Schneiderman‐Walker 2000.
Methods | Design: single‐centre, parallel RCT, 3‐year duration. Inclusion criteria: participants with CF aged 7 ‐ 19 years with an FEV1 > 40% predicted. Exclusion criteria: not specified. |
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Participants | 65 participants with CF; 2 groups similar at baseline. 7 dropouts.
Group demographics Exercise group (n = 30): mean (SD) age 13.4 (3.9 years). Control group (n = 35): mean (SD) age 13.3 (3.6) years. |
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Interventions | Long‐term aerobic study.
Group 1: minimum of 20 min aerobic activity plus 5 min warm up and cool down 3 times per week. Group 2: maintained regular activity (control). |
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Outcomes | Included in this study were: FVC; FEV1; FEF25‐75; PEFR; TV; VO2 peak; VCO₂; peak exercise heart rate; peak exercise VE; VE peak/MVV; RER; blood pressure; % of ideal weight for height; compliance and sense of well‐being; feasibility of exercise; hospital stays and number of days in hospital; chest X‐ray; and Schwachman scores. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation sequence. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not possible to blind participants to intervention. Unclear whether personnel blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Pulmonary function assessors were blinded to group assignment (primary outcome measure). |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Clear description and details about 7 dropouts were recorded. Intention‐to‐treat analysis was reported to yield similar results for pulmonary function. Results were only reported for 65 participants who completed the 2‐year follow up. |
Selective reporting (reporting bias) | Low risk | All outcome detailed in methods were reported in results. Data reported for all time points. |
Other bias | Unclear risk | Groups similar at baseline. Stated the inclusion criteria but not the exclusion criteria. Described statistical methods used in analysis. |