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. 2012 Aug 15;2012(8):CD008465. doi: 10.1002/14651858.CD008465.pub2

Danhauer 2009.

Study characteristics
Methods Study design: RCT
Number randomized: 44; 22 to the exercise group and 22 to the control group
Study start and stop dates: recruitment from August 2005 to October 2006
Length of intervention: 10 weeks
Length of follow‐up: to end of the intervention
Participants Type cancer: breast cancer, DCIS or Stages I to IV
Cancer stage, n (%):
  • exercise group: DCIS, 3 (13.6%); Stage I, 5 (22.7%); Stage II, 10 (45.5%); Stage III, 3 (13.6%); Stage IV, 1 (4.6%)

  • control group: DCIS, 5 (22.7%); Stage I, 9 (40.9%); Stage II, 3 (13.6%); Stage III, 2 (9.1%); Stage IV, 3 (13.6%)


Time since cancer diagnosis, mean (SD) months:
  • exercise group: 24.4 (39.5) months

  • control group: 22.8 (35.6) months


Time in active treatment: 2 to 24 months post primary treatment (surgery); 34% still in active treatment
Inclusion criteria:
  • ≥ 18 years old

  • 2 to 24 months post primary treatment (surgery) following initial diagnosis

  • recurrence of breast cancer within the past 24 months (regardless of treatment status)

  • able to understand English


Eligibility criterion related to interest or ability, or both, to exercise:
  • physically able to attend restorative yoga classes


Exclusion criteria:
  •  medical contraindications as reported by physician


Gender: female
Current age, mean (SD) years:
  • exercise group: 54.3 (9.6) years

  • control group: 57.2 (10.2) years


Age at cancer diagnosis: not reported
Ethnicity/race, n (%):
  • exercise group: non‐Hispanic White, 19 (86.4%); African American, 2 (9.1%); Asian/Pacific Islander, 1 (4.6%)

  • control group: non‐Hispanic White, 20 (90.9%); African American, 1 (4.6%); Asian/Pacific Islander, 1 (4.6%)


Education level, n (%):
  • exercise group: high school diploma/GED, 0 (0.0%); some college or vocational school, 6 (27.3%); college graduate, 5 (22.7%); graduate study or degree, 1 (50.0%)

  • control group: high school diploma/GED, 3 (13.6%; some college or vocational school, 8 (36.4%); college graduate, 3 (13.6%); graduate study or degree, 8 (36.4%)


SES, n (%):
  • exercise group: < USD35,000, 6 (30.0%); USD35,000 to USD49,999, 3 (15.0%); USD50,000 to USD99,999, 8 (40.0%); USD100,000+, 3 (15.0%)

  • control group: < USD35,000, 5 (27.8%); USD35,000 to USD49,999, 1 (5.6%); USD50,000 to USD99,999, 5 (27.8%); USD100,000+, 6 (33.3%)


Employment status: not reported
Comorbidities: not reported
Past exercise history, n (%):
  • exercise group: never had done yoga, 20 (90.9%); no yoga experience in the past year, 20 (90.9%)

  • control group: never had done yoga, 15 (68.2%); no yoga experience in the past year, 18 (81.8%)


On hormone therapy: not reported
Ongoing treatment, n (%):
  • exercise group: receiving chemotherapy, 8 (36.4%); receiving radiation therapy, 6 (27.3%)

  • control group: receiving chemotherapy, 3 (13.6%); receiving radiation therapy, 3 (13.6%)

Interventions 22 participants assigned to the exercise intervention, including:
  • restorative yoga which combined physical postures (asanas), breathing (pranayama), and deep relaxation (savasana). Yoga poses were modified based on participant needs. Poses included: mountain pose; arm and shoulder stretch; supported forward fold; seated sun salutation; and reclining twist with a bolster


Type exercise (aerobic/anaerobic): aerobic/anaerobic
Intensity of experimental exercise intervention: mild
Frequency: once per week
Duration of individual sessions: 75 minutes
Duration of exercise program: 10 weeks
Total number of exercise sessions: 10 sessions
Format: group
Facility: Wake Forest University Health Sciences and local studio
Professionally led by yoga instructor with cancer‐specific yoga training who was registered by the National Yoga Alliance
22 participants assigned to control group, including:
  • waiting list for yoga


Adherence: 11 women attended 7 or more sessions; 6 women attended 3 to 6 sessions; and 5 women attended ≤ 2 sessions
Contamination of control group: not reported
Outcomes No primary outcomes were identified. Outcomes included:
  • physical health status (PCS and MCS), measured using the MOS's SF‐12

  • HRQoL, measured using the FACT‐B, which consists of the subPWB subscale, SWB subscale, EWB subscale, FWB subscale, and breast cancer specific concerns

  • fatigue, measured using the FACT‐F scale

  • spirituality, measured using the FACT‐Sp, which has 2 domains, sense of meaning/peace and role of faith. Only the sense of meaning/peace subscale was included in this study

  • depression, measured using the CES‐D

  • sleep dysfunction, measured using the PSQI

  • positive and negative affect, measured using the PANAS


Outcomes were measured at baseline and at 10 weeks (end of the intervention):
  • exercise group: n = 22 at baseline, n = 13 at 10 weeks

  • control group: n = 22 at baseline, n = 14 at 10 weeks


Adverse events: cancer recurrence was reported for 4 women in the exercise group and 6 women in the control group. No adverse events were reported
Notes Country: US
Funding: Wake Forest University Comprehensive Cancer Center
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 Study personnel and outcome assessors were not masked or blinded to the study interventions
Incomplete outcome data (attrition bias)
All outcomes High risk Data were analyzed on an ITT basis. Participants who failed to return the study questionnaire were excluded from the analyses ‐ 9 participants in the exercise group and 7 participants in the control group did not return the study questionnaire. 1 participant in the control group withdrew from the study
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