Chandwani 2010.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 71, but 10 withdrew leaving 61; 30 to the exercise group and 31 to the control group Study start and stop dates: not reported Length of intervention: 6 weeks Length of follow‐up: 3 months |
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Participants | Type cancer: breast cancer Stage, n (%):
Time since cancer diagnosis: not reported Time in active treatment: not reported Inclusion criteria:
Eligibility criteria related to interest or ability, or both, to exercise:
Exclusion criteria:
Gender: female Current age, mean (SD, range):
Age at cancer diagnosis: not reported Ethnicity/race, n (%):
Education level, n (%):
SES: not reported Employment status, n (%):
Comorbidities: not reported Past exercise history: 4 patients in the exercise and 2 in the control group reported practicing yoga "currently" and 7 in the exercise and 9 in the control group practiced in the past On hormone therapy: not reported |
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Interventions | The number of participants assigned to the exercise intervention was unclear because 10 participants withdrew and their assignment was not reported. Of the remaining participants 30 were assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of the experimental exercise intervention: mild Frequency: twice per week plus encouragement to practice daily at home Duration of individual sessions: 60 minutes Duration of exercise program: 6 weeks Total number of exercise sessions: 12 sessions Format: although designed to be group, the program ended up with most women having 1‐on‐1 sessions Facility: facility with encouragement to practice at home Professionally led by VYASA trained teachers Adherence: 15 participants (50%) attended all 12 classes; 8 (28%) attended 11 classes; and 1 (3%) attended 10 classes. 8 participants (28%) reported practicing yoga outside of class every day, 12 (40%) reported practicing more than twice per week, 8 (28%) reported practicing twice per week, and 1 (3%) reported not practicing outside the classes The number of participants assigned to the control intervention was unclear because 10 participants withdrew and their assignment was not reported. Of the remaining participants 31 were assigned to the control intervention, including:
Contamination of control group: not reported |
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Outcomes | Primary outcome included:
Other outcomes were other subscales of the MOS SF‐36, including:
Outcomes were measured at baseline, 1 week, 1 month, and 3 months:
Subgroup analysis: a number of subgroup analyses are reported for different times and different measures Adverse events: not reported |
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Notes | Country: US Funding: National Cancer Institute, Philanthropic support from the Integrative Medicine Program, The University of Texas M.D. Anderson Cancer Center |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Participants were then randomly assigned… by use of minimization, a form of adaptive randomization" |
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 | Low risk | "An intent‐to‐treat approach was used to analyze the data." The authors used 2 different methods to impute missing data: simple mean imputation and multiple imputation |
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 |