training needs but do not mention the energy conservation.

1. What is energy conservation? Why energy conservation is important in this context?

I’m asking it because “The aim of this study was to determine the impact of incorporation of ADL simulation and energy conservation practice in PR as part of a quality-initiative on dyspnea, fatigue, and health-related-quality-of-life (HRQOL) among PR patients.”

Energy conservation and its importance is now defined in the introduction and AACVPR guidelines for the inclusion of this technique in all PR programs is now referenced (p.3 last paragraph, p.4 first 2 paragraphs).

Methods:

2. The authors must define the acronyms used to describe the groups in the methods and, after that, they can use that on the tables.

Acronyms are now defined in methods in the subtitle of “Comparison Groups” and tables. We now minimized the use of acronyms to improve readability. We now used “Traditional Pulmonary Rehabilitation (Traditional PR)” for one group and “Energy Conservation Pulmonary Rehabilitation (Energy Conservation PR)” for the other group.

3. The description of ADL simulation and PR Groups is not clear.

We reorganized the methods section for clarity and added further details to the description of Energy conservation in ADL simulation and the distinction of both PR groups (p. 7 last paragraph, pp. 8-9).

4. Do the baseline questionnaire (Self-Reported Task Difficulty) is validated instrument?

The Self-Reported Task Difficulty questionnaire was adopted from a portion of the CAT and is not yet validated amongst the non-COPD population. This is now clarified in the methods section of the manuscript (p.8, last paragraph).

5. The authors said “Therefore, in addition to the standard 12 weeks of twice weekly Traditional PR exercise and education sessions, ADL simulation intervention occurred in place of one regular Traditional PR session on a monthly basis for three months.”

Was there a specific time to start the ADL simulation training? (example: 2 weeks after started the PR or every 2 weeks in each month)

There was no restriction on when patients can start their ADL simulation training in Pulmonary Rehab. The Pulmonary rehab program offered ADL simulation intervention in place of a regularly scheduled Traditional Pulmonary Rehab session on the second or third Tuesday of every month over the course of the year (Sept 2017-Sept 2018). Thus, patients would have up to three separate occasions to receive energy conservation on ADL simulation training during their 12-week session. This is now clarified in the methods section (p.8, second paragraph).

6. The Table 2 is not necessary, it could be described as part of the protocol, explaining the exercises. If the authors want to keep the table 2, they have to review the title (Table 2. Exercises Included in Energy Conservation Intervention) Where the Energy conservations are there?

When and how the energy conservation was used?

Table 2 has been removed and exercises have been described in detail in the methods section (pp. 8-9). In addition, we added further details in the paragraph of when and how the energy conservation was used.

Results:

7. How many records was assessed?

Medical records of 176 patients who completed the 12-week PR program were reviewed in the study and analyzed. This was clarified in the first sentence of the results section (p.11).

8. How many was excluded and why?

Patients who did not complete the PR program were excluded since we would not have post-PR questionnaires and assessments for comparison. We have provided the number of patients that were enrolled in the program for each group, in addition to the # of patients that dropped out. We have also included the top 3 reasons for drop out (p. 5, last paragraph).

9. Table 1 the result of 6MWT distance is showed in ft. The usual way to report this measure is in meters.

Converted feet to meters in Table 1.

10. Why is not showed the p value for FEV1 and FEV1/FVC?

We apologize for the typo, P values for FEV1 and FEV1/FVC have now been added

11. Table 3 the authors need to review the CRQF’s data the difference between EC and TPR groups is too big.

We apologize for the typo, the values for CRQF for Energy Conservation PR, pre and post, have been revised.

12. Table 4 - Although the p value was significant for Stairclimbing and Reaching, the standard deviations are very large, I recommend reviewing the statistic.

We thank the reviewer for the astute observation. We apologize for the typo. Per reviewer 3’s suggestion, we have now changed this to an exploratory analysis given significant missing and non-validated questionnaire, reported the available data on all three visits, and used repeated measures ANOVA for analysis. Only Stair climbing remained significant. The old Table 4, is now new Table 3.

13. The authors should explain at the end of each table the definition of all the acronyms used.

Thank you for the excellent suggestion. We have added the full wording of the acronyms as a footnote on each table.

Discussion:

14. There are papers published about the results of PR on ADLs and about energy conservation could help the authors discuss their results strongly.

Given the novelty of the idea in pulmonary rehab, there is a paucity of data in the topic. However, we have included now 4 papers in the topic including a paper published in 2019 on incorporation of energy conservation techniques in pulmonary rehab and its effect on functional performance measured by six-minute walk test and ADL task testing in the discussion (p.12, last paragraph, p.13, first paragraph).

Reviewer #2: This retrospective and observational study aimed to investigate the efficacy of a traditional PR added by an ADL simulation protocol on outcomes such as dyspnea, HRQOL and six-minute walk distance in subjects with chronic respiratory diseases. This is an interesting proposal since this topic of adding ADL simulation exercises to problematic ADLs in a PR program is innovative and it can contribute to the clinical practice. The manuscript is well written and the methodology is well organized. However, there are minor comments and some suggestions in order to improve the quality of the study.

Comments:

15. This study reviewed medical records of a miscellaneous of respiratory diseases. In the authors’ opinion, may this study profile interfere in the results? How was the outcome differences of COPD and non-COPD subjects? Maybe this issue could be clearer in the article.

We thank the reviewer for the excellent suggestion. We added a test for multiplicative interaction between type of PR and COPD diagnosis using linear regression to assess whether study findings varied by COPD status (p. 10, second paragraph). Results were summarized in the results section (last 2 paragraphs p.11 and first paragraph p.12).

16. The tables in the article need to be self-explanatory. Hence, the authors should describe the definition of each abbreviation in the tables 1, 3 and 4.

Footnote has been added on each table to describe the abbreviations

17. The differences found on CAT and CRQ dyspnea are statistically significant, however, are they clinically relevant?

We have added in the methods section the point change after which CAT and CRQ dyspnea scores are considered significant. Based on the recommendations by the American Association of Cardiovascular and Pulmonary Rehabilitation guidelines, a change ≥2 points in the negative direction on the CAT indicates less impact of COPD severity on a patients HRQOL (p.6, second paragraph). Improvement in CRQ-D scores ≥ 0.5 point are considered clinically relevant based on American Association of Cardiovascular and Pulmonary Rehabilitation guidelines (p.6, third paragraph, p.7 first paragraph).

18. The baseline values of the six-minute walk distance are mismatched in table 1 and 3. These values should be revised.

We apologize for the error, change has been made and reflects distance in meters instead of feet. Tables are now consistent pre and post.

19. Table 1 shows the baseline characteristics of the subjects between groups as well as the differences of those characteristics. There was any difference in the baseline scores of questionnaires of HRQOL? Maybe this information should be added in this table.

Baseline values of the questionnaires between Energy conservation and Traditional PR were similar (all P values >0.05). This is addressed in the results section (p.11, second paragraph) and footnote in new Table 2.

20. Along the text of the manuscript the table 2 is mentioned prior to table 1. Maybe this citation need to be revised.

This has been revised. Table 1 mentioned prior to the new Table 2 in the results section.

Reviewer #3: The study of Mahoney and colleagues investigated the addition of an ADL simulation protocol to PR on clinical outcomes in a variety of pulmonary diseases. The study was done collecting data retrospectively from an outpatient clinic.

21. It is not clear, though, whether the data is from previous investigations or whether this is a real-life scenario.

This is data collected from a real-life scenario. To clarify further, we modified the following sentence under study design (p. 5, first paragraph): “The study was a retrospective, observational comparison of patients enrolled in PR before (October 2016 through August 2017) and after (September 2017 to September 2018) the addition of the new energy conservation in ADL simulation training to Traditional PR intervention, as part of an institutional quality-improvement initiative in September of 2017”. In addition, in methods under study sample we stated (p. 5, second paragraph): “Medical records of 176 patients with qualifying diagnoses for PR … who completed PR in either a University Teaching Hospital or a Community Hospital were reviewed.”

22. Authors conclude that the protocol provided additional benefits on quality of life and dyspnea. This is not, however, supported by the statistical treatment. Additionally, the temporal bias of the data collection was never mentioned in the manuscript. Specific comments are provided below.

We have made modifications in the statistical methods using repeated measures ANOVA as suggested (p. 10, second paragraph) and added in the limitation section of the discussion “Given the retrospective design of this study, the possibility of change in temporal trends as potential bias as well as other unmeasured confounding factors that provide alternative explanation of our findings cannot be excluded” (p. 14, second paragraph).

23. Page 4. The heterogeneity of the sample is worrisome. Patients with different ILD respond different to treatment and they all differ from COPD. It is difficult to know whether the training responses observed (or the lack thereof) are due to the protocol or due to the large variety of diseases. I recommend choosing only one disease (e.g. COPD) to be reported.

To address this excellent point and per the suggestion of reviewer 1, we made the following modifications in statistical analysis (p.10, second paragraph): “Given that PR encompassed a heterogeneous group of patients, to assess whether study findings vary by COPD status, we tested for multiplicative interaction between type of PR and COPD diagnosis using linear regression where the dependent variable was change from baseline for each of the study outcomes.” Results were summarized in the results section (p.11, second paragraph): “Regression analyses using multiplicative interaction did not show any of the above results to significantly differed by COPD status (all p values >0.25)”.

24. Page 4. “For this study, we only reviewed the records of patients who completed the 12 weeks of the PR program, which was 62% in 2017 and 58% in 2018.” Despite the retrospective design, it is a major limitation not having the data of attrition. If available, please include baseline characteristics of all patients (including dropouts) and describe reasons for non-completion of the protocol.

We reviewed and compared baseline characteristics (age, gender and COPD diagnosis) of the patients who completed the program versus those who did not and summarized them in a new Supplemental Table and described them in methods (p.5, last paragraph). We also described the top three reasons for non-completion amongst the dropped-out population in the same paragraph.

25. Page 5. As per definition, primary outcome is only one. Authors report three (MMRC, CRQ and CAT).

We reorganized the text in the methods section to reflect that the primary outcome of the study is HRQOL, as measured by CAT, since it encompassed a spectrum of domains that determined a patient’s holistic self-sense of well-being and endorsed by both American Thoracic Society and the American Association of Cardiovascular and Pulmonary Rehabilitation (p.6, second paragraph).

26. Page 7. “… between group differences in primary and secondary outcomes were compared using paired-sample and two-sample T tests respectively.” What exactly was compared between groups? Changes (Δ) or the assessments at week 12? A 2-way ANOVA seems more appropriate. The magnitude of differences (e.g. Cohen´s d test) is needed.

We apologize for lack of clarity. Per the reviewer’s suggestions we have now compared the change from baseline within the group and between the groups in primary and secondary outcomes using repeated measures ANOVA and calculated the Cohen’s d for the between group differences for each study outcome (p. 9, second to last sentence).

27. Finally, it is recommended to report whether observed differences in changes are clinically relevant (i.e. exceeding MIDs of the tests).

We have added in the methods section the point change after which CAT and CRQ scores (dyspnea and fatigue) were considered clinically significant. Based on the recommendations by the American Association of Cardiovascular and Pulmonary Rehabilitation, a change of ≥2 points in the negative direction on the CAT indicates less impact of COPD severity on a patients HRQOL (p.6, third paragraph) and an improvement in CRQ-D scores of ≥0.5 point are considered clinically relevant (p.6, last paragraph).

27. Page 9. “We found that incorporation of ADL simulation training into Traditional PR is superior to Traditional PR in significantly improving patient’s HRQOL measured by CAT score and CRQ Dyspnea score despite the lack of a significant difference in six-minute walk test.” This is not (yet) a conclusion of your study. Authors found significant differences in the ADL group. This, however, does not necessarily means there is superiority as statistical treatment is inadequate.

We have carefully redone the statistical analyses using repeated measures ANOVA as suggested by the reviewer have tone down our conclusions to reflect that a randomized-controlled trial will be needed to confirm these initial findings (p.14 last paragraph, p. 15).

28. Page 10. “ In addition, while patients were encouraged to practice resistance training specific to ADLs at home, it is likely that the compliance to these difficult exercises is low without on-site supervision.”. This remains controversial in the literature. Have you controlled it?

Similar to other observational studies in pulmonary rehab, we do not have accurate data on home adherence to resistance training or home adherence to exercise overall. We will include this as a limitation: “we did not have data on home adherence to resistance training or to exercise prescription overall which could have partially explained the observed differences between the groups” (p. 14, last paragraph).

We are grateful for the insightful comments that made this a well-rounded, higher quality manuscript.

Sincerely,

Kayla Mahoney, MS & Wen-Chih Wu, MD

Attachment

Submitted filename: rebuttal letter-Mahoney.docx

Click here for additional data file. (27.5KB, docx)

Decision Letter 1

Vinicius Cavalheri

4 Aug 2020

PONE-D-20-05739R1

Efficacy of Adding Activity of Daily Living Simulation Training to Traditional Pulmonary Rehabilitation on Dyspnea and Health-Related Quality-of-life

PLOS ONE

Dear Dr. Wu,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by 28 August 2020. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols

We look forward to receiving your revised manuscript.

Kind regards,

Vinicius Cavalheri, Ph.D., MSc

Academic Editor

PLOS ONE

Additional Editor Comments (if provided):

Dear Dr Wen-Chih Wu,

Thank you for addressing the comments from the Reviewers.

There are only two minor changes suggested by Reviewer #1. Can I please ask you to address the two minor changes?

Many thanks

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: (No Response)

Reviewer #3: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #3: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #3: No

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The manuscript called “Efficacy of Adding Activity of Daily Living Simulation Training to Traditional Pulmonary Rehabilitation on Dyspnea and Health-Related Quality-of-life” improved after revision but remain some details that needs the authors attention.

Methods:

Pag 5-6 – “…Out of the 142 patients enrolled between October 2016 and August 2017 (pre-implementation period), 51 (35.9%) patients…, These patients…and personal reasons.” It is Results, not Methods. I suggest the authors transfer that paragraph to the beginning of results.

Suggestion to reduce the study limitations – The authors said “The questionnaires used to assess HRQOL,15 dyspnea and fatigue were not validated for non-COPD patients”

Looking the table 1 the authors has 59 COPD patients on EC-PR group and 54 on TPR group, the others chronic lung disease together adds 46 individuals in each group. The authors might do the separately analyzes of data COPD and not COPD. Perhaps the authors could do a separate analysis of COPD and non-COPD data. In my opinion, this will make the result stronger.

Reviewer #3: The authors have made substantial improvement a to the manuscript. I believe the manuscript is now suitable for publication.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #3: No

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PLoS One. 2020 Aug 27;15(8):e0237973. doi: 10.1371/journal.pone.0237973.r004

Author response to Decision Letter 1

4 Aug 2020

August 4, 2020

PONE-D-20-05739

Efficacy of Adding Activity of Daily Living Simulation Training to Traditional Pulmonary Rehabilitation on Dyspnea and Health-Related Quality-of-life

PLOS ONE

Dear Editor and Reviewers,

Thank you for the opportunity to allow us to improve the manuscript. A draft with track changes in the manuscript was also submitted along with a clean version. Please see below an item to item response to the reviewer’s comments in red.

Reviewer #1: The manuscript called “Efficacy of Adding Activity of Daily Living Simulation Training to Traditional Pulmonary Rehabilitation on Dyspnea and Health-Related Quality-of-life” improved after revision but remain some details that needs the authors attention.

1. Methods:

Pag 5-6 – “…Out of the 142 patients enrolled between October 2016 and August 2017 (pre-implementation period), 51 (35.9%) patients…, These patients…and personal reasons.” It is Results, not Methods. I suggest the authors transfer that paragraph to the beginning of results.

Paragraph has been transferred to the beginning of the results.

2. Suggestion to reduce the study limitations – The authors said “The questionnaires used to assess HRQOL,15 dyspnea and fatigue were not validated for non-COPD patients”. Looking the table 1 the authors has 59 COPD patients on EC-PR group and 54 on TPR group, the others chronic lung disease together adds 46 individuals in each group. The authors might do the separately analyzes of data COPD and not COPD. Perhaps the authors could do a separate analysis of COPD and non-COPD data. In my opinion, this will make the result stronger.

A subgroup analysis on the patient self-reported outcomes by COPD status was added as a supplemental table 2 and to results: “Subgroup analysis by COPD status was described in Supplemental Table 2. The change from baseline in CAT scores was significantly greater for the Energy Conservation versus Traditional PR in the COPD group (p=0.03) and trended towards significance in the non-COPD group (p=0.06). The change from baseline in the remaining outcomes (CRQ-dyspnea, CRQ-Fatigue, MMRC, six-minute-walk test) was similar between the Energy Conservation and the Traditional PR groups in both the COPD and non-COPD patients.” In the results section, the regression analysis does not show that the Patient outcomes significantly changed by COPD status. This was added. “Regression analyses using multiplicative interaction did not show any of the above results to significantly differ by COPD status (all P values >0.25)” (last paragraph, p. 11 and first paragraph, p. 12).

As result, we also deleted the sentence from limitations of “The questionnaires used to assess HRQOL, dyspnea and fatigue were not validated for non-COPD patients”.

We are grateful for the insightful comments that made this a higher quality manuscript.

Sincerely,

Kayla Mahoney, MS & Wen-Chih Wu, MD

Attachment

Submitted filename: rebuttal letter-Mahoney-wu.docx

Click here for additional data file. (18.9KB, docx)

Decision Letter 2

Vinicius Cavalheri

7 Aug 2020

Efficacy of Adding Activity of Daily Living Simulation Training to Traditional Pulmonary Rehabilitation on Dyspnea and Health-Related Quality-of-life

PONE-D-20-05739R2

Dear Dr. Wu,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Vinicius Cavalheri, Ph.D., MSc, BSc (PT)

Academic Editor

PLOS ONE

Acceptance letter

Vinicius Cavalheri

12 Aug 2020

PONE-D-20-05739R2

Efficacy of Adding Activity of Daily Living Simulation Training to Traditional Pulmonary Rehabilitation on Dyspnea and Health-Related Quality-of-life

Dear Dr. Wu:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Vinicius Cavalheri

Academic Editor

PLOS ONE

Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 Table. Comparison of patients who completed the pulmonary rehabilitation versus drop-out.

    (DOCX)

    Click here for additional data file. (24.6KB, docx)
    S2 Table. Comparison of the change from baseline in patient outcomes between energy conservation vs. traditional pulmonary rehabilitation by COPD status.

    (DOCX)

    Click here for additional data file. (26.9KB, docx)
    Attachment

    Submitted filename: rebuttal letter-Mahoney.docx

    Click here for additional data file. (27.5KB, docx)
    Attachment

    Submitted filename: rebuttal letter-Mahoney-wu.docx

    Click here for additional data file. (18.9KB, docx)

    Data Availability Statement

    Data cannot be shared publicly because of HIPAA regulations. A de-identified copy of the Data are available from the Miriam Hospital Institutional Ethics Committee (contact via email to Adrienne McParlin: amcparlin@lifespan.org) for researchers who meet the criteria for access to confidential data.

    Articles from PLoS ONE are provided here courtesy of PLOS

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