Milne 2008a.
Study characteristics | ||
Methods | Study design: cross‐over RCT. Only information for first period included here Number randomized: 58; 29 to the immediate exercise group and 29 to the delayed exercise control group Study start and stop dates: recruitment between January 2005 and March 2005 Length of intervention: 12 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: breast cancer Cancer stage, n (%):
Time since cancer diagnosis: within 24 months Time beyond active treatment, mean (SD) months:
Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both. Participants were excluded if:
Exclusion criteria:
Gender: female Current age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level, university education, n (%):
SES: not reported Employment status, part‐ or full‐time employment, n (%):
Comorbidities: not reported Past exercise history: not reported On hormone therapy: 74.1% on hormone therapy |
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Interventions | 29 participants assigned to the immediate exercise group, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention:
Frequency: 3 times per week Duration of sessions: 1 hour Duration of program: 12 weeks Total number of exercise sessions: 36 Format: individual and group Facility: Health and Rehabilitation Program Clinic at The University of Western Australia Professionally led: supervised by exercise physiologists Adherence: average attendance was 60.4% (21.7 of 36 sessions) with a median of 23 (63.9%) and a range of 11 to 36 29 participants assigned to the control group, including:
Contamination of control group: not reported |
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Outcomes | Primary outcome: QoL outcomes, including:
Secondary outcomes, included:
Outcomes were measured at baseline, and weeks 6, 12, 18, and 24, except for SFT, which was measured at baseline and 12 weeks only:
Adverse events: none reported |
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Notes | Country: Australia Funding: CCS and the NCIC/CCS Sociobehavioral Cancer Research Network |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization |
Allocation concealment (selection bias) | Low risk | "Group assignments were concealed from the project director who recruited participants to the trial" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Owing to the nature of the intervention, it was not possible to blind the participants; however, it is unclear whether the outcome was influenced by a lack of masking |
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 | All study participants completed week 12 assessments and were included in the analysis |
Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcomes |
Other bias | High risk | Low adherence |