Winningham 1988.
Methods | RCT, 3 groups Study start and stop dates: not reported Length of intervention: 10 weeks Length of follow‐up: end of intervention |
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Participants | 42 breast cancer patients, after surgery, receiving chemotherapy, within the first 6 months of chemotherapy, but having had at least 3 treatments prior to entering the study program, not on doxorubicin, Karnofsky 60% to 100%. None of the participants received antiemetic medication | |
Interventions | Intervention (n = 16): aerobic training (cycling, interval training), 60% to 85% HRmax, 20 to 30 min per session, 3/week, 10 weeks, supervised Control group 1 (n = 12): no intervention Control group 2 (n = 14): "placebo" mild stretching, conversation, 1/week, supervised |
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Outcomes |
Outcomes measured at baseline and end of intervention |
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Notes | Funding: Not reported 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 as randomised. The generation of the random sequence was not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants All outcomes | High risk | Placebo group Comment: Patients in the placebo group would have been aware that they were not in the exercise group, but in the stretching group |
Blinding of personnel/care providers All outcomes | High risk | Not reported. Comment: probably not done |
Blinding of outcome assessment (detection bias) All outcomes except fitness outcomes | High risk | Self reported items |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were accounted for |
Selective reporting (reporting bias) | High risk | Participants answered all 90 items of the SCL‐90‐R. Hereby, "the investigators hoped to avoid sensitizing patients to awareness of any one symptom". Results for other items apart from nausea and somatisation part were not reported |
Group similarity at baseline | High risk | "similar in age, height and body weight". Participants in control group were higher educated than those in exercise and placebo groups. Placebo group had more married women than exercise and placebo groups. |
Adherence | Unclear risk | Not reported |
Contamination | Unclear risk | Contamination not reported. Inclusion criterion: "not in an exercise program". Control participants were advised to notify project personnel if they began exercising on a regular basis either as part of a group or on their own |