Mustian 2004.
Study characteristics | ||
Methods | Study design: RCT Number randomized: 31; 17 to a Tai Chi Chuan exercise group and to 14 to the control group Study start and stop dates: not reported Length of intervention: 12 weeks Length of follow‐up: to end of the intervention |
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Participants | Type cancer: breast cancer, Stage 0 to IIIb Time since cancer diagnosis: not reported Time beyond active treatment: between 1 week and 30 months Inclusion criteria:
Eligibility criterion related to interest or ability to exercise, or both:
Exclusion criteria:
Gender: female Current age, mean (SD, range): 52 (9, 33 to 78) years Age at cancer diagnosis: not reported Ethnicity/race: 90% Caucasian Education level: 90% some college SES: > USD40,000 household income, 62% Employment status: employed outside the home, 65% Comorbidities: not reported Past exercise history: not reported On hormone therapy: 56% had received hormonal therapy but specific hormones not reported |
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Interventions | 17 participants assigned to the exercise intervention, including Tai Chi Chuan, comprised of:
Type exercise (aerobic/anaerobic): aerobic Intensity of experimental exercise intervention: moderate Frequency: 3 times per week Duration of sessions: 60 minutes Duration of program: 12 weeks Total number of exercise sessions: 36 Format: group Facility: facility Professionally led: ACSM‐certified health and fitness instructor certified in Tai Chi Control group: 14 participants assigned to the control group, including:
Adherence:
Contamination of control group: 10% |
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Outcomes | Primary outcome: QoL outcomes, including:
Secondary outcomes: physical outcomes, including:
Outcomes were measured at baseline, 6 weeks, and 12 weeks (immediate postintervention):
Adverse events: no cancer recurrence reported; cognitive deficits reported as reason for treatment termination |
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Notes | Country: US Funding: Susan Stout Exercise Science Research Fund, Sally Schindel Cone Women's and Gender Studies Research Fund |
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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 blind the participants; however, it is unclear whether the outcome was influenced by a lack of masking |
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 | High risk | 6 participants in the exercise group and 4 in the control group withdrew and were not included in the 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 |