Pinto 2003.

Methods	Study design: single‐centre RCT Number randomised: 24; 12 to intervention, 12 to control Study start: not reported; stop date: not reported Length of intervention: 12 weeks Length of follow‐up: to end of intervention Country: USA
Participants	Age, years (mean SD): 52.5 (6.8) Stage, n (%): Stage 0, 2 (9); stage I, 18 (78); stage II, 3 (13) Inclusion criteria: • Sedentary women (exercised < 3 times per week for 20 minutes per session) • Received diagnosis of breast cancer (stage 0, I, or II) over the past 3 years • Postsurgery patients who had completed chemotherapy or radiation treatment Exclusion criteria: • Medical or current psychiatric illness that would make compliance with the study protocol difficult or dangerous (e.g. coronary artery disease, hypertension, diabetes) • Orthopaedic problems or neuropathies that would limit exercise training • Medications that would alter training responses (e.g. beta‐blockers) or affect distress outcomes (e.g. antidepressants)
Interventions	12 participants assigned to exercise intervention: Following exercise tolerance test, the supervised exercise intervention group was taught basic exercise principles and techniques (e.g. stretching techniques, warm‐up/cool‐down). Exercise session developed into 10 minutes of warm‐up (cardiovascular and flexibility), 10 minutes of cool‐down (cardiovascular and flexibility), and 30 minutes of cardiovascular activity in one’s target heart rate zone (60% to 70% of peak heart rate by the end of the 12‐week intervention). Cardiovascular activities included treadmill walking, arm and leg ergometers, arm cycling, stationary cycling, and rowing. Participants used at least 3 modes of physical activity per session that would ensure at least 1 cardiovascular arm activity. During the last month, participants performed strength training with light weights (1‐ to 5‐lb handheld weights) for the triceps, biceps, pectoral muscles, shoulders, and upper back, and stomach crunches; these muscle endurance exercises were offered to improve upper body endurance. The total duration of sessions was 50 minutes. Also, participants were given instructions for exercising at home and were encouraged to start to exercise on their own at least once a week. Adherence: Three participants withdrew; the remaining 9 participants completed 88% of the 36 sessions. 12 participants assigned to control: Wait‐list control group Asked not to change current level of physical activity for 12 weeks On completion of assessments, participants were offered the exercise programme free of charge
Outcomes	Outcomes: Peak workload, exercise time, blood pressure, heart rate, and rate pressure product were assessed during a peak graded exercise stress test on a cycle ergometer (post‐test included only exercise group participants). POMS, a 65‐item questionnaire, measures a variety of mood states including anger, tension/anxiety, depression, vigour, fatigue, confusion, and total mood disturbance; vigour and total mood score were used as primary outcomes in this study. Response options are presented on a scale of 0 to 4 (0 = not at all, 4 = extremely). BES, a 35‐item scale, assesses a participant's evaluation of sexual attractiveness, weight concerns, and physical condition with 3 subscales, on which higher scores indicate higher esteem. Positive and Negative Affect Scale (PANAS) was used to assess the participant's positive and negative affect. Each of the 20 items on the PANAS required a response to "how you are feeling at the moment?" on a 1 to 5 Likert scale (1 = very slightly, 5 = extremely). Numbers of participants assessed: Intervention: baseline, 12; after intervention, 9 Control: baseline, 12; after intervention, 6 Nine participants in the intervention group completed exercise stress tests post intervention; 3 participants in this group withdrew but provided postintervention questionnaire data. Adverse events: not reported
Notes	Trial registration link: none available Trial authors contacted: no Intention‐to‐treat analysis: no Funding: National Institute of Mental Health
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Generation of the random sequence was not described.
Allocation concealment (selection bias)	Unclear risk	Whether 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 conceal allocation to the intervention from participants.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Study personnel and outcome assessors were not masked or blinded to study interventions.
Incomplete outcome data (attrition bias) All outcomes	High risk	Postintervention exercise stress test and weight data were unavailable for the control group, and postintervention mood and self‐esteem data were available for only half of the control group. Six (50%) control participants were not included in the analyses.
Selective reporting (reporting bias)	Low risk	No selective reporting of outcomes is apparent.
Other bias	High risk	Small sample size was further hampered by a high dropout rate, particularly in the control group (50%).