Pinto 2003.

Study characteristics
Methods	Study design: RCT Number randomized: 24, 12 to the exercise group and 12 to the control group Study start and stop dates: not reported Length of intervention: 12 weeks Length of follow‐up: within 1 week of completing the intervention
Participants	Type cancer: breast cancer, Stage 0 to II Cancer stage, n (%): Stage 0, 2 (9%); Stage I, 18 (78%); Stage II, 3 (13%) Time since cancer diagnosis, mean (SD) days: 452.6 (234.9) days Time beyond active treatment, mean (SD) days: 323.5 (212.3) days Inclusion criteria: diagnosed with Stage 0 to II breast cancer over the past 3 years post‐surgery, had completed chemotherapy, and/or radiation informed consent physician sign‐off agree to be assigned randomly to either of the 2 study groups Eligibility criterion related to interest or ability to exercise, or both: sedentary women (exercised less than 3 times per week for 20 minutes per session)   Exclusion criteria: current medical or psychiatric illness making compliance with protocol difficult or dangerous (e.g. coronary artery disease, hypertension, diabetes) orthopedic problems or neuropathies that would limit exercise training medications likely to alter training responses (e.g. beta‐blockers) or affect distress outcomes (e.g. antidepressants) Gender: female Current age: mean (SD) years, 52.5 (6.8) years Age at cancer diagnosis: not reported Ethnicity/race: 100% Caucasian Education level: high school, 30%; college degree, 30% SES: 42% reported an annual household income of > USD50,000 Employment status: 16 (67%) working full‐time Other: mean (SD) weight was 150.0 (28.2) lbs mean BMI (SD) was 26.8 (4.1) 17 (71%) reported being postmenopausal at baseline Past exercise history: not reported On hormone therapy, n (%): 14 (61%)
Interventions	12 participants assigned to the exercise group, including: 10 minutes of warm‐up (cardiovascular and flexibility), 10 minutes of cool‐down (cardiovascular and flexibility), and 30 minutes of cardiovascular activity in the individual's target HR zone strength (weight) training during final month Type exercise (aerobic/anaerobic): aerobic first 2 months; both aerobic and anaerobic during final month Intensity of experimental exercise intervention: 60% to 70% of peak HR by the end of the 12‐week intervention Frequency: 3 times per week Duration of session: 50 minutes Duration of program: 12 weeks Total number of exercise sessions: 36 Format: group and home‐based exercise program Facility: both facility and home Professionally led: fitness instructor for class, supervised and upgraded program by exercise physiologist once per week Control group: 12 participants assigned to the control group, including waiting list, with no stress tests completed Adherence: 3 participants withdrew within the first 3 weeks Contamination of control group: not reported
Outcomes	Outcome: QoL and physiologic outcomes, including: POMS, a 65‐item measure of 6 mood states including anger, tension, depression, vigor, fatigue, and confusion over the past week, and a summary score (total mood disturbance). Response options ranged between 0 = not at all to 4 = extremely PANAS, which includes 20 items with each requiring a response to 'how you are feeling at the moment?' scored on a 1 to 5 Likert scale (1 = very slightly, 5 = extremely) BES, a 35‐item scale assessing a subject's evaluation of sexual attractiveness, physical condition, and weight concerns. Response options ranged between 1 = have strong negative feelings to 5 = have strong positive feelings BMI weight physical performance on stress test Outcomes were measured at baseline and within 1 week of end of the 12 week training: exercise group: n = 12 at baseline, n = 9 after intervention control group: n = 12 at baseline, n = 6 at 12 weeks for QoL outcomes; physiologic outcomes were not measured at follow‐up Adverse events: none reported
Notes	Country: US Funding: National Institute of Mental Health, NIH
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	3 participants withdrew in the exercise group, and 6 participants withdrew in the control group
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