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. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2

Courneya 2003b.

Study characteristics
Methods Study design: RCT
Number randomized: 102; 69 to the exercise group and 33 to a waiting list control group
Study start and stop dates: October 1998 to April 2001
Length of intervention: 16 weeks
Length of follow‐up: to end of the intervention
Participants Type cancer: colorectal cancer
Time since cancer diagnosis: not reported
Time beyond active treatment: surgery within the last 3 months
Inclusion criteria:
  • recovery from surgery as indicated by attending physician

  • ability to understand English


Eligibility criterion related to interest or ability to exercise, or both:
  • passed the revised Physical Activity Readiness Questionnaire

  • no contraindications to exercise as determined by a submaximal cardiorespiratory fitness test


Gender:
  • exercise group: 54.8% male

  • control group: 64.5% male


Current age, mean (SD) years:
  • exercise group: mean 59.92 (10.73) years

  • control group: 61.1 (9.93) years


Age at cancer diagnosis: not reported
Ethnicity/race: not reported
Education level:
  • exercise group: 35% completed university

  • control group: 46.4% completed university


SES:
  • exercise group: 65.5% with income > USD40,000

  • control group: 53.6% with income >USD40,000


Employment status:
  • exercise group: 29.5% employed full time

  • control group: 30.0% employed full time


Comorbidities: not reported
Past exercise history: mean (SD) number of minutes of exercise per week:
  • exercise group: mild exercise, 121.45 (214.60) minutes; moderate exercise, 77.98 (137.01) minutes; strenuous exercise, 13.47 (69.36) minutes; total, 212.90 (248.04) minutes; % > 60 moderate/strenuous exercise, 40.3%, % > 150 moderate/strenuous, 27.4%

  • control group: mild exercise, 164.03 (295.10); moderate exercise, 68.87 (97.57); strenuous exercise, 27.74 (57.43); total, 260.65 (323.77); % > 60 moderate/strenuous exercise, 41.9%, % > 150 moderate/strenuous, 32.3%


On hormone therapy: not reported
Interventions 69 participants assigned to the experimental exercise intervention, including:
  • home‐based personalized exercise program that could be any activity designed to "improve functional wellbeing through cardiovascular and flexibility exercises", if none, walking prescribed


Type exercise (aerobic/anaerobic): unclear
Intensity of experimental exercise intervention: to 65% to 75% of HR
Frequency: 3 to 5 times per week
Duration of session: 20 to 30 minutes
Duration of exercise program: 16 weeks
Total number of exercise sessions: 48 to 80
Format: individual
Facility: home based
Not professionally led, but designed by professional
Adherence: overall adherence, 75.8%
Calculated as effect size (difference in variable between groups divided by SD of control group):
  • mild exercise = 0.20

  • moderate exercise = 0.16

  • strenuous exercise = 0.07

  • moderate/strenuous = 0.15

  • total exercise = 0.07


% > 60 moderate/strenuous, 75.8%
% > 150 moderate/strenuous, 41.9%
33 participants assigned to control:
  • waiting list control


Contamination of control group: overall, 51.6%
Calculated as effect size (difference in variable between groups divided by SD of control group)
% > 60 moderate/strenuous, 51.6%
% > 150 moderate/strenuous, 32.3%
Outcomes Primary outcome: QoL, measured at week 16 using:
  • FACT‐C scale, includes subscales for physical, functional, emotional and social/family well‐being, and colorectal subscale

  • FACT‐G, excludes colorectal subscale

  • TOI score (sum of physical and FWB subscale and colorectal subscale)


Secondary outcomes, all measured at 16 weeks included:
  • satisfaction with life, measured using the Satisfaction with Life scale (5 items rated on 7‐point scale)

  • depression, measured using the CES‐D scale

  • anxiety, measured using the STAI

  • cardiovascular fitness, measured using Modified Balke Treadmill Test

  • body composition, measured using Harpenden calipers

  • flexibility, measured using the sit and reach test


Outcomes were measured at baseline and end of the intervention:
  • exercise group: n = 69 at baseline, n = 62 after intervention

  • control group: n = 33 at baseline, n = 31 after intervention


Adverse events: none reported
Notes Study country: Canada
Funding source: NCIC and Alberta Heritage Foundation for Medical Research; Canadian Institutes of Health Research, CCS, Sociobehavioral Cancer Research Network
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Used a "random‐numbers table"
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, masking or blinding of study participants was not possible; however, it is unclear whether the lack of masking could influence the outcomes
Blinding of outcome assessment (detection bias)
All outcomes Low risk Fitness test conducted by certified fitness consultant blinded to the experimental group
Incomplete outcome data (attrition bias)
All outcomes Low risk Reasons for exclusions presented
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