Daley 2007a.

Study characteristics
Methods	Study design: RCT with 3 arms Number randomized: 108; 34 to an exercise‐therapy group, 36 to an exercise‐placebo group, and 38 to a control group Study start and stop dates: January 2003 to July 2005 Length of intervention: 8 weeks Length of follow‐up: 24 weeks
Participants	Type cancer: breast cancer, stage not reported Time since cancer diagnosis: not reported Time beyond active treatment: 12 to 36 months Inclusion criteria: not regularly active treated for localized breast cancer 12 to 36 months previously 18 to 65 years old Eligibility criterion related to interest or ability to exercise, or both: high activity level contraindication to exercise, as assessed using Physical Activity Readiness Questionnaire must be willing to attend supervised exercise sessions 3 times per week for 8 weeks must be an exercise pre‐contemplator, contemplater, or preparer as defined by the TTM Exclusion criteria: presence of metastases inoperable or active locoregional disease as determined by clinician physical or psychiatric impairment that would seriously influence physical mobility suffering from nausea, anorexia, or other diseases affecting health Gender: female Current age: mean (SD) years exercise‐therapy group: 51.6 (8.8) years exercise‐placebo group: 50.6 (8.7) years control group: 51.1 (8.6) years Age at cancer diagnosis: not reported Ethnicity/race: exercise‐therapy group: 34/34 (100%) white exercise‐placebo group: 35/36 (97.2%) white control group: 37/38 (97.4%) white Education level: exercise‐therapy group: secondary and A levels, 17/34 (50.0%); degree, 5/34 (14.7%); other, 12/34 (35.3%) exercise‐placebo group: secondary and A levels, 12/35 (34.3%); degree, 13/35 (37.1%); other, 10/35 (28.5%) control group: secondary and A levels, 18/33 (54.5%); degree, 6/33 (15.2%); other, 9/33 (27.2%) SES: not reported Employment status: employed exercise‐therapy group: 26/34 (76.5%) exercise‐placebo group: 25/36 (69.4%) control group: 21/34 (58.3%) Comorbidities: experiencing lymphedema exercise‐therapy group: 16/34 (47.0%) exercise‐placebo group: 11/36 (30.6%) control group: 18/38 (47.3%) Past exercise history: assessed, but not reported On hormone therapy: exercise‐therapy group: 25/34 (73.5%) exercise‐placebo group: 25/36 (69.4%) control group: 29/38 (76.3%)
Interventions	34 participants assigned to the exercise therapy intervention, including: ‐1‐to‐1 sessions with an exercise specialist exercise education/guidance at each session Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: HR and RPE were assessed every 2 minutes during sessions. Exercise‐therapy sessions involved moderate‐intensity exercise (65% to 85% of age‐adjusted HR maximum and RPE of 12 to 13) Frequency: 3 times per week Duration of session: 50 minutes Duration of exercise program: 8 weeks Total number of exercise sessions: 24 Format: 1‐to‐1 Facility: university Professionally led: exercise specialist Exercise‐placebo group: 36 participants assigned to exercise‐placebo group, including: 24 1‐to‐1 50‐minute sessions during 8 weeks with light‐intensity body conditioning/stretching (e.g. flexibility and passive stretching) exercises during which HR was maintained below 40% HR reserve (typically was kept below 100 beats per minute) conversations on topics of everyday life Control group: 38 participants were assigned to the control group, including: no activity or education Adherence: attended at least 70% of sessions exercise‐therapy group: 77% exercise‐placebo group: 88.9% Contamination of control group: these groups did not increase their activity level
Outcomes	Primary outcome: QoL outcomes, including: FACT‐G FACT‐B Secondary outcomes included QoL and physiologic outcomes, including: fatigue, assessed using the Revised Piper Fatigue Scale satisfaction with life depression, assessed using the 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 behavior, assessed by asking participants how often they had participated in 1 or more physical activities for 20 to 30 minutes per session in the last 5 months and by completion of the stage of change for exercise ladder aerobic fitness, assessed using submaximal 8‐minute single‐stage walking test performed on a treadmill height weight body fat, using bioelectrical impedence analysis muscle function, assessed using Bioidex isokinetic machine Outcomes were measured at baseline and 8 and 24 weeks: exercise therapy group: n = 34 at baseline, n = 33 at week 8, n = 31 at week 24 exercise‐placebo group: n = 36 at baseline, n = 36 at week 8, n = 34 at week 24 control group: n = 38 at baseline, n = 33 at week 8, n = 31 at week 24 Adverse events: none reported
Notes	Country: UK Funding: Cancer Research UK
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 randomization service provided by an independent trials unit
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	High risk	"Outcome assessors were not blinded to participants' group allocation"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data were analyzed on an ITT basis. "The trial statistician was blinded to group codes. Little's test was used to examine whether missing data were missing completely at random"
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