Lötzke 2016.
Methods | Randomised controlled trial | |
Participants | Women with diagnosed stage I‐III breast cancer undergoing cytotoxic (neo)adjuvant or endocrine adjuvant treatment Recruited from a University Hospital's Interdisciplinary Breast Center Mean age 51.2 years N = 119 |
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Interventions | • Iyengar yoga (yoga postures, breathing techniques), 12 weeks, once weekly for 20 minutes • Physical exercise, 12 weeks, once weekly for 20 minutes |
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Outcomes | Health‐related quality of life (European Organisation of Research and Treatment of Cancer QLQ‐30) at week 12 and week 24 Fatigue (EORTC QLQ‐C30 Fatigue Symptom Scale; 15‐item Cancer Fatigue Scale (CFS‐D)) at week 12 and week 24 |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Participants were randomized to one of the two intervention groups." No information on procedure of randomisation |
Allocation concealment (selection bias) | Unclear risk | No information on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information on blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "Three patients dropped out at t1 and finally 54 patients at t2 (59%). Reasons could not be documented clearly." Sample size was not large enough to compensate for dropouts. |
Selective reporting (reporting bias) | Low risk | No protocol available but no hint of selective reporting |
Other bias | Unclear risk | "The number of lessons varied from 5 to 12, and the lapse of time, in between the patients performed, varied from 6 weeks to 25 weeks. This variation was not considered in the analysis." Intervention period and compliance unclear |