Knols 2011.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 131; 64 to the exercise group and 67 to the control group Study start and stop dates: enrolment from January 2005 to November 2008 Length of intervention: 12 weeks Length of follow‐up: 3 months from end of the intervention |
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Participants | Type cancer, n (%):
Time since cancer diagnosis: not reported Time between HSCT and study, mean (SD) days:
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, n (%):
SES: not reported Employment status: not reported Comorbidities: not reported Past exercise history, n (%):
On hormone therapy: not reported Other, BMI, mean (SD, range):
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Interventions | 64 participants assigned to the exercise intervention, including a supervised physical exercise program with:
Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of experimental exercise intervention: 20 minutes at a predefined individual HR (from 50% to 60%, increasing up to 70% to 80% of the estimated maximum HR) Frequency: twice per week Duration of individual sessions: 10 minutes warm‐up, 20 minutes maintenance plus time for resistance training Duration of exercise program: 12 weeks Total number of exercise sessions: 24 Format: unclear if individual or group Facility: facility base in a physical therapy practice or fitness center Professionally led by physiotherapist or a physical trainer 67 participants assigned to the control group, including:
Adherence: average participation in the physical exercise program was 85% (range = 21% to 100%), representing about 20.5 of 24 training sessions. 22 patients attended all (100%) of the sessions; 37.5% attended > 80% of the sessions; 17.2% attended ≥ 66% of the sessions; and 10.9% attended < 66% of the sessions Contamination of control group: 7.5% of the control group patients reported a minimum of 20 physical exercise sessions |
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Outcomes | Primary outcome included QoL and physical outcomes, including:
Secondary QoL outcomes included:
Secondary physical function outcomes included:
Outcomes were measured at baseline, 12 weeks, and 3 months:
Subgroup analysis: several subgroup analyses were prespecified and conducted Adverse events: none reported |
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Notes | Country: Switzerland Funding: Zurcher Kresliga (Zurich) and the Eidenossiche Sportkommission (Magglingen) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence generated using a minimization procedure |
Allocation concealment (selection bias) | Low risk | Results of the randomisation were "...stored in opaque envelopes. The allocation sequence and contents of the envelopes were concealed by study personnel" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Owing to the nature of the intervention, participants and study personnel could not be masked or blinded to the allocation to the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Independent assessors of physical outcomes were blinded to group assignments and carried out the assessments |
Incomplete outcome data (attrition bias) All outcomes | Low risk | In the exercise group, 7 participants lost by end of intervention and additional 6 from end of intervention to end of the follow‐up. In control group, 10 participants lost by end of 12 weeks and additional 3 at end of follow‐up. Investigators included all study participants in the 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 |