Manzak 2020.
Study characteristics | ||
Methods |
Study design: RCT Total duration of study: 8 weeks Details of any run‐in period: None stated Number of study centres and location: Single site. Turkey Study setting: Home based Withdrawals: Not stated Date of study: Commenced February 2019 |
|
Participants |
Number recruited: Not stated Number completed: Intervention group (14). Control group (16) Mean (SD) age: Intervention group 42 (12.7) years. Control group 44.5 (13.2) years Age range: Not stated Gender (M/F): Not stated Mean (SD) BMI: Intervention group 28.1 (6.8) kg/m2. Control group 30.8 (8.6) kg/m2 Severity of condition: Not stated Diagnostic criteria: Not stated Baseline lung function: Not stated Smoking history: Not stated Asthma treatment: Not stated Inclusion criteria: Diagnosis of asthma. Age 18 to 65 years Exclusion criteria: Presence of an orthopaedic, neurological, or systemic disease that prevents exercise. Presence of mental, communicative, and behavioural disorders that may cause problems in understanding commands and questions or practising exercises. Exercising 3 or more days a week |
|
Interventions |
Intervention: 8 weeks home‐based PRP consisting of stretching exercises, strengthening exercises for upper and lower extremities, breathing exercises, and regular physical activity such as walking. Minimum of 3 days per week, with 1 session supervised by a physiotherapist. Also provided with a pedometer and exercise diary Comparison: Booklets on breathing exercises and physical activity in addition to 1 education session on the course of the disease. Also provided with a pedometer and exercise diary Concomitant medications: Not stated Excluded medications: Not stated |
|
Outcomes |
Primary outcomes: Functional capacity (Change in 6MWD from baseline to 8 weeks). Lung function (change in PEF and FEV1 from baseline to 8 weeks). Asthma control (change in ACT score from baseline to 8 weeks). Dyspnoea (change in MRCD score from baseline to 8 weeks) Secondary outcomes: Lower extremity strength and balance (change in 30‐second sit to stand test from baseline to 8 weeks). Health‐related quality of life (change in SGRQ from baseline to 8 weeks). Activities of daily living (change in LCADL score from baseline to 8 weeks) Time points reported: Baseline and 8 weeks |
|
Notes |
Funding: Not stated Notable conflicts of interest: Not stated |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation not stated. |
Allocation concealment (selection bias) | Unclear risk | No detail on allocation concealment provided. |
Blinding of participants and personnel (performance bias) Subjectively reported outcomes | High risk | “Masking: None (open label)” |
Blinding of participants and personnel (performance bias) Not subjectively reported outcomes | High risk | “Masking: None (open label)” |
Blinding of outcome assessment (detection bias) Subjectively reported outcomes | Unclear risk | Blinding not stated in trials registry. |
Blinding of outcome assessment (detection bias) Not subjectively assessed outcomes | Unclear risk | Blinding not stated in trials registry. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Abstract data only. Dropouts not reported upon. |
Selective reporting (reporting bias) | Unclear risk | Abstract data only. Dyspnea (primary outcome) and LCADL (secondary outcome) not reported. |
Other bias | Unclear risk | Insufficient detail provided to accurately determine other bias (abstract only). Retrospectively registered ‐ study start date was before trial registration date on www.clinicaltrials.gov |