Turk 2020.
Study characteristics | ||
Methods |
Study design: RCT parallel‐group design. 3 groups (PR only (PR), PR + self management support (PR + SMS), usual care). Results of PR only group and usual care group have been extracted for this review. Total duration of study: 1 year Details of any run‐in period: None stated Number of study centres and location: Single site. The Netherlands Study setting: General Hospital Withdrawals: 1 withdrawal from control group Date of study: January 2014 to December 2016 |
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Participants |
Number recruited: Randomised to intervention (PR group): 14. Randomised to control group: 11 Number completed: Completed intervention (PR group): 14. Completed control: 10 Mean (SD) age: Intervention (PR group) 41.5 (9.7) years. Control group 41.9 (8.5) years Age range: Not stated Gender (M/F): Intervention (PR group) 4/10. Control group 1/9 Mean (SD) BMI: Intervention (PR group) 36.72 (4.79) kg/m2. Control group 35.16 (3.86) kg/m2 Severity of condition: Median (IQR) ACQ scores at baseline: Intervention (PR group) 2.17 (1.46 to 2.5). Control group 2.09 (1.50 to 2.68) Diagnostic criteria: Asthma was diagnosed according to GINA guidelines. Baseline lung function: Mean (SD) % predicted FEV1: Intervention (PR group) 86.93 (9.35)%. Control group 82.4 (16.17)% Smoking history: Not stated Asthma treatment: In relation to the entire study population (all 3 groups) at baseline: all participants were using ICS and a LABA; 39% of participants were using a LTRA; and 23% of participants were using a LAMA. Inclusion criteria: Age 18 to 55 years. BMI > 30 kg/m2. Suboptimally controlled asthma (ACQ score > 0.75) despite optimal inhalation therapy (ICS and a LABA) Exclusion criteria: Current smoking or a smoking history of > 10 pack years. Asthma exacerbation (need of antibiotics/oral corticosteroids) in 6 weeks before inclusion. COPD or other pulmonary pathology apart from asthma, except for adequately treated OSAS with an apnoea‐hypopnoea index < 5.0. Any significant orthopaedic or neurologic problems |
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Interventions |
Intervention: High‐intensity interval training x 3 days per week x 12 weeks + nutritional intervention (3 clinical visits and 3 phone calls over 12 weeks) + psychological group sessions focusing on behavioural modification and motivational strategies (4 group sessions of 1‐hour duration) Comparison: Advised to lose weight and to exercise Concomitant medications: All participants were using ICS and a LABA. Excluded medications: None stated |
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Outcomes |
Primary outcomes: Difference of change in ACQ score between PR + SMS and PR only groups after 3 months Secondary outcomes: Difference of change in ACQ score between both PR groups and control group after 3 months. Difference of change in ACQ score between both PR groups and control group at 12 months. Difference of change between PR only group and control group and between PR + SMS group and PR group at 3 months and 12 months for quality of life (AQLQ), lung function, physical activity levels, exercise capacity (incremental CPET on cycle ergometer and 6MWD), body composition, airway inflammation, systemic inflammation and exacerbation rate Time points reported: Baseline, 3 months, 12 months Data reported as mean (SD) change from baseline for outcomes of exercise capacity and physical activity. Data reported as median (IQR) change from baseline for outcomes of asthma control, quality of life, step count, and inflammatory markers. |
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Notes |
Funding: None stated Notable conflicts of interest: None stated Other: Data from the PR only group and usual care group were extracted for review. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Patients were randomly assigned in a 1:1:1 ratio using a computer‐generated permuted‐block scheme”. |
Allocation concealment (selection bias) | Low risk | “Allocation took place by an independent researcher after written consent had been obtained from all subjects and baseline data were collected, ensuring concealment of allocation.” |
Blinding of participants and personnel (performance bias) Subjectively reported outcomes | High risk | "There was no blinding”. |
Blinding of participants and personnel (performance bias) Not subjectively reported outcomes | High risk | "There was no blinding”. |
Blinding of outcome assessment (detection bias) Subjectively reported outcomes | High risk | No mention of blinding of outcome assessor (Subjective measures: ACQ, AQLQ) |
Blinding of outcome assessment (detection bias) Not subjectively assessed outcomes | High risk | No mention of blinding of outcome assessors. (Measures: Lung function, Physical activity level, Exercise capacity, Body composition, Airway inflammation, Systemic inflammation, Exacerbation rate) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | “The data of the randomized subjects were analysed according to the intention to treat principle.” |
Selective reporting (reporting bias) | Low risk | All primary and secondary endpoints stated in trial registry are reported upon. |
Other bias | Unclear risk | Did not achieve target sample size. |
Abbreviations: 6MWD: 6‐minute walk distance; ACO: asthma‐COPD overlap; ACQ: Asthma Control Questionnaire; ACT: Asthma Control Test; AQLQ: Asthma Quality of Life Questionnaire; BDI: baseline dyspnoea index; BFI: Brief Fatigue Inventory; BMI: body mass index; BTS: British Thoracic Society; CI: confidence interval; COPD: chronic obstructive pulmonary disease; CPET: cardiopulmonary exercise test; CRQ: Chronic Respiratory Disease Questionnaire; DEXA: dual energy X‐ray absorptiometry; ESWT: endurance shuttle walk test; FeNO: fractional exhaled nitric oxide; FEV1: forced expiratory volume in 1 second; FRC: functional residual capacity; FVC: forced vital capacity; GAD‐7: General Anxiety Disorder Assessment; GI: glycaemic index; GINA: Global Initiative for Asthma; GOLD: Global Initiative for Chronic Obstructive Lung Disease; HADS: Hospital Anxiety and Depression Scale; HR: heart rate; hs‐CRP: high‐sensitivity C‐reactive protein; ICD‐10: International Statistical Classification of Diseases and Related Health Problems 10th Revision; ICS: inhaled corticosteroids; IL‐6: interleukin 6; IPQ: Illness Perception Questionnaire; IQR: interquartile range; ISWT: incremental shuttle walk test; ITU: intensive therapy unit; LABA: long‐acting beta agonist; LAMA: long‐acting muscarinic antagonist; LCADL: London Chest Activities of Daily Living Scale; LTRA: leukotriene receptor antagonist; MARS‐D: Medication Adherence Report Scale; MRCD: MEdical Research Council Dyspnea Scale; NIHR: National Institute for Health and Care Research; OSAS: obstructive sleep apnoea syndrome; PC20: concentration of inhaled methacholine that provokes a 20% decrease in FEV1; PEF: peak expiratory flow; PHQ‐9: Patient Health Questionnaire‐9; PR: pulmonary rehabilitation; PRP: pulmonary rehabilitation programme; RCT: randomised controlled trial; RM: repetition maximum; SD: standard deviation; SIGN: Scottish Intercollegiate Guidelines Network; SGRQ: St George's Respiratory Disease Questionnaire; SMD: standardised mean difference; TDI: transitional dyspnoea index; VO2 max: maximal oxygen uptake; VO2 peak: peak oxygen uptake.