Mustian 2009.

Study characteristics
Methods	Study design: RCT Number randomized: 40; 20 to the exercise group and 20 to the control group Study start and stop dates: August 2004 to December 2006 Length of intervention: 4 weeks Length of follow‐up: 3 months
Participants	Type cancer: breast cancer and prostate cancer Time since cancer diagnosis: not reported Time in active treatment: not reported Inclusion criteria: primary diagnosis of breast or prostate cancer completion of enrolment and baseline assessments before the end of the first calendar week of radiation treatments at least 30 scheduled radiation treatments (6 weeks) Eligibility criteria related to interest or ability, or both, to exercise: sedentary lifestyle no contraindications prohibiting participation in a low‐ to moderate‐intensity walking or resistance exercise program or physical fitness testing, as assessed by patients' radiation oncologist (or physician designee) Exclusion criteria: distant metastases recurrent disease Gender, n (%): exercise group: male, 6 (32%), female, 13 (68%) control group: male, 5 (26%), female, 14 (74%) Current age, mean (SD, range) years: exercise group: 56.6 (13.7, 36 to 82) years control group: 63.3 (9.4, 48 to 78) years Age at cancer diagnosis: not reported Ethnicity/race, n (%): exercise group: white, 16 (84%); Asian, 2 (11%); black, 1 (5%) control group: white, 18 (95%); Asian, 0 (0%); black, 1 (5%) Education level; partial college education or greater, n (%): exercise group: 16 (84%) control group: 12 (63%) SES: not reported Employment status, currently employed, n (%): exercise group: 17 (90%) control group: 12 (63%) Comorbidities: not reported Past exercise history: all were "sedentary" On hormone therapy, n (%): exercise group: 1 (5%) control group: 2 (10%) Weight, mean (SD, range) lbs: exercise group: 173.7 (46.8, 109 to 256) lb control group: 188.3 (43.9, 130 to 264) lb BMI, mean (SD, range) exercise group: 28.7 (5.4, 21 to 39) control group: 31.3 (6.8, 20 to 42)
Interventions	20 participants assigned to the exercise intervention, including: aerobic and anaerobic program provided as a single, 45‐minute, instructional session and a prepackaged individual "exercise kit" with written instructions and materials necessary for the patient to complete the home‐based walking and resistance band exercise intervention the individually tailored aerobic component included a walking program the individually tailored resistance band exercise prescription included individually determined number of sets (1 set = 8 to 15 repetitions) for each of the 11 exercises (i.e. bicep curl, tricep extension, overhead press, rows, chest press, internal and external rotation, lateral and front raises, horizontal adduction, and abduction) with instructions to increase resistance to a maximum of 4 sets of 15 repetitions for each exercise daily Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of the experimental exercise intervention: aerobic: moderately intense aerobic exercise (60% to 70% of HR reserve, 3 to 5 exercise rating of perceived exertion on the AC SM revised rating scale) anaerobic: low to moderately intense progressive resistance exercise (3 to 5 exercise rating of perceived exertion on the AC SM revised rating scale) Frequency: 7 times per week Duration of individual sessions: not reported Duration of exercise program: 4 weeks Total number of exercise sessions: 28 sessions Format: individual Facility: facility and home Professionally led by a certified exercise scientist Adherence: 15/19 reported increased daily steps walked; 12/19 reported doing resistance training at the end of the intervention; 8/19 maintained resistance training through 3‐month follow‐up. Change in number of steps from baseline to 4 weeks, 3997 (5959) and at 3 months, 5792 (7094.6); change in minutes daily resistance at 4 weeks, 9.43 (11.44), at 6 weeks and at 3 months 6.81 (9.94); change in days/week resistance at 4 weeks, 3.05 (2.99) and at 3 months, 1.33 (2.52) 20 participants assigned to control group, including: usual care Contamination of control group: 1/19 reported resistance training at 3‐month follow‐up. Change in number of steps from baseline to 4 weeks, ‐572.3 (2139.1) and at 3 months, ‐64.4 (2756.4); change in minutes daily resistance at 4 weeks, ‐1.57 (4.73), at 6 weeks and at 3 months, ‐1.03 (6.06); change in days/week resistance at  4 weeks, ‐0.21 (0.63) and 3 months, ‐0.12 (0.86)
Outcomes	No primary outcome was identified. QoL outcomes included: fatigue, assessed using the BFI global QoL and fatigue, assessed using the FACIT‐F Non‐HRQoL outcomes included: 6‐MWT handgrip dynamometry bioelectrical impedance Outcomes were measured at baseline, 4 weeks, and 3 months: exercise group: n = 19 at baseline, n = 19 at 4 weeks, n = 19 at 3 months control group: n = 19 at baseline, n = 19 at 4 weeks, n = 19 at 3 months Subgroup analysis: none Adverse events: none reported
Notes	Country: US Funding: National Cancer Institute
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"using a randomization scheme with blocks of four"
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	The study appears to have been blinded at baseline, but it is not clear if it was at follow‐up, "A clinical research coordinator obtained patient consent and collected all the self‐report assessments (e.g. BFI) while a second coordinator with a Master's in Exercise Science performed the objective tests (e.g. 6‐minute walk, handgrip dynamometer) and explained the home‐based exercise program to participants." The study statistician and data managers remained blinded at all times
Incomplete outcome data (attrition bias) All outcomes	Low risk	"Data were analyzed on an "intent‐to‐treat" basis, with patients being analyzed in the group to which they were assigned." 1 participant from each group withdrew before any measures were made
Selective reporting (reporting bias)	Low risk	There is no evidence of 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