Cadmus 2009.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 75; 37 to the exercise group and 38 to the control group Study start and stop dates: March 2004 to July 2006 Length of intervention: 6 months Length of follow‐up: to end of the intervention |
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Participants | Type cancer: breast cancer, stage 0 to IIIA Time since cancer diagnosis, mean (SD) weeks:
Time beyond active treatment: at least 12 months Inclusion criteria:
Eligibility criteria 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: 84% non‐Hispanic white for both groups Education level:
SES: not reported Employment status: not reported Comorbidities: none Past exercise history, mean (SD):
On hormone therapy:
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Interventions | 37 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of the experimental exercise intervention: Polar HR monitors to maintain the goal of 60% to 80% of predicted maximal HR Frequency: 5 days per week Duration of individual sessions: 30 minutes Duration of exercise program: 6 months Total number of exercise sessions: 120 Format: individual Facility: 2 days/week at home and 3 days/week at a facility (local health club) Professionally led: professionally led by an exercise physiologist Adherence: average 123 minutes/week (SD 52) of moderate to vigorous intensity sports/recreational activity (range: 0 to 637)
38 participants assigned to control group, including:
Contamination of control group: not reported |
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Outcomes | Outcomes: QoL and physiologic outcomes, including:
Outcomes were measured at baseline and 6 months:
Adverse events: none reported |
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Notes | Country: US Funding: Lance Armstrong Foundation, American Cancer Society, Susan G. Komen. In part by the National Center of Research Resources (NIH) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated randomization code |
Allocation concealment (selection bias) | Low risk | "The randomization code was obtained by the principal investigator (who was not involved in recruitment or data collection) only after baseline measures for that individual had been completed and staff conducting clinic visits did not have access to the randomization program" |
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 | Low risk | ITT analysis performed |
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 |