Bower 2011.
| Methods | Study design: single‐centre RCT
Number randomised: 31; 16 to intervention, 15 to control
Study start: March 2007; stop date: July 2010
Length of intervention: 12 weeks
Length of follow‐up: to end of intervention, at 3 months post intervention Country: USA |
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| Participants | Age, years (mean SD):
Stage, n (%):
Inclusion criteria: • Original diagnosis of stage 0‐II breast cancer • Completed local and/or adjuvant cancer therapy (with the exception of hormone therapy) at least 6 months previously • Ages 40 to 65 years • Postmenopausal • No other cancer in the past 5 years • Experiencing persistent cancer‐related fatigue Exclusion criteria: • Chronic medical conditions or regular use of medications associated with fatigue (e.g. untreated hypothyroidism, diabetes, autoimmune disease, anaemia (defined as haematocrit < 24), chronic fatigue syndrome) • Evidence that fatigue was driven primarily by a medical or psychiatric disorder other than cancer (e.g. current major depression, insomnia, sleep apnoea) • Evidence that fatigue was driven primarily by other non‐cancer‐related factors (e.g. shift work, recent change in activity or schedule) • Physical problems or conditions that could make yoga unsafe (e.g. serious neck injury, unstable joints) • Body mass index (BMI) > 31 kg/m² |
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| Interventions | 16 participants assigned to exercise intervention:
• Iyengar yoga, a traditional form of Hatha yoga, performed in groups of 4 to 6 women for 90 minutes twice a week for 12 weeks Adherence: Over 80% of participants attending at least 20 of the 24 yoga classes offered. Mean number of classes attended was 18.9 of 24 classes (78%), and median number was 22 of 24 classes (92%). At 3‐month follow‐up, 9 of 14 women who attended the yoga classes (64%) were continuing to use techniques learned in class. Control group: 15 assigned to control: • Health education classes conducted for 120 minutes once a week for 12 weeks (24 hours) in groups of 4 to 7 women. Classes were led by a PhD‐level psychologist with clinical experience. Adherence: In the education group, the mean number of classes attended was 9.2 of 12 classes (77%), and the median number was 11 of 12 classes (92%). |
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| Outcomes | Primary outcome:
Secondary outcomes:
Numbers of participants assessed:
.Adverse events: none reported |
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| Notes | Trial registration link: none available Trial authors contacted: no Intention‐to‐treat analysis: yes Funding: National Center for Complementary and Alternative Medicine/National Institutes of Health (NCCAM/NIH U01‐AT003682; Iyengar Yoga for Breast Cancer Survivors with Persistent Fatigue) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Allocation sequence was generated independently by the study statistician", but it is unclear how the allocation sequence was generated. |
| Allocation concealment (selection bias) | Unclear risk | "Allocation was concealed in opaque envelopes" but whether "sequential" is not mentioned. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Owing to the nature of the intervention, it was not possible to blind participants; however, it is unclear whether the outcome was influenced by lack of masking. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Outcomes assessors for the performance tasks were blinded to group assignment, and all were trained in standardized testing procedures". |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "All statistical analyses were performed on an intent‐to‐treat basis". Mixed model analysis was used to account for missing data. |
| Selective reporting (reporting bias) | Low risk | No selective reporting of outcomes is apparent. |
| Other bias | Low risk | Trial appears to be free of other problems that could put it at high risk of bias. |