Moadel 2007.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 164; 108 to a yoga exercise group and 56 to the control group Study start and stop dates: 2001 to 2005 Length of intervention: 12 weeks Length of follow‐up: 1, 3, and 6 months |
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Participants | Type cancer: breast cancer, stage of disease:
Time since cancer diagnosis, mean (SD, range) years:
Time in active treatment: receiving chemotherapy, %:
Randomization was stratified by treatment status Inclusion criteria:
Eligibility criterion related to interest or ability, or both, to exercise:
Exclusion criteria: none reported Gender: female Current age, mean (SD, range) years:
Age at cancer diagnosis: not reported Ethnicity/race, %:
Education level:
SES: not reported Employment status: not reported Comorbidities: not reported Past exercise history: not reported On hormone therapy, %:
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Interventions | 108 participants assigned to exercise group, consisting of yoga with each session including:
All exercises were done in a seated or reclined position Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: mild Frequency: once per week, but participants were allowed to attend more than 1 session per week and asked to practice yoga at home Duration of sessions: 90 minutes Duration of program: 12 weeks Total number of exercise sessions: 12 sessions Facility: facility and home Professionally led: not reported 56 participants assigned to control group, including:
Adherence: 26 (31%) participants did not attend any classes, but 8 reported practicing yoga at home at least a few times per week. The mean number of classes attended by active class participants was 7.00 (SD 3.80) classes. Of 59 participants reporting data, 61% practiced yoga at home at least a few times per week Contamination of control group: not reported |
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Outcomes | No primary outcome was identified. QoL outcomes included:
Outcomes were measured at baseline and 12 weeks:
Subgroup analysis: by treatment status Adverse events: none reported |
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Notes | Country: US Funding: National Cancer Institute, Langeloth Foundation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Generation of allocation 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 conceal allocation to the intervention from the participants |
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 | Investigators stated that they used an "intention‐to‐treat approach" but it is unclear how the 24 drop‐outs in the exercise arm and the 12 drop‐outs in the control arm were handled |
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 |