Segal 2003.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 155; 82 to the exercise group and 73 to the control group Study start and stop dates: September 1999 to August 2001 Length of intervention: 12 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: prostate cancer Stage, n (%):
Time since cancer diagnosis, mean (SD) days:
Time in active treatment: "scheduled to receive androgen deprivation therapy" 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; prior activity level, n (%):
On hormone therapy: not reported |
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Interventions | 82 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): anaerobic Intensity of the experimental exercise intervention: at 60% to 70% of 1‐repetition maximum, increasing resistance by 5 lb when > 12 repetitions Frequency: 3 times per week Duration of individual sessions: as needed to complete program Duration of exercise program: 12 weeks Total number of exercise sessions: 36 sessions Format: individual Facility: fitness center Professionally led by a certified fitness consultant Adherence: attendance averaged 79% (28 of 36 sessions) 73 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 and end of the intervention:
Subgroup analysis:
Adverse events: none reported |
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Notes | Country: Canada Funding: NCIC. CCS; Heart and Stroke Foundation of Canada; Canadian Institutes of Health Research CCS/NCIC Sociobehavioral Cancer Research Network. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Table of random numbers |
Allocation concealment (selection bias) | Low risk | "The treatment allocation was concealed from the study coordinator until completion of baseline testing and stratification" |
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 | Study personnel and outcome assessors for the HRQoL outcomes were not masked or blinded to the study interventions. However, blinding was used for physical outcomes "A research assistant with no knowledge of group assignment collected muscular fitness and anthropometric data and scored questionnaire responses" |
Incomplete outcome data (attrition bias) All outcomes | High risk | 8 men in the exercise group and 12 in the control group withdrew |
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 |