Danhauer 2009.

Study characteristics
Methods	Study design: RCT Number randomized: 44; 22 to the exercise group and 22 to the control group Study start and stop dates: recruitment from August 2005 to October 2006 Length of intervention: 10 weeks Length of follow‐up: to end of the intervention
Participants	Type cancer: breast cancer, DCIS or stages I to IV Cancer stage, n (%): exercise group: DCIS, 3 (13.6%); Stage I, 5 (22.7%); Stage II, 10 (45.5%); Stage III, 3 (13.6%); Stage IV, 1 (4.6%) control group: DCIS, 5 (22.7%); Stage I, 9 (40.9%); Stage II, 3 (13.6%); Stage III, 2 (9.1%); Stage IV, 3 (13.6%) Time since cancer diagnosis, mean (SD) months: e group: 24.4 (39.5) months control group: 22.8 (35.6) months Time beyond active treatment: 2 to 24 months post primary treatment (surgery); 34% still in active treatment Inclusion criteria: ≥ 18 years old 2 to 24 months post primary treatment (surgery) following initial diagnosis recurrence of breast cancer within the past 24 months (regardless of treatment status) able to understand English Eligibility criterion related to interest or ability to exercise, or both: physically able to attend restorative yoga classes Exclusion criteria:  medical contraindications as reported by physician Gender: women Current age, mean (SD) years: exercise group: 54.3 (9.6) years control group: 57.2 (10.2) years Age at cancer diagnosis: not reported Ethnicity/race, n (%): exercise group: non‐Hispanic white, 19 (86.4%); African‐American, 2 (9.1%); Asian/Pacific Islander, 1 (4.6%) control group: non‐Hispanic white, 20 (90.9%); African‐American, 1 (4.6%); Asian/Pacific Islander, 1 (4.6%) Education level, n (%): exercise group: high school diploma/GED, 0 (0.0%); some college or vocational school, 6 (27.3%); college graduate, 5 (22.7%); graduate study or degree, 1 (50.0%) control group: high school diploma/GED, 3 (13.6%); some college or vocational school, 8 (36.4%); college graduate, 3 (13.6%); graduate study or degree, 8 (36.4%) SES, n (%): exercise group: < USD35,000, 6 (30.0%); USD35,000 to USD49,999, 3 (15.0%); USD50,000 to USD99,999, 8 (40.0%); ≥ USD100,000, 3 (15.0%) control group: < USD35,000, 5 (27.8%); USD35,000 to USD49,999, 1 (5.6%); USD50,000 to USD99,999, 5 (27.8%); ≥ USD100,000, 6 (33.3%) Employment status: not reported Comorbidities: not reported Past exercise history, n (%): exercise group: never had done yoga, 20 (90.9%); no yoga experience in the past year, 20 (90.9%) control group: never had done yoga, 15 (68.2%); no yoga experience in the past year, 18 (81.8%) On hormone therapy: not reported Ongoing treatment, n (%): exercise group: receiving chemotherapy, 8 (36.4%); receiving radiation therapy, 6 (27.3%) control group: receiving chemotherapy, 3 (13.6%); receiving radiation therapy, 3 (13.6%)
Interventions	22 participants assigned to the exercise intervention, including: restorative yoga which combined physical postures (asanas), breathing (pranayama), and deep relaxation (savasana).  Yoga poses were modified based on participant needs. Poses included: mountain pose, arm and shoulder stretch, supported forward fold, seated sun salutation, and reclining twist with a bolster Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of experimental exercise intervention: mild Frequency: once per week Duration of individual sessions: 75 minutes Duration of exercise program: 10 weeks Total number of exercise sessions: 10 Format: group Facility: Wake Forest University Health Sciences and local studio Professionally led by yoga instructor with cancer‐specific yoga training who was registered by the National Yoga Alliance 22 participants assigned to control group, including: usual care waiting list for yoga Adherence: 11 women attended ≥ 7 sessions; 6 women attended 3 to 6 sessions; and 5 women attended ≤ 2 sessions Contamination of control group: not reported
Outcomes	No primary outcomes were identified. Outcomes included: physical health status (PCS and MCS), measured using the MOS SF‐12, which is a 12‐item self‐report measure of perceived health and functioning HRQoL, measured using FACT‐B, which consists of the PWB, SWB, EWB, FWB, and breast cancer‐specific concerns. Overall scores range from 0 to 144, where higher score indicates better HRQoL fatigue, FACT‐F scale, which is a 13‐item 5‐point Likert scale ranging from 0 (not at all) to 4 (very much so), with higher scores indicating lower fatigue levels spirituality, measured using the FACT‐Sp, which has 2 domains, sense of meaning/peace and role of faith, with responses ranging from 1 to 5 on a Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores indicate higher levels of spirituality. Only the sense of meaning/peace subscale was included in this study depression, measured using the CES‐D, which is a 20‐item self‐report measure. Items are rated on a 4‐point scale (0 = rarely or none of the time to 3 = most or all the time) and the total score ranges from 0 to 60. Higher scores indicate greater risk for depression sleep dysfunction, measured using the PSQI, which is a 19‐item self‐report measure positive and negative affect, measured using the PANAS, which is a 20‐item measure. Items are scored on a 5‐point scale with responses ranging from "very slightly or not at all" to "extremely" Outcomes were measured at baseline and 10 weeks (end of the intervention): exercise group: n = 22 at baseline, n = 13 at 10 weeks control group: n = 22 at baseline, n = 14 at 10 weeks Adverse events: cancer recurrence was reported for 4 women in the exercise group and 6 women in the control group. No adverse events were reported
Notes	Country: US Funding: Wake Forest University Comprehensive Cancer Center
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The generation of the random 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 blind the participants; however, it is unclear whether the outcome was influenced by a lack of masking
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	Data were analyzed on an ITT basis. Participants who failed to return the study questionnaire were excluded from the analyses ‐ 9 participants in the exercise group and 7 participants in the control group did not return the study questionnaire. One participant in the control group withdrew from the study
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