Caldwell 2009.

Study characteristics
Methods	Study design: RCT Number randomized: 25; 13 to the exercise group and 12 to the control group Study start and stop dates: not reported Length of intervention: 12 weeks Length of follow‐up: 6 months
Participants	Type cancer: breast cancer Stage, n (%): exercise group: Stage I, 5 (38.5%); Stage II, 4 (30.8%); Stage III, 4 (30.8%) control group: Stage I, 2 (16.7%); Stage II, 7 (58.3%); Stage III, 3 (25.0%) Time since cancer diagnosis: not reported Time in active treatment: completed surgery, and scheduled to receive chemotherapy Inclusion criteria: had a clinical diagnosis of breast cancer (Stage I to III) 21 to 60 years old had undergone a definitive surgical procedure (lumpectomy or mastectomy) scheduled to receive any chemotherapy regimen/hormone blocker deemed as an appropriate treatment for breast cancer administered prior to (neoadjuvant) and after (adjuvant) surgical intervention approved to participate in the study by an oncologist who would oversee the participant's cancer treatment Eligibility criteria related to interest or ability, or both, to exercise: presence of concomitant major health problems in which an exercise regimen is contraindicated currently participating in a structured exercise program Exclusion criteria: male Gender: female Current age, mean (SD) years: exercise group: 47.15 (9.20) years control group: 46.33 (10.8) years Age at cancer diagnosis: not reported Ethnicity/race, n (%): exercise group: Asian, 1 (7.7%); African American, 2 (15.4%); Hispanic/Latino, 1 (7.7%); Caucasian, 9 (69.2%) control group: Asian, 0 (0.0%); African American, 1 (8.3%); Hispanic/Latino, 5 (41.7%); Caucasian, 6 (50.0%) Education level, n (%): exercise group: high school, 2 (15.4%); vocational, 1 (7.7%); some college, 2 (15.4%); college graduate, 8 (61.5%) control group: high school, 3 (25.0%); vocational, 1 (8.3%); some college, 2 (16.7%); college graduate, 6 (50.0%) SES: not reported Employment status: not reported Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported
Interventions	13 participants assigned to the exercise intervention, including: home‐based low‐intensity level strength training/functional endurance regimen including: biceps curl arm raises chair stands 1 foot stands side leg raises walking Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of the experimental exercise intervention: mild Frequency: 3 to 5 times per week Duration of individual sessions: as per participant ability and endurance Duration of exercise program: 12 weeks Total number of exercise sessions: 72 to 100 sessions Format: individual Facility: home Professionally led by a physical therapist Adherence: not reported 12 participants assigned to control group, including: usual care Contamination of control group: not reported
Outcomes	Primary outcome: fatigue, assessed using the SCFS Other outcomes included: Karnofsky's Performance Scale International Physical Activity Questionnaire timed Get Up and Go Test 6‐MWT Outcomes were measured at baseline and 6 months. 3 participants were not able to start the study owing to changes in treatment plan and were not included in any analysis: exercise group: n = 13 at baseline, n = 8 at 6 months control group: n = 12 at baseline, n = 9 at 6 months Subgroup analysis: not reported Adverse events: not reported
Notes	Country: US Funding: none reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"...computerized randomization program..."
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 conceal allocation to the intervention from the participants
Blinding of outcome assessment (detection bias) All outcomes	High risk	Allocation to the intervention was not concealed from the study personnel
Incomplete outcome data (attrition bias) All outcomes	High risk	Analyses were not conducted on an ITT basis and the treatment of missing data was not described. There was substantial attrition from the trial, especially in the intervention arm The number of participants who withdrew from the study was not reported beyond the 4‐week period
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