Burnham 2002.
Study characteristics | ||
Methods | Study design: RCT (participants matched on KPS and QoL) Number randomized: 21; 7 to a low‐intensity exercise group, 7 to a moderate‐intensity exercise group, and 7 to the control group Study start and stop dates: not reported Length of intervention: 10 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: breast or colon cancer; 5 breast cancer and 1 colon cancer in each of the 3 treatment groups Time since cancer diagnosis: not reported Time beyond active treatment, mean (SD) months:
Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both:
Exclusion criteria:
Gender: 15 female and 3 male Current age: 40 to 65 years of age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level: not reported SES: not reported Employment status: not reported Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported |
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Interventions | 7 participants assigned to the low‐intensity exercise group 7 participants assigned to the moderate‐intensity exercise group Type of exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: low intensity (25% to 35% of HR reserve) or moderate intensity (40% to 50% of HR reserve) Frequency: 3 times per week Duration of individual sessions: initially 14 minutes, divided equally among the 3 exercise modalities (4 minutes and 40 seconds on the treadmill, stair‐climber, and stationary bicycle in a rotational order). Increased by 2 minutes per week, up to 32 minutes at week 10 Duration of exercise program: 10 weeks Total number of exercise sessions: 30 Format: group Facility: facility Professionally led: unclear Adherence: 95% 7 participants assigned to the control, including:
Contamination of control group: 1 control participant increased exercise. That person and the match in the low‐ and moderate‐intensity exercise groups were removed from the study |
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Outcomes | Primary outcome: QoL outcomes, including:
Secondary outcomes: physiologic measures, including:
Outcomes were measured at baseline, 5 and 10 weeks:
Subgroup analysis by demographics Adverse events: none reported |
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Notes | Country: US Funding: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The generation of the random sequence was not described |
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, it was not possible to blind the participants; however, it is unclear whether the outcome was influenced by a lack of masking |
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 | High risk | "No subject in any group withdrew from the study...", but "One subject was excluded from the control group when a post‐study questionnaire revealed that she had engaged in significant exercise training during the course of the study... To maintain the matched group status, the two subjects matched with the excluded control subject were also removed from the analysis" |
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 |