Windsor 2004.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 66; 33 to the exercise group and 33 to the control group Study start and stop dates: December 2001 to December 2002 Length of intervention: to end of radiation therapy Length of follow‐up: 4 weeks' post‐treatment |
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Participants | Type cancer: prostate cancer; 51 of 65 patients had tumors classified as T1 to T2 Time since cancer diagnosis: not reported Time in active treatment: not begun 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: not reported On hormone therapy, receiving adjuvant hormone therapy for high‐risk tumors, n (%):
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Interventions | 33 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of the experimental exercise intervention: target HR of 60% to 70% calculated maximum HR Frequency: 3 days per week Duration of individual sessions: 30 minutes Duration of exercise program: to end of therapy Total number of exercise sessions: varied Format: individual Facility: home Professionally led: unclear Adherence: all patients in the exercise group recorded at least 1.5 hours of aerobic exercise at the recommended percentage maximum HR per week throughout radiation therapy 33 participants assigned to control group, including:
Contamination of control group: none, the control group showed a small, nonsignificant decline in hours of reported aerobic activity per week during radiation therapy |
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Outcomes | No primary outcome was identified. Outcomes included:
Outcomes were measured at baseline; after 5, 10, 15, and 20 fractions of radiation therapy; and at follow‐up 4 weeks after the completion of treatment:
Subgroup analysis: none Adverse events: none reported |
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Notes | Country: UK 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) | Low risk | "Patients were randomized to trial group by telephone call to the Scottish Cancer Therapy Network randomization line…" |
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 | High risk | 1 participant in the exercise group withdrew and was not included in the analysis |
Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcomes |
Other bias | High risk | Baseline tests performed after randomization |