Pinto 2005.

Study characteristics
Methods	Study design: RCT Number randomized: 86; 43 to the exercise group and 43 to the control group Study start and stop dates: 1998 to 2003 Length of intervention: 12 weeks Length of follow‐up: 12 weeks, 6 months, and 9 months
Participants	Type cancer: breast cancer Cancer stage, Stage 0 to II, n (5): exercise group: Stage 0, 8 (18.6%); Stage I, 17 (39.5%); Stage II, 18 (41.9%) control group: Stage 0, 6 (14.0%); Stage I, 15 (34.9%); Stage II, 22 (51.2%) Time since cancer diagnosis, mean (SD) years: exercise group: 1.74 (1.49) years control group: 1.93 (1.37) years) Time beyond active treatment: not reported Inclusion criteria: ≥ 18 years old diagnosed with Stage 0 to II breast cancer over the last 5 years completed surgery, chemotherapy, radiation therapy, or a combination ambulatory (able to walk 1 mile without assistive devices) willing to be randomized Eligibility criterion related to interest or ability to exercise, or both: currently sedentary (exercised < once a week for 20 minutes at vigorous intensity or < twice a week for 30 minutes at moderate intensity for the past 6 months) Exclusion criteria: prior history of cancer, except for nonmelanoma skin cancer medical or current psychiatric illness making compliance with the study protocol difficult or dangerous cardiovascular disease, diabetes, or orthopedic problems that would limit exercise training Gender: female Current age, mean (SD) years: exercise group: 53.42 (9.08) years control group: 52.86 (10.38) years Age at cancer diagnosis: not reported Ethnicity/race, n (%): exercise group: white, 42 (97.7%); African‐American, 0 (0%); Native American, 0 (0%); Asian/Pacific Islander, 0 (0%) control group: white, 40 (93.0%); African‐American, 1 (2.3%); Native American, 1 (2.3%); Asian/Pacific Islander, 1 (2.3%) Education level, n (%): exercise group: high school diploma, 7 (16.3%); vocational/trade school, 1 (2.3%); some college, 7 (16.3%); Associates degree, 6 (14.0%); Bachelors degree, 11 (25.6%); graduate school, 11 (25.6%) control group: high school diploma, 8 (18.6%); vocational/trade school, 0 (0%); some college, 17 (39.5%); Associates degree, 7 (16.3%); Bachelors degree, 5 (11.6%); graduate school, 6 (14.0%) SES, household income, n (%): exercise group: ≤ USD29,999, 0 (0%); USD30,000 to USD49,999, 11 (25.6%); ≥ USD50,000, 27 (62.8%) control group: ≤ USD29,999, 12 (28.0%); USD30,000 to USD49,999, 5 (11.7%); ≥ USD50,000, 24 (55.8%) Employment status, n (%): exercise group: employed full time, 23 (53.5%); employed part time, 12 (27.9%; retired/homemaker/medical leave, 8 (18.6%) control group: employed full time, 24 (55.8%), employed part time, 4 (9.3%), retired/homemaker/medical leave, 15 (34.9%) Other, BMI, mean (SD) kg/m2: exercise group: 27.5 (5.04) kg/m2 control group: 28.56 (5.50) kg/m2 Comorbidities: none reported Past exercise history: not reported On hormone therapy, n (%): exercise group: 21 (48.8%) control group: 32 (74.4%)
Interventions	43 participants assigned to the exercise group, including: 12‐week, home‐based physical activity program, including brisk walking, biking, swimming, or use of home exercise equipment in‐person instruction on exercising weekly physical activity counseling via telephone, including individually based reinforcement, problem‐solving, and monitoring participation weekly tip sheets on physical activity cancer survivorship tip sheet Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: 55% to 65% of maximum HR Frequency: 10 minutes each on 2 days per week, gradually increased to 30 minutes per day on 5 days per week Duration of sessions: 10 to 30 minutes Duration of program: 12 weeks Total number of exercise sessions: 24 to 60 Format: individual Facility: home‐based Professionally led: unclear; individual instruction provided but not reported by whom and regular telephone calls made, but not reported who made the calls Adherence: participants wore a pedometer, but adherence not reported Control group: 43 participants assigned to control group, including: no change in current level of physical activity for 12 weeks. phone calls from research staff cancer survivor tip worksheet Contamination of control group: not reported
Outcomes	Primary outcome: QoL outcomes, including: POMS, a 65‐item questionnaire, measures a variety of mood states including anger, tension/anxiety, depression, vigor, fatigue, confusion, and total mood disturbance: vigor and total mood score used as primary outcomes in this study. Response options are presented on a scale of 0 to 4 (0 = not at all, 4 = extremely) level of fatigue, assessed by asking participants to place a vertical mark on a 10‐cm linear analog scale.  The scale was scored by measuring the distance in millimeters from the left anchor (i.e., "0") to the vertical mark. Higher scores represent greater fatigue Secondary outcomes: QoL and physiologic outcomes, including: BES, a 35‐item scale assessing a subject's evaluation of sexual attractiveness, weight concerns, and physical condition with 3 subscales, where higher scores indicate higher esteem Physical Activity Recall, assessed by standardized self‐report interview Rockport 1‐mile walk test, with time to walk 1 mile measured All outcomes measured at baseline and end of intervention: exercise group: n = 43 at baseline, n = 39 after intervention control group: n = 43 at baseline, n = 43 after intervention Subgroups: baseline demographics, hormone therapy, type partner controlled for in the analyses. Employment and education dichotomized outcomes Adverse events: not reported
Notes	Country: US Funding: National Cancer Institute grant
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	4 participants withdrew from the exercise group, and 2 participants withdrew from the control group before the 6‐month assessment. Another 2 participants in the control group withdrew before the 9 month assessment
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