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. 2012 Aug 15;2012(8):CD007566. doi: 10.1002/14651858.CD007566.pub2

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
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:
  • female

  • breast cancer, stage 0 to lllb

  • post treatment


Eligibility criterion related to interest or ability to exercise, or both:
  • physician's clearance for fitness testing and exercise

  • engaging in moderate to vigorous physical activity more than once per week

  • physical limitations prohibiting exercise


Exclusion criteria:
  • clinical mental illness requiring psychotropic drugs, or by self report

  • presence of catheters or drains


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
Interventions 17 participants assigned to the exercise intervention, including Tai Chi Chuan, comprised of:
  • warm‐up exercises and basic Chi Kung for 10 minutes

  • Tai Chi Chuan for 40 minutes

  • 15‐move short‐form of Yang‐style Tai Chi Chuan

  • regulatory breathing, imagery and meditation for 10 minutes


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:
  • psychosocial support therapy


Adherence:
  • exercise group: 72% exercise rate with 100% compliance

  • control group: 67% attendance rate with 100% compliance


Contamination of control group: 10%
Outcomes Primary outcome: QoL outcomes, including:
  • FACIT‐F, 28‐question survey, scale from 0 to 4

  • self esteem assessed by RSE: scoring 1 ‐ strongly agree, 5 ‐ strongly disagree


Secondary outcomes: physical outcomes, including:
  • aerobic capacity, estimated using a 6‐minute walk test protocol

  • muscular strength, evaluated using a handgrip dynamometer to assess the maximal voluntary grip strength

  • flexibility, assessed using goniometer measurements


Outcomes were measured at baseline, 6 weeks, and 12 weeks (immediate postintervention):
  • exercise group: n = 17 at baseline, n = 11 at 6 weeks, n = 11 at 12 weeks

  • control group, n = 14 at baseline, n = 10 at 6 weeks, n = 10 at 12 weeks


Adverse events: no cancer recurrence reported; cognitive deficits reported as reason for treatment termination
Notes Country: US
Funding: Susan Stout Exercise Science Research Fund, Sally Schindel Cone Women's and Gender Studies Research Fund
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