Raghavendra 2007.

Study characteristics
Methods	Study design: RCT Number randomized: 98; 45 to the exercise group and 53 to the control group, but this substudy only included 65 participants who began chemotherapy, 31 to the exercise group, and 34 to the control group Study start and stop dates: participants were recruited between January 2000 and June 2002 Length of intervention: varied, based on the number (4 to 8) of adjuvant chemotherapy cycles prescribed following surgery Length of follow‐up: to end of the intervention
Participants	Type cancer: breast cancer Stage, n (%): exercise group: Stage II, 16 (57.1%); Stage III, 12 (42.9%) control group: Stage II, 14 (41.1%); Stage III, 20 (58.8%) Time since cancer diagnosis: not reported Time in active treatment; number of chemotherapy cycles, n (%): exercise group: 6 cycles, 22 (78.6%); 8 cycles, 3 (10.7%); 4 cycles, 3 (10.7%) control group: 6 cycles, 27 (79.4%); 8 cycles, 4 (11.8%); 4 cycles, 3 (8.8%) Inclusion criteria: recently diagnosed operable breast cancer 30 to 70 years old Zubrod's performance status 0 to 2 (ambulatory > 50% of time) high‐school education having a treatment plan with surgery followed by adjuvant chemotherapy or by both adjuvant radiation therapy and chemotherapy consenting to participate in the trial Eligibility criteria related to interest or ability, or both, to exercise: none Exclusion criteria: any concurrent medical condition that was likely to interfere with the treatment major psychiatric, neurologic illness, or autoimmune disorders any known metastases history of intestinal obstruction sensitivity to any class of antiemetics (such as 5HT3 receptor antagonists or dopamine antagonists) and corticosteroids (such as dexamethasone) Gender: female Current age: not reported Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level, mean (SD) years of education: exercise group: 10.4 (5) years control group: 13.5 (3) years SES: not reported Employment status: not reported Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported
Interventions	28 participants assigned to the exercise intervention, including: an integrated yoga program tailored to the participant's need during chemotherapy, consisting of a set of asanas (postures done with awareness) breathing exercises, meditation, and yogic relaxation techniques during chemotherapy infusion, the exercise program consisted of yogic relaxation, meditation using breath awareness, and impulses of touch emanating from palms and fingers, or chanting a mantra the home sessions consisted of yoga postures, breathing exercises and pranayama, and yogic relaxation Type exercise (aerobic/anaerobic): aerobic Intensity of the experimental exercise intervention: not reported Frequency: 6 days per week at home Duration of individual sessions: 1 hour per day at home Duration of exercise program: varied Total number of exercise sessions: unclear Format: individual Facility: clinic and home based Professionally led by a yoga expert in the clinic Adherence: not reported 34 participants assigned to control group, including: psychodynamic supportive‐expressive therapy with coping preparation Originally 53 participants assigned, but only 34 were eligible for this substudy Contamination of control group: not reported
Outcomes	Primary outcomes included: nausea and vomiting, assessed as frequency and intensity of both postchemotherapy and anticipatory nausea and vomiting using the MANE questionnaire Other outcomes included: anxiety state and trait, assessed using the STAI depression, assessed using the BDI global HRQoL, assessed using the FLIC subjective symptoms, assessed using a subjective symptom checklist to measure treatment‐related side effects, problems with sexuality and image, and relevant psychological and somatic symptoms treatment‐related toxicity and side effects, assessed using the WHO Toxicity Criteria during chemotherapy Outcomes were measured at baseline (before starting chemotherapy), mid‐cycle, and at the end of chemotherapy: exercise group: n = 28 before starting the first chemotherapy infusion cycle, n = 28 during the mid‐chemotherapy infusion cycle, n = 28 after completion of the chemotherapy infusion cycle control group: n = 34 before starting the first chemotherapy infusion cycle, n = 34 during the mid‐chemotherapy infusion cycle, n = 34 after completion of the chemotherapy infusion cycle 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 random numbers generated by a random number table
Allocation concealment (selection bias)	Low risk	Treatment assigned was concealed from study personnel using opaque envelopes, which were opened sequentially in the order of assignment during recruitment, with the names and registration numbers of the participants written on the covers
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	Analyses were not conducted on an ITT basis and the treatment of missing data was not described Although no study participants were excluded after the substudy began, it is unclear whether additional study participants could have been included in the substudy
Selective reporting (reporting bias)	Low risk	There appears to be no selective reporting of outcomes
Other bias	High risk	The study was completed on a subgroup of the originally randomized study participants. Because a significant proportion of the originally randomized study participants were not included in the substudy, it is unclear if the selection bias prevented by randomization was maintained