Oh 2010.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 162; 79 to the exercise group and 83 to the control group Study start and stop dates: first recruitment phase was between July 2006 and August 2007 and the second recruitment phase was from August 2007 to May 2008 Length of intervention: 10 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: 36 (47.4%) of patients in the intervention group still undergoing cancer treatment and 34 (45.9%) in the control group; randomization stratified by whether still being treated or completed therapy Inclusion criteria:
Eligibility criterion related to interest or ability, or both, to exercise:
Exclusion criteria:
Gender, n (%):·
Age, mean (SD) years:
Age at cancer diagnosis: not reported Ethnicity, n (%):
Education level, n (%):
SES: not reported Employment status: not reported Comorbidities: not reported Past exercise history: limited by eligibility criteria On hormone therapy: not reported |
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Interventions | 79 participants assigned to exercise group, consisting of medical Qigong, with each session including:
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: mild Frequency: twice per week for 10 weeks and recommendation to practice at home daily Duration of sessions: 90 minutes for supervised sessions, 30 minutes for home sessions Duration of program: 10 weeks Total number of exercise sessions: maximum of 20 facility‐based and 70 home‐based sessions Facility: facility Professionally led: experienced medical Qigong instructor who was a Chinese medicine practitioner 83 participants assigned to control group, including:
Adherence: not reported Contamination of control group: not reported |
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Outcomes | Primary outcome of QoL included:
Secondary outcomes included:
Physiologic outcomes included:
Outcomes were measured at baseline and 10 weeks:
Subset: cognitive function outcomes were reported for a subset of patients enrolled after October 2007, including:
For this group, outcomes were measured at baseline and 10 weeks:
Subgroup analysis: none reported Adverse events: none reported |
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Notes | Country: Australia Funding: University of Sydney Cancer Research Fund |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization, by computer..." |
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 | Study personnel and outcome assessors were not masked or blinded to the study interventions |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis completed. There were 25 drop‐outs in the exercise group and 29 drop‐outs in the control group, and missing values were "dealt with by multiple imputation..." |
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 |