Culos‐Reed 2010.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 100; 53 to the exercise group and 47 to the control group Study start and stop dates: recruitment occurred between 2004 and 2006 Length of intervention: 16 weeks Length of follow‐up: 12 months |
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Participants | Type cancer: prostate cancer Time since cancer diagnosis: not reported Time in active treatment: not reported Inclusion criteria:
Eligibility criteria related to interest or ability, or both, to exercise:
Exclusion criteria:
Gender: male Current age, mean (SD, range) years:
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level, n (%):
SES, annual income, n (%):
Employment status, n (%):
Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported |
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Interventions | 53 participants assigned to the individualized physical activity exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of the experimental exercise intervention: moderate Frequency:
Duration of individual sessions:
Duration of exercise program: 16 weeks Total number of exercise sessions:
Format: individual and group Facility: home and facility (fitness center) Group‐based component professionally led by certified fitness professional Adherence: not reported 47 participants assigned to control group, including:
Contamination of control group: not reported |
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Outcomes | Primary outcome:
Other outcomes included:
Outcomes were measured at baseline, 16 weeks, 6 months, and 12 months:
Subgroup analysis: not reported Adverse events: not reported |
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Notes | Country: Canada Funding: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The generation of the random sequence was not described |
Allocation concealment (selection bias) | Unclear risk | Whether the treatment assigned 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 | Allocation to the intervention was not concealed from the study personnel |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Analyses were conducted on an ITT basis |
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 |