Hacker 2011.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 22, but 2 did not have a transplant and 1 did not have baseline data. The author reported that 19 individuals were randomized, 9 to the exercise group and 10 to the control group Study start and stop dates: not reported Length of intervention: 6 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: hematologic malignancies Time since cancer diagnosis: not reported Time in active treatment: all receiving an HSCT Inclusion criteria:
Eligibility criteria related to interest or ability, or both, to exercise:
Exclusion criteria:
Gender, n: male, 14; female, 5 Current age, mean (SD, range) years: 46.26 (16.23, 20 to 67) years Age at cancer diagnosis: not reported Ethnicity/race, n: African Americans, 11; white, 7; Hispanic, 1 Education level, n: completed some college as their highest level of education, 10 SES, n: income level < USD40,000, 10 Employment status: not reported Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported |
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Interventions | 9 participants assigned to the exercise intervention, including:
Type exercise (aerobic/anaerobic): anaerobic Intensity of the experimental exercise intervention: Borg RPE scale of somewhat hard (Borg scale 13) Frequency: 3 times per week, once or twice at the clinic and once or twice at home Duration of individual sessions: varied Duration of exercise program: 6 weeks Total number of exercise sessions: 18 sessions Format: individual Facility: facility and home Professionally led: unsupervised and supervised by the principal investigator or a trained member of the research team Adherence: by week 2, all participants in the strength‐training group exercised at least once or twice per week, and most met the strength‐training prescription of exercising 3 times per week by week 3. All of the participants exercised at least once or twiceper week for at least 5 of the 6 weeks 10 participants assigned to control group, including:
Contamination of control group: not reported |
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Outcomes | No primary outcome was identified. QoL outcomes included:
Other outcomes included:
Outcomes were measured at baseline, 8 days after transplant (second baseline), and 6 weeks after discharge from the hospital:
Subgroup analysis: none Adverse events: 2 participants, 1 each from the exercise and control groups died during the course of the trial as a result of their underlying medical condition |
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Notes | Country: US Funding: National Institutes of Health/National Institute of Nursing Research |
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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 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. There was substantial attrition from the trial, especially in the intervention arm |
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 |