Donnelly 2011.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 33; 16 to the exercise group and 17 to the control group Study start and stop dates: recruitment form June 2008 to March 2009 Length of intervention: 12 weeks Length of follow‐up: 6 months |
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Participants | Type cancer, n (%): gynecologic cancers (ovarian, endometrial, uterine, cervical, or mixed)
Cancer stage, stage I to III, n (%):
Time since cancer diagnosis, mean (SD) months:
Time in active treatment: some women still receiving treatment Inclusion criteria:
Eligibility criterion related to interest or ability, or both, to exercise:
Exclusion criteria:
Gender: female Current age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level: not reported SES: not reported Employment status, n (%):
Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported |
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Interventions | 16 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: moderate Frequency: aim to meet physical activity guidelines (30 minutes of physical activity on at least 5 days per week) Duration of individual sessions: 30 minutes Duration of exercise program: 12 weeks Total number of exercise sessions: maximum of 60 sessions Format: individual Facility: home Professionally led with initial consultation with a professional physical therapist 17 participants assigned to control group, including:
Adherence: 44% of all participants, or 58% of all individuals who remained medically unfit to take part Contamination of control group: unclear |
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Outcomes | Primary outcome:
Secondary outcomes:
Outcomes were measured at baseline, 12 weeks (end of intervention), and 6‐month follow‐up (9 months after baseline):
Subgroup analysis: none reported Adverse events:
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Notes | Country: UK Funding: Department of Employment and Learning, Northern Ireland |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers table was used to generate the allocation sequence |
Allocation concealment (selection bias) | Low risk | Allocation was concealed in sequentially numbered opaque envelopes |
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 | The outcome assessor was blinded to the study allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The study used ITT analyses |
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 |