DeNysschen 2011.

Methods	Study design: single‐centre RCT Number randomised: 100; 36 to exercise begun during treatment (EE), 30 to exercise begun after treatment (CE), 34 to control Study start and stop dates: 1999 to 2006 Length of intervention: 4 to 6 months Length of follow‐up: at 1 year from baseline Country: USA
Participants	Age, years (mean SD): Intervention (EE): 48.7 (8.4) Intervention (CE): 49.5 (9.5) Control: 51.6 (10.9) Stage, n (%): Intervention (EE): stage I, 13 (39.4); stage II, 14 (42.4); stage III, 6 (48.2) Intervention (CE): stage I, 11 (39.3); stage II, 15 (53.6); stage III, 2 (7.1) Control: stage I, 14 (42.4); stage II, 13 (39.4); stage III, 6 (18.2) Inclusion criteria: • Women aged 18 years or older • Confirmed diagnosis of breast cancer • Beginning second cycle of chemotherapy • Ability to read, write, and understand English • Mentally able to understand and able to provide written informed consent • Karnofsky Performance Scale (KPS) score > 60 Exclusion criteria: • Receiving concurrent radiotherapy for another disease • Had bone marrow transplantation • Uncontrolled hypertension or diabetes mellitus • Pain intensity rating ≥ 3 on a 0 to 10 numerical scale • Lytic bone lesion or other orthopaedic limitations • History of major depression or sleep disorders • Chemotherapy in the past year • Diagnosis of AIDS‐related malignancies or leukaemia • Absolute contradictions to exercise testing as established by American College of Sports Medicine (1995)
Interventions	66 participants assigned to exercise intervention (36 to EE, 30 to CE): Individualised programme adjusted to participant’s fitness level and adjusted weekly to maintain the exercise prescription. Programme consisted of cardiovascular/aerobic exercise of participants' choice (e.g. walking, jogging, cycling) performed 3 to 5 times per week for 30 minutes at 2‐ to 14‐point intensity level (Borg scale, moderate exertion) over 4 to 6 months 30 participants assigned to control: Usual care; telephoned weekly by research nurse to enquire about their health Adherence: EE group reported adherence rate of 74% by end of intervention and 78% by end of follow‐up; CE group reported 86% adherence at end of intervention
Outcomes	No primary outcome stated: Physical activity questionnaire recorded self‐reported exercise activities, frequency, intensity, and duration Physical performance measured on Karnofsky Performance Status (KPS) scale Symptom checklist: list of 25 symptoms commonly experienced by individuals receiving chemotherapy. Format is a Likert‐type rating scale with descriptive anchors from 0 = none to 10 = terrible/awful Body composition via DEXA (fat mass, percent fat, lean body mass) Cardiorespiratory fitness assessed by maximal exercise testing Outcomes measured: • EE group: n = 36 at baseline, n = 36 at 4 to 6 months (end of intervention) • CE group: n = 30 at baseline, n = 30 at 4 to 6 months (end of intervention) • Control group: n = 34 at baseline, n = 34 at 4 to 6 months (end of intervention) Adverse events: none reported
Notes	Trial registration link: none available Trial authors contacted: no Intention‐to‐treat analysis: no missing data evident in this study Funding: National Cancer Institute; Clinical & Translational Science Institute, Clinical Research Center
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Generation of random sequence was not described.
Allocation concealment (selection bias)	Unclear risk	Whether 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 participants.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Measurements of study variables were taken by research nurses who were blinded to the participants' group assignment".
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing data were reported.
Selective reporting (reporting bias)	High risk	Data on cardiorespiratory fitness and on physical activity were not reported.
Other bias	High risk	Control group and intervention groups were reported as having similar activity levels as intervention groups post intervention, possible contamination. Low adherence rate of 74% by end of intervention and 78% at end of follow‐up in the intervention group