Targ 2002.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 181; 93 to the exercise group and 88 to the control group Study start and stop dates: not reported Length of intervention: 12 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: breast cancer, Stage, n (%)
Time since cancer diagnosis: within 18 months of diagnosis Time beyond active treatment: not reported, but some women were on chemotherapy, n (%):
Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both: none reported Exclusion criteria: none reported Gender: female Current age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity/race, n (%):
Education level, n (%):
SES, income, n (%):
Employment status: not reported Comorbidities: not reported Past exercise history, number of days spent exercising and minutes of exercise, mean (SD) days and minutes:
On hormone therapy, n (%):
Postmenopausal status, n (%):
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Interventions | 93 participants assigned to an intensive lifestyle change and group support program that included:
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: mild to moderate Frequency: once per week Duration of individual sessions: 90 minutes Duration of exercise program: 12 weeks Total number of exercise sessions: 12 Format: group Facility: facility Professionally led: nurse 88 participants assigned to the control group, including:
Adherence: 6 women did not attend any session, but no other adherence was noted Contamination of control group: not reported |
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Outcomes | Outcomes: QoL outcomes, including:
Outcomes were measured at baseline and at 12 weeks:
Adverse events: none reported |
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Notes | Country: US Funding: United States Department of Defense Material Command |
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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 blind the participants; however, it is unclear whether the outcome was influenced by a lack of masking |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Study personnel and outcome assessors were not masked or blinded to the study interventions |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Although it was stated that an ITT analysis was performed, there were 7 women who dropped out in the intervention group and 24 in the control group and an additional 27 who did not attend any session and 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 |