Courneya 2003c.

Study characteristics
Methods	Study design: RCT Number randomized: 53; 25 to the exercise group and 28 to the control group Study start and stop dates: recruitment from May 2001 to June 2001 Length of intervention: 15 weeks Length of follow‐up: to end of the intervention
Participants	Type cancer: breast cancer, n (%) Cancer stage, n (%): exercise group: Stage I, 10 (42%); Stage IIa, 6 (25%); Stage IIb, 6 (25%); Stage IIIa, 2 (8%) control group: Stage I, 11 (39%); Stage IIa, 11 (39%); Stage IIb, 5 (185); Stage IIIa, 1 (4%) Time since cancer diagnosis: not reported Time beyond active treatment: not reported Inclusion criteria: histologically confirmed early‐stage breast cancer diagnosis between January 1999 and June 2000 completed surgery, radiation therapy, chemotherapy, or a combination with or without current hormone therapy use postmenopausal status 50 to 69 years old Eligibility criteria related to interest or ability to exercise, or both: contraindication to exercise on the basis of an exercise stress test Exclusion criteria: evidence of recurrent or progressive disease smoked within previous 12 months non‐English‐speaking not willing to travel to the exercise facility known cardiac disease, uncontrolled hypertension, thyroid disease, diabetes, mental illness, infection, and immune or endocrine abnormality Gender: female Current age, mean (SD) years: exercise: 59 (5) years control: 58 (6) years Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level, n (%) exercise group: 7 (29%) completed university control group: 16 (56%) completed university Household income > USD60,000, n (%): exercise: 10 (44%) control: 13 (48%) Employment status: employed full time, n (%) exercise: 7 (29%) control: 8 (29%) Comorbidities: none reported Past exercise history, mean (SD) minutes: exercise: moderate, 62 (94) minutes; strenuous, 23 (56) minutes; moderate to strenuous, 85 (102) minutes; > 90 moderate to strenuous, 10 (42) minutes control: moderate, 98 (126) minutes; strenuous, 26 (65) minutes; moderate to strenuous, 124 (146) minutes; > 90 moderate to strenuous, 12 (43) minutes On hormone therapy: exercise, 11 (46); control, 13 (46)
Interventions	25 participants assigned to the exercise intervention, including: participants trained on recumbent or upright cycle ergometers Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: 70% to 75% maximal oxygen consumption in untrained subjects Frequency: 3 times per week Duration of sessions: 15 minutes for weeks 1 to 3, then increased by 5 minutes per week to 35 minutes at weeks 13 to 15. A 5‐minute warm‐up and cool‐down period was included Duration of exercise program: 15 weeks Total number of exercise sessions: 45 Format: unclear Facility: facility Professionally led: sessions were supervised by exercise physiologists Adherence: the exercise group completed 98.4% (44.3 of 45) of the prescribed exercise sessions Co‐intervention: none Control group: waiting list Contamination of control group: non–protocol‐related exercise was < 15 minutes of moderate to strenuous exercise per week and was not different between groups
Outcomes	Primary outcomes included: physical outcomes, including change in peak oxygen consumption QoL outcomes, assessed using the FACT‐B scale and the FACT‐G scale Secondary outcomes, included: physiologic outcomes, including peak power output, oxygen consumption, power output at the ventilatory equivalent for oxygen and oxygen consumption and power output for the ventilatory equivalent for carbon dioxide QoL outcomes, including happiness, assessed using the Happiness Measure, self‐esteem assessed using the RSE Scale, and fatigue assessed using FACT‐F physical outcomes, including body weight, BMI, subcutaneous sum of skinfolds Outcomes were measured at baseline and 15 weeks: exercise group: n = 25 at baseline, n = 24 at 15 weeks control group: n = 28 at baseline, n = 26 at 15 weeks Adverse events: exercise group: lymphedema (n = 3), gynecologic complication (n = 1), and influenza (n = 1) control group: foot fracture (n = 1), bronchitis (n = 1)
Notes	Country: Canada Funding: NCIC, CCS, Canadian Institutes of Health Research, Izaak Walton Killiam Memorial Scholarship, Alberta Heritage Foundation for Medical Research studentship
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random‐numbers table
Allocation concealment (selection bias)	Low risk	The allocation sequence and group assignments were generated by a research assistant and then enclosed in sequentially numbered and sealed envelopes. The contents of the envelopes were concealed from the project director, who assigned participants to groups
Blinding of participants and personnel (performance bias) All outcomes	High risk	Owing to the nature of the intervention, masking or blinding of study participants was not possible; however, it is unclear whether the lack of masking could influence the outcomes
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not possible to blind study participants for self‐report measures. Exercise physiologists were blinded for physical outcome measures
Incomplete outcome data (attrition bias) All outcomes	Low risk	1 study participant withdrew from the exercise group and 2 from the control group; they were not included in the physical outcome analyses. The QoL analyses included all but the 1 study participant who had withdrawn from the exercise 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