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. 2016 Sep 21;2016(9):CD005001. doi: 10.1002/14651858.CD005001.pub3

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
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
Outcomes
  • Nausea: Symptom Checklist 90 Revised (SCL‐90‐R)

  • Somatisation: SCL‐90‐R


Outcomes measured at baseline and end of intervention
Notes Funding: Not reported
Conflict of interest: Not reported
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