Bourke 2011.

Methods	Design: prospective, randomised, controlled pilot trial Country: UK Accrual dates: NR Trial Reg: NR
Participants	Number randomised: 18 180 participants were identified through nurse‐led follow‐up clinics; 29 responded as interested, 11 were screened out due to ineligibility, 9 were randomised to intervention, 9 were randomised to control, 1 was lost to follow‐up Inclusion: histologically confirmed colon cancer, which had been resected 6 to 24 months previously Exclusion: existing participation in regular physical activity; Karnofsky rating < 80; unstable angina; uncontrolled hypertension; recent myocardial infarction or a pacemaker Age, years (SD): 52 to 80 (69) Intervention arm: 67.9 (5.7) Control arm: 70.3 (8.7) Gender: Intervention: 5 male, 4 female Control: 7 male, 2 female Ethnicity: NR Type of cancer: colon Therapy previously received for cancer: surgery: n = 17, chemotherapy: n = 6, palliative care: n = 1 Cancer stage: NR Baseline physical activity: chair sit‐to‐stand reps Intervention arm: 10 median (range 8 to 16) Control arm: 10 median (range 7 to 16) Education: NR
Interventions	Comparison: supervised and home‐based exercise with dietary advice vs cancer follow‐up service Intervention: 12‐week lifestyle intervention made up of supervised and home‐based exercise sessions and dietary advice. Exercise sessions took place within a dedicated exercise suite at Sheffield Hallam University and were supervised by an experienced exercise physiologist. During the first 6 weeks, participants attended 2 group‐based supervised exercise sessions per week. During the final 6 weeks, participants attended the university facility once a week and were asked to perform 2 home‐based exercise sessions a week. Participants were also provided with a nutrition advice info pack on a fortnightly basis throughout the intervention and engaged in healthy eating seminars in a group format Control: holistic nurse‐led colorectal cancer follow‐up service
Outcomes	Dietary changes: 3‐day diaries kept by the participant to self‐report food intake Changes in weight/anthropometry: weight, height, BMI, and hip‐to‐waist ratio measured by exercise physiologist Quality of life: FACT‐C used to assess disease‐specific QoL Duration of follow‐up: 12 weeks
Notes	Funding: eNIHR Cardiovascular Biomedical Research Unit
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were randomised by an independent researcher via code numbers using nQuery statistical software
Allocation concealment (selection bias)	Low risk	Randomisation was undertaken by a senior academic who was not directly involved in recruitment or assessment of patients. The randomisation sequence was not disclosed to the researcher responsible for day‐to‐day running of the trial until patients had completed baseline assessments
Blinding of participants and personnel (performance bias) Objective outcomes	Low risk	No blinding; outcome is not likely to be influenced by lack of blinding
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	No blinding; outcome is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Assessor of outcomes was blinded to group allocation
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	No blinding of outcome assessment; outcome measurement was patient self‐reported and therefore is likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) Objective	Low risk	Only 1 person dropped out due to stroke (6% attrition). ITT was used
Incomplete outcome data (attrition bias) Subjective	Low risk	Only 1 person dropped out due to stroke (6% attrition). ITT was used
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement
Other bias	Unclear risk	Insufficient information