Crowley 2003.
Methods | RCT, 2 groups Study start and stop dates: not reported Length of intervention: 13 weeks Length of follow‐up: to the end of the intervention |
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Participants | 22 breast cancer patients, stage I, II; after surgery, receiving adjuvant chemotherapy (doxorubicin (Adriamycin), cyclophosphamide (Cytoxan)), radiation therapy excluded | |
Interventions | Intervention (n = 13): Aerobic training (walking) and resistance training (tubing), self directed, 60% of HRmax, 20 to 60 min per session, 3 to 5 d/week. Resistance training: 12 to 15 repetitions, approximately 20 minutes, 1 to 2 sets, 2 to 3 d/week, 13 weeks. Control (n = 9): Usual care, the same scheduled contact with the nurse researcher as the intervention group during weeks 1, 4, 7, 10, and 13, activity log |
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Outcomes |
Outcomes were measured at:
Adverse events: lymphoedema in 1 participant |
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Notes | Funding: Not reported Conflicts of interest: Not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A random numbers table was utilised prior to the initiation of the study to randomise participants to 1 of the 2 groups. Consecutive numbers on the table were used with numbers ending in an even integer assigned to the exercise group, and numbers ending in an odd integer assigned to the comparison group. Each number was placed in an envelope that was then sealed. The outside of the envelope was then numbered in consecutive order |
Allocation concealment (selection bias) | Unclear risk | Sealed envelope. Comment: it was not mentioned if the envelope was opaque |
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 | Low risk | "The study participant’s group assignment was blinded to the exercise physiologists performing the fitness testing at the week 13 appointment. Study participants were requested to not disclose which study group they had been randomized to." |
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 | Missing data were reported for 2 participants for strength assessment. "A second strength was the adherence by both groups in maintaining activity logs and completing all study measures." |
Selective reporting (reporting bias) | Unclear risk | Detailed results only available for cardiorespiratory fitness |
Group similarity at baseline | Low risk | "The groups were balanced in terms of demographic and disease characteristics." |
Adherence | Unclear risk | The nurse researcher used the logs of both groups to assess adherence to the structured exercise program. Adherence defined as completion of 80% of the individualised targeted endurance and strength exercise, frequency, duration, and intensity. The intervention group walked a mean of 113 minutes per week, as compared to 53 minutes by the comparison group. "The intervention group also demonstrated commitment to following the exercise intervention across the study period." |
Contamination | Unclear risk | The intervention group walked a mean of 113 minutes per week, as compared to 53 minutes by the comparison group. Thus the intervention group was considered to be performing at a moderate level of activity per week, while the comparison group had a low level of activity over the study period. Study participants were asked to commit to not initiating participation in a formal exercise program during the study period. Continuation of an ongoing exercise regimen was acceptable |