Schneiderman‐Walker 2000.
Study characteristics | ||
Methods | Randomised controlled study. 3‐year follow‐up period. | |
Participants | 65 children with CF recruited in outpatient setting. Intervention group n = 30, Control group n = 35. Unkown proportion male to female participants. Participants recruited from the CF clinic at the Hospital for Sick Children in Toronto, Canada. Age range: 7 ‐ 19 years. Intervention Group: FEV1 % pred mean (SD) 89.2 (19.5); FVC % pred 92.6 (15.7); FEF25-75 %pred 76.3 (31.2). Lean body mass 38.2 (13.1) kg. Schwachman score (/100) 89.2 (9.1). VO2max 40.6 (7.6) ml/kg/min. Control Group: FEV1 % pred mean (SD) 87.9 (17.8); FVC % pred 90.1 (12.9); FEF25-75 % pred 72.9 (29.2). Lean body mass 34.1 (11.1) kg. Schwachman score (/100) 87.7 (9.5). VO2max 40.7 (7.9) ml/kg/min. |
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Interventions | Intervention Group
Participants in the intervention group were directed to participate in their preferred aerobic activities for 20 minutes on at least 3 occasions in a week (incorporating a warm‐up and cool‐down period). Participants received 1, in‐person counselling session with an exercise physiologist to educate them as to activity requirements for the study, and monitoring techniques. Monitoring techniques were reviewed during clinic (each 12 ‐ 16 weeks) and telephone consultations (each 4 ‐ 6 weeks). Control Group Control group participants were requested to maintain their usual levels of physical activity. Both intervention and control group participants recorded their physical activity in a diary each day during the study period ‐ recording date, activity type, duration and estimate of intensity. |
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Outcomes | Outcomes assessed at yearly intervals after recruitment to the study. Participation in physical activity: activity diary Exercise capacity (VO2max):ml/kg/min ‐ measured by cycle ergometry test using Godfrey protocol. Wmax % predicted Maximum HR: beats/min MaxVE: L/min VEmax/MVV: %/min Pulmonary function: FVC % predicted; FEV1 % predicted; FEF25-75 % predicted; PEFR; MVV Score of exercise compliance: range 0 ‐ 2 Questionnaire on feasibility of implementing regular exercise programme. CXR score: Brasfield score (/25) Disease score: Schwachman score (/100) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were allocated to the home exercise programme group or control group using "computerised random number assignment" which was performed by a statistician. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants and personnel aware of group allocation, the nature of the intervention would make this type of blinding difficult. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lung function outcome measure performed by blinded assessor. Unclear whether exercise capacity outcome performed by blinded assessor. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropouts accounted for (n = 7). Pulmonary function results available for all participants ‐ indicating similar results with intention to treat analysis as those presented. Only results of participants who completed 2‐years follow up presented (n = 65). |
Selective reporting (reporting bias) | Unclear risk | Physical, exercise and pulmonary function parameters presented as annual rates of change. All outcome measures reported. |
Other bias | Low risk | None identified. |