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. 2023 Feb 28;33:101097. doi: 10.1016/j.conctc.2023.101097

Design of Lung Transplant Go (LTGO): A randomized controlled trial evaluating the efficacy of a telerehabilitation behavioral exercise intervention to improve physical activity, physical function, and blood pressure control after lung transplantation☆

Melissa L Vendetti a, Seol Ju Esther Moon a, Christopher C Imes a, Andrea Hergenroeder b, Frank Sciurba c, Elizabeth Lendermon c, Joseph Pilewski c, Dianxu Ren d, Bambang Parmanto e, Barbara Dewhirst a, Bryan Willey a, Kristen Jones a, Matthew R Morrell f, Pablo Sanchez g, Annette DeVito Dabbs a,∗
PMCID: PMC9999171  PMID: 36911577

Abstract

Background

Lung transplantation is an established treatment option for persons with advanced lung disease. After transplantation, lung function typically returns to near normal levels, however exercise capacity remains low due to chronic deconditioning, limited physical function, and inactive lifestyles which undermine the intended benefits of the highly selective, resource-intensive transplant procedure. Pulmonary rehabilitation is recommended to improve fitness and activity tolerance, however due to multiple barriers, lung transplant recipients either never participate, or fail to complete, pulmonary rehabilitation programs.

Purpose

To describe the design of Lung Transplant Go (LTGO), a trial modified for the remote environment based on recommendations to preserve trial integrity during COVID. The aims are to evaluate a behavioral exercise intervention to improve physical function, physical activity, and blood pressure control in lung transplant recipients conducted safely and effectively using a telerehabilitation (telerehab) platform, and to explore the role of potential mediators and moderators of the relationship between LTGO and outcomes.

Methods

Single-site, 2-group randomized controlled trial with lung transplant recipients randomized 1:1 to either the LTGO intervention (a 2-phased, supervised, telerehab behavioral exercise program), or to enhanced usual care (activity tracking and monthly newsletters). All study activities, including intervention delivery, recruitment, consenting, assessment, and data collection, will be performed remotely.

Conclusion

If efficacious, this fully scalable and replicable telerehab intervention could be efficiently translated to reach large numbers of lung recipients to improve and sustain self-management of exercise habits by overcoming barriers to participation in existing, in-person pulmonary rehabilitation programs.

Keywords: Lung transplant, Telerehabilitation, Randomized controlled trial, Behavior change techniques, Self-monitoring

1. Introduction

Lung transplantation is an established treatment option for persons with advanced lung disease to gain quality of life and prolong survival [1,2]. Overall survival rates for lung transplant recipients (LTR) are currently up to 89% and 61% at 1 and 5 years, respectively [3], despite the recent widening of selection criteria to include more older-aged adults and persons with co-morbidities [1].

Prior to transplant, the respiratory limitations of advanced lung disease reduce ventilatory capacity, leading to disabling dyspnea and fatigue, which restrict physical activity and exercise tolerance. The resultant inactivity leads to changes in skeletal muscle groups consistent with sarcopenia [4]. The prevalence of frailty among patients referred for transplant ranges from 58 to 82% [[5], [6], [7], [8], [9]]. Thus, patients can be often severely deconditioned when they undergo transplantation.

After transplant, the goal is for lung function to return to near normal levels [10,11], and LTRs report improvements in quality of life compared with pretransplant values [12]. However, the limited exercise capacity (40–60% of predicted values) often persists in part due to delayed recovery of muscle strength [13,14]. Side effects of immunosuppression further reduce lean muscle mass [15]. Other factors that contribute to persistent deconditioning include the immobility of prolonged hospital recovery and frequent re-hospitalizations [16]. Consequently, daily sedentary time remains significantly increased in LTR compared to healthy individuals [17].

Overwhelming evidence supports the benefits of pulmonary rehabilitation (PR) to improve functional exercise capacity in persons with end-stage lung disease, including transplant candidates and recipients [4,18]. Therefore, PR is prescribed to optimize functional status in LTRs [19]. Yet, despite its potential benefits, PR is universally underutilized, and referral, uptake and completion rates are alarmingly low [20].

Studies of remote options for delivering PR show promise [21,22]. However, the studies to date are small, retrospective, or lack comparison groups [23,24]. A rigorous randomized controlled trial (RCT) is needed to determine whether a telerehabilitation (telerehab) option will increase access, uptake, and completion of PR, and improve functional capacity and physical activity after lung transplantation [[25], [26], [27], [28]].

Lung Transplant Go (LTGO) was designed to evaluate a behavioral exercise intervention to improve physical function, physical activity and blood pressure control for LTR in their homes via a telehealth platform. While the telerehab intervention was always delivered remotely, the assessments were initially delivered in-person. This report describes the final protocol that was modified to be fully remote while preserving trial integrity during the pandemic [29,30].

2. Background

Limited physical function and an inactive lifestyle after lung transplant compromise the overall intended benefits of this highly selective and resource-intensive procedure [10,11]. Few RCTs have evaluated exercise interventions in LTR and only one trial focused on physical function and physical activity [18]. In that RCT (n = 40), outcomes were compared for LTR who enrolled in a 3-month clinic-based exercise intervention versus usual care. At 12 months, LTR in the intervention group showed greater improvement in daily walking time, 6-min walk distance, quadriceps muscle force, and reduced need for anti-hypertensive therapy. These results support the ability of exercise training to improve physical function, physical activity and blood pressure (BP) control, however, the trial had limitations— the intervention was clinic-based versus delivered remotely, the refusal rate was high (40% of eligible LTR chose not to enroll due to travel issues), the active intervention was brief (3 months) and did not include a maintenance phase or the behavioral strategies known to sustain benefits of a formal exercise training program [19].

We posit that characteristics inherent to in-person PR programs impact initiation and long-term adherence to exercise in LTR. Barriers include lack of access to local PR programs, low uptake and completion rates (especially for people living in rural areas with limited incomes who lack insurance coverage for PR), lack of transportation, scheduling issues, or disruption of usual routines [31,32]. Other barriers include low referral and participation rates for persons with frailty, lack of awareness of the benefits of PR to reverse frailty, and recognition that untreated frailty is an independent predictor of completion of PR [33].

Furthermore, during in-person PR, exercise occurs under close clinician supervision but, afterward, LTR are expected to continue unsupervised exercise at home while many do not feel confident to exercise alone [34]. Importantly, while behavioral strategies essential to achieving exercise goals, sustaining exercise self-management, and maintaining an active lifestyle, are included in guidelines for PR programs, implementation may vary widely. The delivery and receipt of specific behavior change techniques and promotion of exercise self-efficacy may not always be documented or considered in the analysis of impact of traditional in-person PR programs. Consequently, LTR may have little opportunity to establish behavior patterns that promote continued exercise self-management.

Telerehab offers a flexible and sustainable alternative with the potential to promote and sustain exercise self-management. Telerehab uses telecommunication and computing technology to assess patients and deliver interventions in LTR homes [35,36]. The efficacy of telerehab interventions has been confirmed in RCTs in other populations, e.g., knee arthroplasty and stroke [[37], [38], [39]]. To date, no RCT has evaluated a telerehab exercise intervention that incorporates behavioral strategies and a maintenance phase for self-management of exercise after lung transplantation.

3. Study purpose

The overall goal of the study is to evaluate the efficacy of LTGO in improving physical function, physical activity, and BP control in LTR compared to the enhanced usual care group (EUC).

The conceptual framework integrating our hypotheses is shown in Fig. 1. We hypothesize that participants assigned to LTGO will show greater improvements in physical function and physical activity between baseline and 3 months and greater sustained improvement at 6 months (primary outcomes). We also hypothesize that LTGO will be more efficacious for preventing new onset or controlling existing hypertension (secondary outcome) than those assigned to EUC. Exercise self-efficacy and adherence to self-monitoring will mediate the effects (exploratory aim 1) and a variety of sociodemographic, clinical, and other factors will moderate the intervention effects (exploratory aim 2).

Fig. 1.

Fig. 1

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Conceptual framework.

4. Study methods

4.1. Design

The study is a two-group, RCT, approved by the University of Pittsburgh Institutional Review Board (STUDY19020357). Enrollment commenced April 2019 and recruitment is ongoing.

4.2. Setting

The study is being conducted at one of the world's largest lung transplant programs which is affiliated with an academic tertiary medical center in the Mid-Atlantic region of the U.S. All study activities, including recruitment, intervention delivery and outcome assessments are completed remotely with participants in their homes using a 2-way, Health Insurance Portability and Accountability Act compliant videoconference platform.

4.3. Study Process: recruitment, screening, enrollment, randomization and assessment

See Table 1 for Study Eligibility Criteria. See Fig. 2 for Study Process. Researchers check medical records for transplant patients and verify inclusion and exclusion criteria with the transplant physician. If eligible patients are interested, they are screened for sufficient internet speed. Participants who enroll in PR (current standard of care) may defer the start of the LTGO study. After informed consent, a member of the project team calls the participant to provide instructions for setting up the 2-way video communication equipment.

Table 1.

Study eligibility criteria.

Inclusion Criteria Exclusion Criteria
  • •

    Underwent a lung transplant procedure (including re-transplant)
  • •

    Underwent a multi-organ transplant
  • •

    >18 years of age
  • •

    Declined to be asked screening questions, or declined an introduction to the research team to hear about research
  • •

    Able to read and write English
  • •

    Medical issue precluding participation
  • •

    >4 weeks post lung transplantation surgery
  • •

    Have other chronic conditions that may severely limit participation in exercise training, e.g., cardiac, musculoskeletal, or cognitive impairments
  • •

    Discharged to home after lung transplant surgery
  • •

    No home internet or smart device with Bluetooth capabilities
  • •

    MD report of difficulty walking ¼ mile or climbing 10 steps without resting
  • •

    Concurrent participation in a formal exercise program, e.g., pulmonary rehabilitation, during the active eligible study period, with no plans to stop formal exercise
  • •

    Transplant physician confirms patient eligibility
  • •

    >18 months post-transplant hospital discharge (time/scheduling delays, transportation issues, etc.)
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Fig. 2.

Fig. 2

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Study process: Recruitment, screening, enrollment, randomization, and assessment.

After completion of a baseline assessment, participants are randomized 1:1 to either LTGO or EUC groups. To achieve equivalency for known differences in exercise capacity, a blocked randomization scheme stratified by sex and length of hospital stay (≤2 weeks or >2 weeks) is used as an indicator of hospital-associated deconditioning [40,41]. The target for a powered sample size based on effect sizes measured by Cohen's d ranged from 0.64 to 1.45 across outcome variables at 12 months [18]. A sample of 80 subjects (40/group) will have 80% power to detect an effect as small as 0.64 (α = 0.05, two-tailed) for measures of physical function, physical activity, and blood pressure control.

4.4. LTGO intervention description

Our intervention protocol [42] was developed based on the American Association of Cardiovascular and Pulmonary Rehabilitation Guidelines [43] for PR. A structured progression protocol [43] was developed for LTGO so that the interventionist follows a replicable approach to prescribe and progress the exercise prescription based on the participant's current fitness level. Walking is the primary physical activity prescribed; however, other forms of physical activity are considered acceptable alternatives. Structured exercises include strength, balance, and flexibility training and gradually increasing targets for steps per day.

4.4.1. Phase I: exercise training and behavioral coaching (12 weeks)

Initial equipment set-up and orientation. The interventionist contacts participants by phone to confirm that study equipment (training material, web camera, adjustable ankle/wrist weights, BP monitor, and pulse oximeter) was delivered to their home. During the initial session, the participants are assisted in choosing an appropriate exercise location in their home. The interventionist asks the participant to set their exercise-related goals and ensures that these goals align with the goals of the LTGO program (e.g., improving strength, increasing endurance, or having more energy). The participants are shown how to use the equipment and tools to monitor BP, heart rate, oxygen saturation, an activity tracker for steps per day (Fitbit Charge 3), and Borg scale for rating perceived exertion for breathing and legs. The interventionist explains the safety procedures, (see the Supplementary Material File 2: Summary of Safety Protocols) including when it is safe to begin exercise and how to manage signs and symptoms that may arise during exercise. If the participant's vital signs indicate it is safe to exercise, then the interventionist will supervise the exercise session. Once the exercise session concludes, the interventionist introduces the Participant Orientation Manual where weekly exercise can be documented (See Supplementary Material File 3: LTGO Participant Orientation Manual).

Weekly sessions 1–12. The interventionist and participant log on to the 2-way video communication system allowing both parties to interact virtually. Each session is audio and video recorded and used to monitor intervention fidelity. Each session includes the following activities:

Interactive exercise training. The interventionist begins each session by inquiring about any changes to the participant's health condition or vital signs that may preclude exercise. The weekly reported step count on the Fitbit activity tracking portal, developed for the LTGO study, is reviewed. Should the participant achieve the previous week's step count goal on at least one day, then the step count goal is increased by 10%. Weekly exercise includes warm up, upper and lower extremity strength training, balance exercises, and a cool down period. To minimize risk of injury and increase exercise effectiveness, the interventionist provides verbal instructions and visual demonstrations of the exercises by using proper form and supervises the participant while they perform the exercises. The interventionist also inquires about progress in achieving goals to increase activity, discusses barriers and solutions, and adjusts the exercise prescription for the week according to the progression model protocol.

Behavioral coaching. Over the course of Phase I, the interventionist introduces eight behavior change concepts: including SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) goal setting, exercise monitoring, the frequency, intensity, time, and type (FITT principle), breathing techniques, time management, dealing with setbacks and barriers, social support, and stress management. Each week the interventionist introduces a behavior change concept with an assignment for the participant to practice applying on their own. The interventionist also assesses the participant's self-efficacy (confidence that they will follow their exercise prescription) on a scale of 1–10 (1 is least confident). Behavioral coaching topics were modeled on the physical activity component of the Diabetes Prevention Program and other behavior change techniques [45].

Timing of sessions. LTRs will complete at least 10 weekly sessions in Phase I before they can move on to Phase II. From our pilot study, we learned that scheduled sessions may be delayed due to complications after lung transplant (e.g., infection, acute rejection; typically, both respond quickly to treatment) [46]. If a session is cancelled, weekly phone contact will be maintained and the virtual session will be rescheduled until participants have completed at least 10 sessions through the end of the study.

During the final session of phase I, the interventionist will assist the participant to develop a behavioral contract to follow in Phase II, including setting monthly goals, developing ways to self-monitor goals, anticipate barriers, and continue using strategies to overcome challenges.

4.4.2. Phase II: transition to self-management of exercise (12 weeks)

Monthly phone calls. The aims of Phase II are to support sustained adherence to established exercise routines, self-monitoring of exercise, and to build skills to promote maintenance of physical activity in daily life. Phase II consists of three-monthly telephone counseling sessions that last ∼30 min/each. The interventionist and participant review the progress of the behavioral contract together to guide the use of problem-solving strategies to reduce barriers to increasing physical activity, assess the progress of the participant, and adjust SMART goals if needed. Participants also receive materials that address behavioral strategies for maintaining exercise that are an extension of behavioral coaching topics and skill building from Phase I and are encouraged to continue to increase daily physical activity and self-monitoring. During the final session of Phase II, the interventionist assists the participant to generate an individualized plan for long-term self-management of exercise.

4.5. Enhanced usual care

Usual care for LTR is encouragement by the transplant team to participate in structured exercise activity [47]. The EUC group is provided a Fitbit to monitor steps per day and given a printed instruction manual developed for the LTGO study which explains how to install and use the activity tracker. LTR also receive six monthly newsletters on health topics related to lung transplant (e.g., food safety, environmental health, flu, mental health, skin care and oral health).

4.6. Baseline and follow-up assessments

A baseline assessment is performed prior to randomization. Patient participation in formal exercise after randomization to either group is tracked and controlled for in the analysis (see Table 2: Potential Moderators). All participants are assessed at 3- and 6-months post-randomization. A researcher (blinded to group assignment) performs physical function assessments via the 2-way video, administers questionnaires online via REDCap, retrieves physical activity data from the Actigraph GT3X and Fitbit devices, and abstracts clinical data from the electronic medical record. All participants receive $20 per completed research assessment. Participants in the LTGO group receive an additional $20 for completing semi-structured interviews about the intervention.

Table 2.

Summary of measures.

Variables Variable description Measures Time of Measurement
Base 3 M 6 M
Primary Outcomes
Physical function Physical performance and wellbeing St. George Respiratory Questionnaire [48,49] X X X
Balance Berg Balance Scale [[50], [51], [52]] X X X
Lower body strength 30-Second Chair to Stand [53,54] X X X
Physical activity Walking Average Steps per day for 14 days [55,56] X X X
Time spent in sedentary, light, moderate and vigorous activities Actigraph GT3X for 7 Days [57,58]
IPAQ-S [59,60]		 X X X
Secondary Outcome BP Control BP categories and therapies ACC/AHA Blood Pressure Guidelines [61] X X X
Potential Mediators
Self-monitoring Adherence to self-monitoring % of days with Fitbit≥150 SPD [55,56,62] X X X
Self-efficacy Exercise self-efficacy Self-Efficacy to Regulate Exercise [63] X X X
Potential Moderators
Sociodemographic characteristics Age, sex, race, ethnicity, education, income, marital status Sociodemographic questionnaire X
Experience with information technology ITFQ [64] X
Quality of relationship with primary lay caregiver Dyadic Adjustment Scale [65] X X X
Clinical characteristics, pre-transplant Underlying lung diagnosis, type of transplant (single or bilateral) EHR X
Clinical characteristics, post-transplant Comorbidities, complications, readmissions EHR, Charlson Comorbidity Index [66] X X X
Symptoms after lung transplant QLTP [67,68]
Psychological distress SCL-90-R (Anxiety and depression subscales) [69,70] X X X
Sleep quality PSQI [71] X X X
Concurrent exercise program participation Physical Activity and Exercise Survey X X X
LTGO group only Usability of telehealth platform TUQ [64] X
LTR experience of LTGO intervention Semi-structured interview X X
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Notes: IPAQ-S=The International Physical Activity Questionnaire Short Form; ACC/AHA = American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines BP = blood pressure; EHR = electronic health record; ITFQ=Internet Technology Familiarity Questionnaire; QLTP = Questionnaire for Lung Transplant Patients; SCL-90-R = Symptom checklist 90-revised PSQI=Pittsburgh Sleep Quality Index; PAES=Physical Activity and Exercise Survey; TUQ = Telehealth Usability Questionnaire.

4.7. Study measures

Data collection measures are presented in Table 2. Summary of Measures. Recent recommendations for preserving trial integrity during the COVID pandemic guided the transition to collect all measures remotely [29,30]. (See Supplementary Material File 1: Description of Measures).

4.8. Data management

Longitudinal data are collected and managed using REDCap (Research Electronic Data Capture) tools hosted at The University of Pittsburgh [72]. All REDCap data are exported to SPSS (IBM v. 27.0). Study 360 (R-track) [73], created at the University of Pittsburgh, and is used to track study due dates and communication with participants.

4.9. Proposed analyses

Preliminary Analyses. All statistical analyses will be conducted using SAS v. 9.4 (SAS Institute Inc.). Preliminary analyses will: 1) describe distributions; 2) identify any group imbalances and associations between outcome variables and potential covariates; 3) evaluate patterns of missing data; and 4) check for violations of the statistical assumptions for the planned analyses. Appropriate data transformations will be performed, if necessary. The groups will be compared to ensure that randomization resulted in equivalent distribution of sample characteristics. If any covariate (i.e., highly correlated to primary outcome) is disproportionately distributed across groups, it will be adjusted in future analyses. The analyses will control for the interval between transplant, the baseline data assessment, and exercise activities outside the study.

Primary Analyses by Specific Aim. An ‘intent-to-treat' (ITT) approach will be used for efficacy analyses, where all participants are included in the treatment groups to which they were randomly assigned, regardless of protocol adherence, treatment received, withdrawal, or protocol deviations. The sensitivity of the results assumes that ITT will be explored using information collected regarding intervention fidelity and dosage (e.g., adherence to sessions).

Evaluate efficacy of LTGO in improving physical function, physical activity, and BP control from baseline to 3- and 6-months post-randomization. A repeated-measures random-effect mixed model will be used as the main approach to examine the difference in outcomes (e.g., physical performance, well-being, and physical activity) between the two groups. Correlations between repeated measurements will be induced by including random effects (e.g., a random intercept for each participant) or by using an appropriate covariance structure in modeling. The inclusion of an interaction term between the group and time variables will help identify whether the intervention effect differs by time. An appropriate linear contrast will be constructed for post-hoc multiple comparisons. In all models, we will adjust the important covariates identified from our initial exploratory analysis. Linear mixed models will provide a flexible method for examining longitudinal data. These models allow for: 1) unequally spaced observations among participants and 2) different numbers of observations per participant and are therefore robust to most types of missing data. Both time-invariant and time-varying variables, as well as multiple random effect terms, can be included in these models. All models will include a random intercept to induce suitable correlation between repeated observations from the same participant. Additional random effects, such as participant-specific time effect, and a variety of error covariance structures will be considered to determine the most suitable model. Standard model diagnostics, such as residual examination, will be used to identify outlying and influential observations and violation of assumptions.

Examine the potential mediation effects of exercise self-efficacy and self-monitoring of exercise on physical function, physical activity, and BP control. Mediation analysis (path analysis) will be used. Four steps will be performed with three regression equations to establish whether a variable mediates the relationship between a predictor and outcome variable. Step 1: Show that LTGO is correlated with physical function, physical activity, and BP control. This step establishes that a mediating effect exists. Step 2: Show LTGO is correlated with mediator (self-monitoring or self-efficacy). This step involves treating the mediators as if they were outcome variables. Step 3: Show that the mediators affect physical function, physical activity, and BP control. Physical function, physical activity and BP control will be used as dependent variables in a regression equation, whereas LTGO Intervention, self-monitoring (or self-efficacy) will be used as predictors. Step 4: To establish that self-monitoring or self-efficacy completely mediates the LTGO intervention in terms of improved physical function, physical activity and BP control, the effect of LTGO on physical function, physical activity and BP control that control the potential mediator of self-monitoring (or self-efficacy) should be zero. If the first three steps are met, but Step 4 is not met, then partial mediation is indicated. The mediation effect will be evaluated for statistical significance.

Examine potential moderating effects sociodemographic and clinical factors on physical function, physical activity, and BP control. The previously described regression models will be expanded to include main effect terms for sociodemographic and clinical factors and the two-way interaction terms between the main effect terms. Regression models will be estimated in a hierarchical manner, in which the main effect terms in the first block and their corresponding interaction terms will be entered in the second block. Appropriate model statistics (e.g., estimated regression coefficients [with 95% CI] for interaction terms, change statistics based on likelihood ratio test, and F-statistics) will be used to evaluate moderation effects.

5. Quality control

Participant Safety. The safety protocols for performing supervised and self-directed exercise sessions and outcome assessments, including handling reports of suicidal ideation are included (See Supplementary Material File 2: Summary of Safety Protocols).

Staff Training. All staff are trained in study background; standards of care after lung transplant; overview and practice of therapeutic communication; using study technology (e.g., the 2-way video communication system, Fitbit, and Actigraph GT3X); and conducting informed consent. The LTGO interventionist has a master's degree in exercise physiology and clinical experience in cardiopulmonary rehabilitation. Orientation to the delivery of the intervention and implementation of the progression model is supervised by a licensed physical therapist. The research project staff have formal exercise training through education or work experience (e.g., licensed trainer, degree in exercise related program, taught and led exercise classes). Staff who are blinded to group assignments are trained to perform remote baseline and follow-up assessments. Quality assurance checks for compliance with assessment procedures are conducted quarterly by a PhD-prepared nurse with expertise in assessments of physical function and any drift is remediated.

Intervention fidelity monitoring (IFM). All intervention sessions are recorded to assess intervention fidelity using a monitoring tool based on the critical content and progression model. Each recording is independently reviewed to measure LTGO intervention adherence [74]. Interrater reliability between two independent reviewers will be calculated for every 10th recording and discrepancies in ratings are resolved by consensus. Remediation for interventionist training is implemented for fidelity drift below 90%.

Data Safety Monitoring (DSM). Procedures for identifying, reviewing, and reporting adverse events or unanticipated issues are addressed. Project staff are trained to address safety issues, report events, and document study issues. Consistent with NIH policy, a DSM medical monitor is sufficient [75]. The independent data safety monitor for LTGO is a pulmonologist who has expertise in clinical research. The medical monitor is available in real time to review serious adverse events and recommend appropriate actions to mitigate issues.

6. Discussion

The LTGO study is one of the first RCTs to evaluate an alternative approach to in-person PR in LTR that combines supervised exercise training with behavioral strategies to promote exercise self-management via a telerehab platform. The LTGO intervention is unique in several ways: LTGO is grounded by behavior change theory and includes a combination of self-monitoring and other evidence-based behavior change strategies, i.e., observable, replicable components of an intervention designed to alter or redirect processes that regulate behavior and enhance self-efficacy [62]. These strategies include: 1) incremental goal setting to facilitate mastery performance as LTR pace their individual exercise and physical activities; 2) self-monitoring of daily physical activity and exercise with interventionist feedback; 3) development of problem-solving skills to use when encountering barriers to long-term adherence; 4) behavioral coaching to engage LTR in developing skills to self-manage physical activity in their daily lives and maintain exercise as a sustained habit.

Furthermore, all study activities including recruitment, outcome assessments, and intervention delivery can be conducted remotely. Since LTR participate in LTGO from home, they no longer face many of the barriers that limit participation and completion of in-person PR. The ability to deliver the telerehab intervention completely remotely offers a sustainable approach to improving self-management of exercise, improving physical function, physical activity, and overcoming barriers to exercise.

Since no transplant-specific guidelines exist for exercise rehabilitation after lung transplantation, the LTGO intervention includes a novel, replicable, structured exercise progression protocol developed for this study based on the participant's fitness level and ability to advance overtime [44]. The weekly exercise sessions include individualized, supervised exercise training plus behavioral coaching using a telerehab platform for 12 weeks (Phase 1), followed by monthly telephone behavioral coaching for 12 weeks to promote transition to successful self-management (Phase 2). The addition of the maintenance phase, guided by an individualized behavioral contract, enhances participants' ability to sustain self-management of exercise with waning support of an interventionist overtime.

LTGO will be the first large scale RCT to evaluate the efficacy of a telehealth-delivered behavioral exercise intervention to prevent new onset or control existing hypertension after lung transplant. Benefits of exercise include prevention and control of hypertension, an adverse effect of immune suppression. Approximately 40% of LTR require treatment for new onset hypertension in their first-year post-transplant and up to 70% of LTR are on antihypertensives by year five [76]. Prior evidence shows that exercise supports cardiovascular health and helps reduce the need for anti-hypertensive therapy, including after lung transplant [18].

The benefits of our study are supported by preliminary data that report the feasibility, safety, and acceptability of the LTGO telerehab exercise training and behavioral coaching, and the ability to improve physical function and physical activity and maintain BP control [46]. Pilot participants have been highly enthusiastic about our approach, saying that LTGO meets their unique needs to increase physical activity.

LTGO limitations include utilizing a single site, which may limit the generalizability of our results to other populations and communities, and the demographics of our regional transplant center may limit the extent to which we can recruit a more diverse sample.

Despite these limitations, the findings of our timely RCT will contribute critical evidence about the efficacy of telerehab in the setting of lung transplantation. The intervention, exercise progression model, and remote assessments are presented in enough detail to be replicated by other researchers and clinicians. Due to the investment of resources for lung transplantation, it behooves us to promote the development and evaluation of exercise interventions that are accessible, acceptable, effective, replicable, and sustainable.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Acknowledgements

We would like to thank Lisa Tamres and Blair Powell for their assistance with Study 360 (R-track) and data management, Heather Eng for her assistance to plot the longitudinal map of the LTGO study for creation into REDCap, the limitless commitment of our research team, and our dedicated research participants for their valuable participation in this important and novel research. We would also like to thank the entire CLC Lung Transplant team, with special mention to Lacy Vasquez, Jenna Keeling, and the lung transplant coordinators, for their crucial support and commitment to help us recruit every potentially eligible lung transplant patient during an everchanging pandemic.

Footnotes

☆

This work was supported by the National Institute of Nursing Research [NINR, NIH, NR017196-4, DeVito Dabbs, PI].

Appendix A

Supplementary data to this article can be found online at https://doi.org/10.1016/j.conctc.2023.101097.

Appendix A. Supplementary data

The following are the Supplementary data to this article:

Multimedia component 1
mmc1.docx (49.7KB, docx)
Multimedia component 2
mmc2.docx (37.3KB, docx)
Multimedia component 3
mmc3.pdf (1.8MB, pdf)

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