Bourke 2011.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 50; 25 to the exercise group and 25 to the control group Study start and stop dates: not reported Length of intervention: 12 weeks Length of follow‐up: 6 months |
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Participants | Type cancer: prostate cancer, nonlocalized, with metastatic disease
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) 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, exercise behavior (Godin LSI), mean (SD):
On hormone therapy: all on androgen suppression therapy |
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Interventions | 25 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of the experimental exercise intervention:
Frequency:
Duration of individual sessions: 30 minutes each Duration of exercise program: 12 weeks Total number of exercise sessions: 278 sessions Format: individual; unclear if group "dedicated suite" Facility: facility and home based Professionally led by an exercise physiologist Adherence:
25 participants assigned to control group, including:
Contamination of control group: control group showed activity of 17.4 Godin LSI points at end of intervention (12 weeks) |
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Outcomes | No primary outcome was identified. Outcomes included:
Outcomes were measured at baseline, 12 weeks, and 6 months:
Subgroup analysis: none reported Adverse events: drop‐outs owing to health problems were noted in 4 men in the exercise group (2 because of cardiac issues) and 5 men in the control group |
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Notes | Country: US Funding: none reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization was carried out remotely using nQuery statistical software" |
Allocation concealment (selection bias) | Low risk | " … without disclosure of the sequence to the researcher responsible for the running of the trial until after completion of the baseline assessments" |
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 | "Physiologic and functional fitness outcomes were assessed by a trained technician blinded to group allocation but blinding was not possible for those completing the HRQoL questionnaires" |
Incomplete outcome data (attrition bias) All outcomes | High risk | In the exercise group, 4 participants at 12 weeks and 6 at 6 months were lost to follow‐up. In the control group, 3 at 12 weeks and 9 at 6 months were lost to follow‐up. However, the investigators used the SPSS Expectation Maximization procedure to impute missing values so ITT analyses could be done |
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 |