Segar 1998.
Study characteristics | ||
Methods | Study design: quasi‐randomized partial cross‐over controlled trial. We include only the first treatment period Number randomized: 30; 10 to an exercise group, 10 to an exercise and behavioral modification group, and 10 to a control group. The exercise and exercise and behavioral modification groups were combined for all analyses Study start and stop dates: not reported Length of intervention: 10 weeks Length of follow‐up: 12 weeks |
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Participants | Type cancer: breast cancer Time since cancer diagnosis: not reported Time beyond active treatment, mean (SD, range) months: 41.8 (24.9, 1 to 99) months Time since surgery, mean (SD, range) months:
Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both:
Exclusion criteria:
Gender: female Current age, mean (SD, range) years:
Age at cancer diagnosis: not reported Ethnicity/race:
Education level:
SES: not reported Employment status:
Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported |
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Interventions | 10 participants assigned to the exercise group, including
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: ≥ 60% of age‐predicted maximum HR (mild to moderate) Frequency: 4 days per week Duration of session: 30 to 40 minutes per session Duration of program: 10 weeks Total number of exercise sessions: 40 Format: unclear Facility: exercise facility was at the university or that of the participants' preference Professionally led: not professionally led 10 participants assigned to the exercise and behavioral modification group, including:
Adherence: overall compliance, assessed from self‐reported exercise logs averaged 1363 (SD = 577) minutes over the 10 weeks, where 100% compliance is equivalent to 1,200 minutes. Average compliance for participants reaching at least 89% compliance was 1532 (SD = 103) minutes (mean compliance of 130%) with a range form 89 to 250% 10 participants initially assigned to the control group, including:
Contamination of control group: unclear |
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Outcomes | Outcomes: QoL outcomes, including:
Outcomes were measured at baseline and at 10 weeks:
Adverse events: none reported |
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Notes | Country: US Funding: Michigan Initiative for Women's Health Grant |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "Subjects were rotated sequentially into two treatment conditions and one control group" |
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 | High risk | 4 participants were excluded from the exercise group and 2 participants were excluded from the control group. Exclusion from the analyses occurred because of attrition or noncompliance with the study protocol |
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 |