Ohira 2006.
| Study characteristics | ||
| Methods | Study design: RCT Number randomized: 86; 43 to the exercise group and 43 to the delayed exercise control group Study start and stop dates: October 2001 to June 2002 Length of intervention: 6 months Length of follow‐up: to end of the intervention |
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| Participants | Type cancer: breast cancer Cancer stage, n (%):
Time since cancer diagnosis, mean (range) years:
Time beyond active treatment, mean (range) years:
Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both:
Exclusion criteria:
Gender: female Current age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity/race, n (%) Caucasian:
Education level, n (%):
SES: not reported Employment status: not reported Comorbidities: not reported Past exercise history: limited by eligibility criteria On hormone therapy, n (%):
Other: postmenopausal, n (%):
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| Interventions | 43 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of experimental exercise intervention: not reported Frequency: twice per week Duration of sessions: not reported Duration of program: 6 months Total number of exercise sessions: maximum of 52 Format: started as supervised group (4 in a group); after 13 weeks, participants encouraged to work out with buddy(ies). Log sheets checked weekly by fitness trainer and if no data were recorded in 1 week, the fitness trainer called the participant Facility: gym facility Professionally led: certified fitness professional 43 participants assigned to control group, including:
Adherence: baseline to 6 months, 1 participant attended < 80% of the sessions. From months 7 to 12, 14 exercise group participants attended < 70% of sessions Contamination of control group: not reported |
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| Outcomes | Primary outcome: QoL and physiologic outcomes, including:
Outcomes were measured at baseline and 6 months:
Subgroup analyses: post hoc subgroup analyses, including postmenopausal status, baseline levels of sport and leisure physical activity, baseline level of energy intake (kilocalories), and 6‐month changes in physical activity and energy intake Adverse events:
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| Notes | Country: US Setting: Recreation center Funding: Susan G. Komen Foundation and grants to the UMN GCRC from the NIH |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Random number table" |
| Allocation concealment (selection bias) | Low risk | "The randomization procedure used prevented investigators from influencing treatment allocation" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Owing to the nature of the intervention, masking or blinding of study participants was not possible; however, it is unclear whether the lack of masking could influence the outcomes |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Measurement staff remained blinded until the end of the study, with the exception of the strength testing staff..." |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 4 participants lost to follow‐up in the exercise group, 2 due to recurrences and 2 due to withdrawals; 3 participants were lost to follow‐up in the control group, 2 due to recurrences and 1 due to withdrawal |
| 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 |