Mock 2004.
Methods | RCT, 2 groups Study start and stop dates: Potential participants were identified between 1998 and 2001 Length of intervention: 6 weeks to 6 months, depending on the duration of the adjuvant therapy Length of follow‐up: end of intervention |
|
Participants | 119 breast cancer patients, stages 0 to III, after surgery, receiving chemotherapy or radiotherapy, sedentary | |
Interventions | Intervention (n = 60): aerobic training (walking), self directed, 50% to 70% HRmax, 15 min per session, increased to 30 min as training progressed, 5 to 6/x week. Radiotherapy: 6 weeks exercise; chemotherapy: 3 to 6 months exercise. Control (n = 59): usual care |
|
Outcomes |
Outcomes measured at: baseline and end of the adjuvant therapy/intervention |
|
Notes | Funding: FIRE (Fatigue Initiative in Research and Education) multi‐institutional award from the Oncology Nursing Society Foundation Conflict of interest: Not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
Allocation concealment (selection bias) | Low risk | Consecutively numbered, sealed, opaque envelopes, opened after baseline testing |
Blinding of participants All outcomes | High risk | Not done |
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 | High risk | Self reported items |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐out:
All participants 11/119 (9.2%) Reported both ITT and per‐protocol analysis |
Selective reporting (reporting bias) | Unclear risk | No study protocol published |
Group similarity at baseline | Low risk | No significant differences |
Adherence | High risk | Not adherent: 15/54 (28%). 72% were adherent in the sense of the studies' definition (85% of minimum prescription) |
Contamination | High risk | Contamination: 21/54 (39%) of the control group were exercising |