Wiskemann 2011.
Study characteristics | ||
Methods | Study design: Multicenter RCT Number randomized: 112; 57 to the exercise group and 55 to the control group Study start and stop dates: recruitment took place starting in May 2007 and the last participant completed the trial in February 2009 Length of intervention: at least 7 to 12 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer, n:
Time since cancer diagnosis: not reported Time in active treatment, median (range) days:
Inclusion criteria:
Eligibility criteria related to interest or ability, or both, to exercise: not reported Exclusion criteria: not reported Gender, n (%):
Current age, mean (range) years:
Age at cancer diagnosis: not reported Ethnicity/race: not reported Education level: not reported SES: not reported Employment status: not reported Comorbidities: none reported Past exercise history, sedentary (< once per week physically active) at baseline, n (%):
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Interventions | 57 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): aerobic and anaerobic Intensity of the experimental exercise intervention: Borg scale target scores of 12 to 14 for endurance and 14 to 16 for resistance exercises Frequency: 3 endurance (up to 5 during hospitalization) and 2 resistance training sessions per week Duration of individual sessions:
Duration of exercise program: length of treatment Total number of exercise sessions: 21 to 36 endurance sessions and 14 to 24 resistance training sessions Format: individual Facility: home and facility based Professionally supervised during the inpatient period and unsupervised during the outpatient period Adherence: from baseline (medical check‐up) until admission = 87.5%; during hospitalization, 83.0%; outpatient period from discharge until study end (6 to 8 weeks later), 91.3% 55 participants assigned to control group, including:
Contamination of control group: not reported |
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Outcomes | Primary outcome was fatigue, assessed using:
Secondary outcomes included:
Outcomes were measured at baseline, at admission to hospital (second baseline), at discharge from hospital, and at 6 to 8 weeks after discharge:
Subgroup analysis: none reported Adverse events: 24 participants (11 in the exercise and 13 in the control group) died |
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Notes | Country: Germany Funding: German Jose Carreras Leukemia Foundation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation sequence was generated using the minimization procedure |
Allocation concealment (selection bias) | Unclear risk | Whether the treatment assigned 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 conceal allocation to the intervention from the participants |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Allocation to the intervention was not concealed from the study personnel |
Incomplete outcome data (attrition bias) All outcomes | High risk | Analyses were not conducted on an ITT basis and the treatment of missing data was not described. Although the authors used last observation carried forward for the participants who did not complete the last study visit, they excluded randomized individuals who were considered ineligible after randomization (missing donor, revised diagnosis, contraindications in check‐up, dropped out) |
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 |