Cadmus 2009.

Methods	Study design: single‐centre RCT Number randomised for 6‐month study: 75; to intervention; 37, to control, 38 Number randomised for 12‐month study: 50; to intervention, 25; to control, 25 Study start: March 2004; stop date: July 2006 Length of intervention: 6 months; subsample study: 12 months Length of follow‐up: to end of intervention Country: USA
Participants	Age, years (mean SD): Intervention: 56.5 (9.5) Control: 55.1 (7.7) Stage, n (%): Intervention: in situ, 4 (11); stage I, 20 (54); stage II, 10 (27), stage IIIA, 3 (8) Control: in situ, 4 (11); stage I, 10 (27); stage II, 18 (46), stage IIIA, 6 (16) Inclusion criteria: • Postmenopausal women • Ages 40 to 75 years • Stage 0‐IIIA breast cancer • 1 to 10 years post diagnosis • ≥ 12 months post completion of adjuvant treatment • Physically able to exercise and physician consent to begin an exercise programme • Sedentary activity pattern (< 60 minutes/week) Exclusion criteria: • Diagnosis of recurrent or other primary cancer event • Current smoker • Diabetes mellitus • Current or planned enrolment in a structured weight loss programme
Interventions	37 participants assigned to exercise intervention: Exercise intervention consisted of a combined supervised training programme at a local health club and a home aerobic training programme. Participants exercised at the health club during designated sessions 3 times per week and were instructed to exercise 2 days/week on their own, either at the health club or at home. Intervention consisted primarily of walking, although participants could choose to meet the exercise goal through other forms of aerobic activity. Participants were asked to perform three 15‐minute sessions during week 1, building to five 30‐minute moderate‐intensity sessions by week 5. Exercise started at 50% of predicted maximal heart rate (220‐age) and was gradually increased to approximately 60% to 80% of predicted maximal heart rate. Adherence: Exercise group participants averaged 123 minutes/week (SD 52) of moderate‐to‐vigorous‐intensity sports/recreational activity (range 0 to 637) 34% of exercisers met the study goal of 150 minutes/week 56% completed at least 120 minutes/week (80% of the study goal) 67% attended supervised exercise sessions 96% reported exercising at least twice per week at home 38 participants assigned to control: Control groups were told that they could exercise on their own if they chose, but that the study’s physical activity programme would not be available to them. They received all exercise programme materials at 6‐month follow‐up. Participants in both groups were also asked not to make significant changes in their dietary habits.
Outcomes	Outcomes: Happiness assessed by the 2‐item Fordyce Happiness Measure Self‐esteem assessed on the Rosenberg Self‐Esteem (RSE) Scale Depression assessed via the Centers for Epidemiological Studies—Depression Scale (CES‐D) Anxiety assessed by the State‐Trait Anxiety Index (STAI) Stress assessed on Cohen’s 10‐Item Perceived Stress Scale Quality of life (QoL) assessed by FACT‐B and Medical Outcomes 36‐Item Short Form Health Survey (MOS SF‐36) Physical activity assessed via a 7‐day physical activity log (PAL) and daily steps recorded on a 7‐day pedometer log Anthropometric measurements including body weight, body mass index (BMI), total percent body fat, and lean mass obtained with whole‐body dual‐energy X‐ray absorptiometry (DEXA) Bone mineral density and bone mineral content via DEXA Waist and hip circumferences Insulin and plasma concentrations of total insulin‐like growth factor‐1 (IGF‐1) and insulin‐like growth factor binding protein‐3 (IGFBP‐3) measured in serum with an enzyme‐linked immunosorbent assay (ELISA) kit Systolic and diastolic blood pressure (available for 65 participants) Metabolic variable assays, fasting high‐density lipoprotein (HDL‐C), triglycerides, blood glucose (all enzymatically measured via Alfa Wassermann ACE Alera Chemistry Analyzer with reagents supplied by the company), and metabolic syndrome z‐score (all outcomes available for 65 participants) Numbers of participants assessed: Intervention: baseline, 37 (35 for metabolic variable assays); at 6 months, 37 (35 for metabolic variable assays) Control: baseline, 38 (30 for metabolic variable assays); at 6 months, 37 (30 for metabolic variable assays) Adverse events: none reported
Notes	Trial registration link: none available Trial authors contacted: no Intention‐to‐treat analysis: yes but last observation carried forward (LOCF) Funding: Lance Armstrong Foundation, American Cancer Society, Susan G. Komen. In part by the National Center of Research Resources (NIH)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random number generator was used.
Allocation concealment (selection bias)	Low risk	“The randomization code for each participant was obtained by the principal investigator (who was not involved in recruitment or data collection) only after baseline measures for that individual had been completed and staff conducting clinic visits did not have access to the randomization program”.
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	Low risk	Study personnel and outcome assessors were not masked or blinded to study interventions.
Incomplete outcome data (attrition bias) All outcomes	High risk	Last observation carried forward (LOCF) approach was used; “baseline QoL values were carried forward”.
Selective reporting (reporting bias)	Low risk	No selective reporting of outcomes is apparent.
Other bias	Low risk	Trial appears to be free of other problems that could put it at high risk of bias.