Bourke 2011.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 18; 9 to the exercise group and 9 to the control group Study start and stop dates: not reported Length of intervention: 12 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: colon cancer, Dukes stages A to C Time since cancer diagnosis: not reported Time beyond active treatment: 6 to 24 month
Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both:
Exclusion criteria:
Gender, n:
Current 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 BMI, mean (SD) kg/m2:
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Interventions | 9 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of experimental exercise intervention: 55% to 85% of age predicted maximum HR Frequency: twice per week of supervised sessions and once per week at home for first 6 weeks, then once per week supervised session and twice per week at home for last 6 weeks Duration of individual sessions: 30 minutes and time necessary to complete resistance training Duration of exercise program: 12 weeks Total number of exercise sessions: 36 Format: group and individual Facility: Northern General Hospital, Sheffield, UK Professionally led: professionally led by experienced exercise physiologist at facility 9 participants assigned to control group, including:
Adherence: 90% attendance (completed 146 of 162 sessions) and 94% compliance Contamination of control group: reported no significant difference in exercise behavior as assessed by Godin LSI (15; 95% CI 2 to 28) |
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Outcomes | No primary outcome identified. QoL outcomes included:
Physical outcomes included:
Outcomes were measured at baseline and at 12 weeks:
Subgroup analysis: none reported Adverse events: not reported |
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Notes | Country: UK Funding: Sheffield Hallam University |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence was generated via code numbers using nQuery statistical software |
Allocation concealment (selection bias) | Low risk | Allocation was undertaken by a senior academic who was not directly involved in the recruitment or assessment of patients. The randomization sequence was not disclosed to the researcher responsible for the day‐to‐day running of the trial until patients had completed the baseline assessments |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Owing to the nature of the intervention, it was not possible to mask or blind the participants; however, it is unclear whether the lack of masking or blinding could influence the outcomes |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The researcher responsible for the day‐to‐day running of the trial was informed of the randomization after collection of the baseline data. Other study personnel were not masked or blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis was used to compare participants in the groups they were randomly assigned and data were carried over from previous visits in cases of withdrawal of participants. One participant in the intervention group withdrew owing to a cerebrovascular accident |
Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcome |
Other bias | Low risk | The trial appears to be free of other problems that could put it at a high risk of bias |