Segal 2001.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 123; 40 to the home‐based exercise group, 42 to the supervised exercise group, and 41 to the control group Study start and stop dates: not reported Length of intervention: 26 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: breast cancer, Stages I and II Time since cancer diagnosis: not reported Time in active treatment: within 2 weeks Inclusion criteria:
Eligibility criteria related to interest or ability, or both, to exercise:
Exclusion criteria:
Gender: female Current age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level: not reported SES: not reported Employment status: not reported Comorbidities: not reported Past exercise history; "physically active", %:
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Interventions | 40 participants assigned to the home‐based exercise intervention and 40 to the supervised exercise intervention. Both groups included:
The home‐based (self‐directed) exercise group also included:
The supervised exercise group also included:
Type exercise (aerobic/anaerobic): aerobic Intensity of the experimental exercise intervention: 50% to 60% of the predicted maximal oxygen uptake Frequency:
Duration of individual sessions: not reported Duration of exercise program: 26 weeks Total number of exercise sessions: 130 sessions Format: individual Facility: both home and facility Professionally led by an exercise specialist Adherence: not reported 41 participants assigned to control group, including:
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Outcomes | Primary outcome included:
Other outcomes included:
Outcomes were measured at baseline, 13 weeks, and 26 weeks:
Subgroup analysis: treated with chemotherapy versus other treatment Adverse events: none reported |
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Notes | Country: Canada Funding: National Cancer Institute of Canada, CCS |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table |
Allocation concealment (selection bias) | Unclear risk | Whether the treatment assignment was concealed from study personnel and participants was not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Owing to the nature of the intervention, it was not possible to conceal allocation to the intervention from the participants |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Study personnel and outcome assessors were not masked or blinded to the study interventions |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Values carried forward for withdrawals, and withdrawals balanced across groups: home‐based exercise, 7; supervised, 8; control, 7 |
Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcomes |
Other bias | Low risk | The trial appears to be free of other problems that could put it at a high risk of bias |