Courneya 2007a.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 242; 78 to an aerobic exercise group, 82 to a resistance exercise group, and 82 to the control group Study start and stop dates: February 2003 to July 2005 Length of intervention: length of the chemotherapy session (median 17 weeks; 95% CI 9 to 24 weeks) Length of follow‐up: 6 months |
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Participants | Type cancer: breast cancer Stage, n (%)
Time since cancer diagnosis: not reported Time in active treatment: not reported Inclusion criteria:
Eligibility criteria related to interest or ability, or both, to exercise:
Exclusion criteria:
Gender: female Current age, mean (range) years:
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level, completed university, n (%):
SES, income > USD60,000 per year, n (%):
Employment status, full time employed, n (%):
Comorbidities, hypertension, n (%):
Past exercise history, n (%)
On hormone therapy: not reported Obese, n (%):
BMI, n (%):
Current smoker, n (%):
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Interventions | 78 participants assigned to the aerobic exercise intervention, including:
82 participants assigned to the resistance exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic or anaerobic Intensity of the experimental exercise intervention:
Frequency: 3 times per week Duration of individual sessions:
Duration of exercise program: length of chemotherapy (~ 17 weeks) Total number of exercise sessions: ~ 51 sessions Format: individual Facility: facility Professionally led by exercise trainers Adherence:
82 participants assigned to control group, including:
Contamination of control group: not reported |
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Outcomes | No primary outcome was identified. QoL outcomes included:
Other outcomes included:
Outcomes were measured at baseline, at mid‐point, at end of the intervention, and at 6‐month follow‐up:
Subgroup analysis: subgroups included patient preference, marital status, age, disease stage, chemotherapy protocol Adverse events: 2 participants experienced an adverse event related to exercise after baseline maximal treadmill testing: 1 became lightheaded, hypotensive, and moderately nauseous and 1 experienced dizziness, weakness, and mild diarrhea |
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Notes | Country: Canada Funding: Canadian Breast Cancer Research Alliance, Canada Research Chairs Program, NCIC with funds from the CCS and the NCIC/CCS Sociobehavioral Cancer Research Network, Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research, Alberta Heritage Foundation for Medical Research |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated |
Allocation concealment (selection bias) | Low risk | The allocation sequence was generated in Edmonton and concealed from the project directors at each site who assigned participants to groups |
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 | Low risk | Used all available data in ITT analyses, using the missing at random assumption for mixed models |
Selective reporting (reporting bias) | Low risk | There is no evidence of 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 |