Headley 2004.

Study characteristics
Methods	Study design: RCT Number randomized: 38; the number of participants originally assigned to the exercise or control group not reported Study start and stop dates: not reported Length of intervention: 12 weeks Length of follow‐up: to end of the intervention
Participants	Type cancer: breast cancer, Stage IV Time since cancer diagnosis: not reported Time in active treatment: not reported Inclusion criteria: scheduled to initiate outpatient chemotherapy would be receiving HDC for the purpose of bone marrow or stem cell transplantation or would be receiving hormonal therapy as a single treatment English‐literate ≥ 18 years of age Eligibility criteria related to interest or ability, or both, to exercise: having performance status of ≤ 2 on the Zubrod scale being able to sit in a straight back chair for at least 30 minutes having access to a television and video cassette player Exclusion criteria: received radiation therapy during the prior 2 months serum hemoglobin level ≤ 8.0 g/dL resting pain level of > 2 on a 0 to 10 pain scale symptomatic bone metastases Gender: female Current age, mean (SD) years: exercise group: 52.25 (11.43) years control group: 50.00 (7.10) years Age at cancer diagnosis: not reported Ethnicity/race, n: exercise group: Caucasian, 15; African American, 1 control group: Caucasian, 12; African American, 4 Education level, years of education, mean (SD): exercise group: 12.60 (2.5) years control group: 14.4 (3.12) years SES: not reported Employment status, n: exercise group: not employed, 10; employed full‐time, 6; employed part‐time, 0 control group: not employed, 7; employed full‐time, 8; employed part‐time, 1 Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported
Interventions	The number of study participants originally assigned to the exercise intervention not reported. Data available for 16 participants assigned to the exercise intervention, including: 30‐minute seated exercise program in which participants sit in a straight backed chair while performing stretching and repeated flexion and extension of the arms, head, upper torso, and legs with the assistance of a video The program includes: a 5‐minute warm‐up, 20 minutes of moderate‐intensity repetitive motion exercises, and a 5‐minute cool‐down Type exercise (aerobic/anaerobic): aerobic Intensity of the experimental exercise intervention: moderate Frequency: 3 times per week Duration of individual sessions: 30 minutes Duration of exercise program: 12 weeks Total number of exercise sessions: 36 sessions Format: individual Facility: home Not professionally led Adherence: not reported The number of study participants originally assigned to the control intervention not reported. Data available for 16 participants assigned to the control group, including: permission to continue any usual physical activity Contamination of control group: not reported
Outcomes	No primary outcome was identified. QoL outcomes included: fatigue, assessed using the FACIT‐F Version IV global QoL, using the FACIT‐F Outcomes were measured at baseline and at the beginning of each course of chemotherapy for 12 weeks for a total of 4 measurements. The numbers by treatment group not reported. The total number of participants at each time point included: baseline, n = 32; cycle 2, n = 28; cycle 3, n = 30; cycle 4, n = 24 Subgroup analysis: none Adverse events: not reported
Notes	Country: US Funding: ONS Foundation and the University of Texas Health Sciences Center in the Houston School of Nursing
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer used to generate the random sequence
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	Study personnel and outcome assessors were not masked or blinded to the study interventions
Incomplete outcome data (attrition bias) All outcomes	High risk	There was no discussion on how missing data were addressed. In addition, there were no ITT analyses as data on women who did not complete the study were excluded from the analyses
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