Griffith 2009.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 138; 73 to the exercise group and 65 to the control group Study start and stop dates: not reported Length of intervention: varied by duration of cancer treatment. For the entire sample, the mean (SD) number of cancer treatment weeks was 12.83 (5.15) with a range of 5 to 35 weeks. The mean (SD) total weeks of cancer treatment was 15.8 (5.89) for nonprostate and 10.44 (2.73) for prostate cancer patients Length of follow‐up: to end of the intervention |
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Participants | Type cancer, n (%): various
Cancer stage, n (%): Stage I, 12 (10%); Stage II, 89 (70%); Stage III, 25 (20%) Time since cancer diagnosis: not reported Time in active treatment: currently undergoing treatment Inclusion criteria:
Eligibility criteria related to interest or ability, or both, to exercise:
Exclusion criteria:
Gender, n (%):
Current age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity/race, n (%):
Education level, n (%):
SES: not reported Employment status, n (%):
Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported\ |
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Interventions | 73 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of the experimental exercise intervention: moderate, corresponding to approximately 50% to 70% of the maximum HR Frequency: 5 times per week Duration of individual sessions: 25 to 35 minutes Duration of exercise program: varied by duration of cancer treatment. For the entire sample, the mean (SD) number of cancer treatment weeks was 12.83 (5.15); range (5 to 35 weeks) Total number of exercise sessions: varied Format: individual Facility: home Not professionally led Adherence, defined as walking at least 60 minutes weekly for more than 2/3 of the total program: 67.6% with an average walking time of 117 (SD = 105) minutes per week 65 participants assigned to control group, including:
Contamination of control group: non‐adherence defined as walking more than 60 minutes for more than 2/3 of treatment weeks. Adherence = 77.6%, and contamination = 22.4% |
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Outcomes | Primary outcome included:
Other outcomes included:
Outcomes were measured at baseline and end of intervention:
Subgroup analysis: examined outcomes by cancer type (prostate versus other cancer) and performed secondary dose‐response analysis, which evaluated outcomes based on the actual amount of exercise performed according to the Physical Activity Questionnaire, regardless of group assignment. This secondary analysis was necessitated by the finding that, contrary to study instructions, 22.4% of the control group participants performed exercise at a level at least equivalent to what was assigned for the exercise group. The subgroup analysis and the secondary analysis were not prespecified Adverse events: not reported |
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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) | Unclear risk | The generation of the random sequence was not described |
Allocation concealment (selection bias) | Unclear risk | Whether the treatment assignment 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 | High risk | Although analyses were conducted on an ITT basis, 5 participants from the intervention arm and 7 from the control arm were not included in the analyses |
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 |