Mutrie 2007.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 203; 101 to the exercise group and 102 to the control group Study start and stop dates: January 2004 to January 2005 Length of intervention: 12 weeks Length of follow‐up: 6 months |
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Participants | Type cancer: breast cancer Stage, n (%):
Time since cancer diagnosis, mean (SD) days:
Time in active treatment: not reported 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; n (%):
Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported Weight, mean (SD) kg:
BMI, mean (SD)
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Interventions | 101 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of the experimental exercise intervention: moderate; 50% to 75% of age adjusted maximum HR Frequency: 3 times per week Duration of individual sessions: 45 minutes Duration of exercise program: 12 weeks Total number of exercise sessions: 36 sessions Format: 2 group and 1 individual session per week Facility: group session were facility based and individual session home based Professionally led by trained exercise specialists Adherence: not reported 102 participants assigned to control group, including:
Contamination of control group: not reported |
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Outcomes | Primary outcomes included:
Other outcomes included:
Outcomes were measured at baseline, at end of the intervention (12 weeks), and 6 months:
Subgroup analysis: none Adverse events: none reported |
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Notes | Country: UK Funding: Cancer Research UK, UK Medical Research Council |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The randomisation was stratified by hospital and treatment at baseline (chemotherapy, radiotherapy, or combination) and used randomised permuted blocks of length four and six (that is, for sequences of four or six women in each hospital‐treatment combination, exactly half were allocated to each group)" |
Allocation concealment (selection bias) | Low risk | "Randomisation was done by telephone to an interactive voice response system" |
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 | Unclear risk | "We took steps to blind the evaluation of outcomes by having questionnaire responses in sealed envelopes and ensuring that outcome measures were taken by researchers who were not involved in exercise classes" |
Incomplete outcome data (attrition bias) All outcomes | High risk | "We did the analysis on an intention‐to‐treat basis, in the sense that we took no account of adherence to the intervention. We used all available data." However, 19 participants were not included in the analyses at the 12 weeks, including 12 lost to follow‐up (including 2 excluded from the analyses since they were taking tamoxifen) and 7 not assessed. In the control group, 3 participants were lost to follow‐up and 7 not assessed. At the 6‐month time period, 7 were not assessed in the exercise group and 4 in the control group |
Selective reporting (reporting bias) | Low risk | There is no evidence of 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 |