Daley 2007.

Methods	Study design: single‐centre RCT Number randomised: 108; 34 to exercise therapy, 36 to exercise placebo, 38 to control Study start: January 2003; stop date: July 2005 Length of intervention: 8 weeks Length of follow‐up: at 24 weeks Country: UK
Participants	Age, years (mean SD): Exercise therapy group: 51.6 (8.8) Exercise placebo group: 50.6 (8.7) Control: 51.1 (8.6) Stage: Exercise therapy: not reported Exercise placebo: not reported Control: not reported Inclusion criteria: • Women who were not regularly active • Treated for localised breast cancer 12 to 36 months • Aged 18 to 65 years • Willing to attend supervised exercise sessions 3 times per week for 8 weeks • Exercise pre‐contemplator, contemplator, or preparer as defined by the TTM Exclusion criteria: • Women with metastases • Inoperable or active locoregional disease determined ineligible by clinician • Physical or psychiatric impairment that would seriously influence physical mobility • Nausea, anorexia, or other diseases affecting health • High activity level • Contraindication to exercise, assessed by Physical Activity Readiness
Interventions	34 participants assigned to 8‐week exercise intervention: Supervised one‐to‐one aerobic exercise performed 3 times per week for 50 minutes at moderate intensity (65% to 85% of age‐adjusted HR maximum and RPE of 12 to 13) In addition to exercise therapy, a variety of cognitive‐behavioural techniques for promoting exercise behaviour change were explored with participants during sessions. 36 participants assigned to exercise placebo: Exercise placebo group also attended 24 one‐to‐one 50‐minute sessions during 8 weeks; performed light‐intensity body conditioning/stretching (e.g. flexibility, passive stretching) exercises during which HR was maintained below 40% heart rate reserve (HR typically was kept below 100 beats per minute). No exercise counselling or behavioural change advice was provided; instead, conversations were centred on topics of everyday life (i.e. weather, news items, and families). Participants assigned to exercise placebo were otherwise asked to continue with their lifestyle as normal. Adherence: Attended at least 70% (at least 17 of 24 sessions) of sessions; exercise therapy group, 77%; exercise placebo group, 88.9% 38 participants assigned to control: No activity or education. Usual care group was asked to continue with their lives as usual.
Outcomes	Primary outcomes: FACT‐G FACT‐B Secondary outcomes: Fatigue assessed with Revised PFS Satisfaction with life Depression assessed by BDI‐II Physical Self‐Perception Profile, including five 6‐item subscales: perceived sports competence, attractiveness of body, physical conditioning competence, physical strength competence, and physical self‐worth Physical activity and exercise behaviour assessed by asking participants how often they had participated in 1 or more physical activities for 20 to 30 minutes per session in the past 5 months and by completing the stage of change for exercise ladder (SOC) Aerobic fitness assessed via submaximal 8‐minute single‐stage walking test performed on a treadmill Weight and BMI Body fat assessed by bioelectrical impedance analysis Muscle function assessed by a Bioidex isokinetic machine Numbers of participants assessed: Intervention: baseline, 34; at week 8, 33; at week 24, 31 Exercise placebo: baseline, 36; at week 8, 36; at week 24, 34 Control: baseline, 38; at week 8, 33; at week 24, 31 Adverse events: not reported
Notes	Trial registration link: none available Trial authors contacted: yes, trial authors provided additional outcome data Intention‐to‐treat analysis: unclear Funding: Cancer Research UK (grant number: CE8304)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“performed using stratified random permuted blocks”
Allocation concealment (selection bias)	Low risk	Telephone randomisations service was provided by an independent trials unit.
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	“Outcome assessors were not blinded to participants’ group allocation”.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	“Data were analysed on an ITT basis” It is unclear how this was done.
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.