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:
Eligibility criterion related to interest or ability to exercise, or both:
Gender:
Current age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level:
SES:
Employment status:
Comorbidities: not reported Past exercise history: mean (SD) number of minutes of exercise per week:
On hormone therapy: not reported |
|
Interventions | 69 participants assigned to the experimental exercise intervention, including:
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):
% > 60 moderate/strenuous, 75.8% % > 150 moderate/strenuous, 41.9% 33 participants assigned to 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:
Secondary outcomes, all measured at 16 weeks included:
Outcomes were measured at baseline and end of the 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 |