Vadiraja 2009b.

Study characteristics
Methods	Study design: RCT Number randomized: 88; 44 to the exercise group and to 44 the control group Study start and stop dates: participants were recruited over a 2‐year period from January 2004 to June 2006 Length of intervention: 6 weeks Length of follow‐up: to end of the intervention
Participants	Type cancer: breast cancer Cancer stage, n (%): exercise group: Stage I, 2 (4.5%); Stage II, 11 (25.0%); Stage III, 31 (70.5%) control group: Stage I, 3 (6.8%); Stage II, 7 (15.9%); Stage III, 34 (77.3%) Time since cancer diagnosis: not reported Time in active treatment: prescribed adjuvant radiation therapy with a cumulative dose of 50.4 Gy with fractionations spread over 6 weeks Inclusion criteria: women with recently diagnosed operable breast cancer 30 to 70 years old Zubrod's performance status 0 to 2 (ambulatory > 50% of time) had high‐school education provided written consent to participate in the study Eligibility criteria related to interest or ability, or both, to exercise: none Exclusion criteria: had any concurrent medical condition that was likely to interfere with the treatment had major psychiatric, neurologic illness, or autoimmune disorder had any known metastases Gender: female Current age, mean (SD) years exercise group: 46.7 (9.3) years control group: 48.5 (10.2) years Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level: not reported SES: 94.2% of participants were in "middle class" and remainder were in "upper middle class" Employment status: not reported Comorbidities: not reported Past exercise history: 9% of population had previous exposure to yoga On hormone therapy: not reported
Interventions	44 participants assigned to the exercise intervention, including: a set of asanas (postures done with awareness) breathing exercises pranayama (voluntarily regulated nostril breathing) meditation yogic relaxation techniques with imagery (mind‐sound resonance technique and cyclic meditation) Type exercise (aerobic/anaerobic): aerobic Intensity of the experimental exercise intervention: not reported Frequency: at last 3 sessions 1 hour per week  and asked to practice daily at home Duration of individual sessions: 60 minutes Duration of exercise program: 6 weeks Total number of exercise sessions: at least 18 sessions Format: individual Facility: facility and home Professionally led: professionally led by a trained yoga therapist Adherence: adherence to intervention was: 29.7% attended 10 to 20 supervised sessions, 56.7% attended 20 to 25 supervised sessions, and 13.7% attended > 25 supervised sessions over a 6‐week period 44 participants assigned to control group, including: brief supportive therapy with education as a component Contamination of control group: not reported
Outcomes	No primary outcome was identified. Outcomes included: positive and negative affect, assessed using the PANAS global HRQoL, assessed using the EORTC Quality of Life C30 and subscales physical function role function emotional function cognitive function social function fatigue pain insomnia Psychological distress, assessed using the Rotterdam Symptom Checklist and subscales psychological distress physical distress impairment in activities of daily living depression, measured using the HADS anxiety, measured using the HADS perceived stress, measured using the Perceived Stress scale physical outcomes included cortisol levels Outcomes were measured at baseline and 6 weeks: exercise group: n = 44 at baseline, n = 42 at 6 weeks control group: n = 44 at baseline, n = 33 at 6 weeks Subgroup analysis: none Adverse events: not reported
Notes	Country: India Funding: Central Council for Research in Yoga and Naturopathy, Ministry of Health and Family Welfare, Government of India
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Allocation sequence was generated using computer‐generated computer numbers
Allocation concealment (selection bias)	Low risk	Randomization was performed using opaque sequentially numbered envelopes
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	Analyses were conducted on an ITT basis, which accounted for the substantial attrition from the trial, especially in the control arm
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