MacVicar 1989.
Methods | RCT, 3 groups, stratified by functional capacity Study start and stop dates: not reported Length of intervention: 10 to 12 weeks Length of follow‐up: end of intervention |
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Participants | 62 breast cancer patients, stage II; after surgery, receiving chemotherapy, entered the study; 45 patients were analysed for cardiorespiratory fitness; 24 patients (without placebo group and further patients excluded) were analysed for weight change and body composition |
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Interventions | Intervention (n = 18): aerobic training (cycling, interval training), 60% to 85% HRmax, 20 to 30 min per session, 3/week Control group 1 (n = 11): flexibility and stretching exercises ("placebo group") Control group 2 (n = 16): no intervention |
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Outcomes |
Outcomes measured at baseline and end of intervention |
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Notes | Funding: National Institutes of Health Grants RO1 NR 01078, National Center for Nursing Research and P 3OCA 16058 14, National Cancer Institute Conflict of interest: Not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stated to be randomised, but method not described |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants All outcomes | High risk | Placebo group analysed for functional capacity did stretching exercises. Comment: participants would have been aware if they were in the exercise group or the stretching group |
Blinding of personnel/care providers All outcomes | High risk | Not reported. Comment: probably not done |
Blinding of outcome assessment (detection bias) Fitness outcomes | High risk | Not reported. Comment: probably not done |
Blinding of outcome assessment (detection bias) All outcomes except fitness outcomes | Unclear risk | No other relevant outcomes |
Incomplete outcome data (attrition bias) All outcomes | High risk | Drop‐out rate for all participants: 17/62 (27.4%) 45 of 62 participants were analysed for functional capacity. Per‐protocol analysis (n = 45) of n = 62, who entered the study |
Selective reporting (reporting bias) | High risk | It is unclear why data for only 2 groups was analysed for weight change and body composition |
Group similarity at baseline | High risk | Educational status differed. Data for 17 women not shown for baseline |
Adherence | Low risk | Adherence complete (missed sessions repeated) |
Contamination | Unclear risk | "No subject participated in any other exercise or rehabilitation program during the 10 week data collection period." Comment: amount of physical activity outside of programs unclear |