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

Ohira 2006.

Study characteristics
Methods Study design: RCT
Number randomized: 86; 43 to the exercise group and 43 to the delayed exercise control group
Study start and stop dates: October 2001 to June 2002
Length of intervention: 6 months
Length of follow‐up: to end of the intervention
Participants Type cancer: breast cancer
Cancer stage, n (%):
  • exercise group: DCIS, 7 (18%); Stage I, 16 (43%); Stage II, 13 (34%); Stage III, 2 (5%)

  • control Group: DCIS, 5 (12%); Stage I, 16 (39%); Stage II, 18 (44%); Stage III, 2 (5%)


Time since cancer diagnosis, mean (range) years:
  • exercise group: mean 1.73 (0.58 to 3.59) years

  • control group:  mean 2.02 (0.44 to 11.42) years


Time beyond active treatment, mean (range) years:
  • exercise group: mean 1.21 (0.28 to 2.84) years

  • control group: mean 1.09 (0.25 to 3.12) years


Inclusion criteria:
  • completed all treatment except hormonal therapy for breast cancer

  • body weight stable within 10% over the past year

  • nonsmokers for at least the past 2 years


Eligibility criterion related to interest or ability to exercise, or both:
  • sedentary to moderately physically active (no more than 3 sessions per week of no more than moderate‐intensity activity, no weight training history)


Exclusion criteria:
  • medical conditions prohibiting participation in a weight training program  

  • morbidly obese (BMI > 40 kg/m2)

  • hypertensive (systolic blood pressure > 160 mmHg, diastolic blood pressure > 99 mm Hg, or both)

  • currently on a weight loss plan or planning to start a weight loss plan during the period of the study

  • planning to move away from the area or be away from area for > 3 weeks during study

  • not pregnant or lactating, or planning to become pregnant during the study period


Gender: female
Current age, mean (SD) years:
  • exercise group: 53.3 (8.7) years

  • control group: 52.8 (7.6) years


Age at cancer diagnosis: not reported
Ethnicity/race, n (%) Caucasian:
  • exercise group: 39 (98%) Caucasian

  • control group: 41 (100%) Caucasian


Education level, n (%):
  • exercise group: some college or vocational training, 8 (20%); college degree, 22 (55%); graduate or professional degree, 10 (25%)

  • control group: some college or vocational training, 7 (17%); college degree, 22 (54%); graduate or professional degree, 12 (29%)


SES: not reported
Employment status: not reported
Comorbidities: not reported
Past exercise history: limited by eligibility criteria
On hormone therapy, n (%):
  • exercise group: tamoxifen, 30 (77%); anastozole 3 (8%); other 0 (0%)

  • control group: tamoxifen 27 (66%); anastozole 5 (12%); other, 1 (2%)


Other: postmenopausal, n (%):
  • exercise group: postmenopausal, 34 (85%)

  • control group: postmenopausal, 32 (78%)

Interventions 43 participants assigned to the exercise intervention, including:
  • 9 common weight‐training exercises using variable resistance machines and free weights (for muscles of the chest, back, shoulders, and arms, buttocks, hips, and thighs)

  • stretching exercises to perform before and after each weight‐training session


Type exercise (aerobic/anaerobic): aerobic and anaerobic
Intensity of experimental exercise intervention: not reported
Frequency: twice per week
Duration of sessions: not reported
Duration of program: 6 months
Total number of exercise sessions: maximum of 52
Format: started as supervised group (4 in a group); after 13 weeks, participants encouraged to work out with buddy(ies). Log sheets checked weekly by fitness trainer and if no data were recorded in 1 week, the fitness trainer called the participant
Facility: gym facility
Professionally led: certified fitness professional
43 participants assigned to control group, including:
  • waiting list


Adherence: baseline to 6 months, 1 participant attended < 80% of the sessions. From months 7 to 12, 14 exercise group participants attended < 70% of sessions
Contamination of control group: not reported
Outcomes Primary outcome: QoL and physiologic outcomes, including:
  • CARES‐SF, which includes 59 items and 5 subscales for physical, psychosocial, medical interaction, marital, sexual, and other miscellaneous subscales. Items are assessed using a 5‐point Likert scale (0 = 'not at all', 1 = 'a little', 2 = 'a fair amount', 3 = 'much', 4 = 'very much') that queries the applicability of the problem/statement to the patient within the last month. Items of the CARES‐SF are combined into a global summary score. Both the global summary score and individual subscale scores range from 0 to 100 and lower scores indicate fewer problems

  • weight

  • height

  • dual energy X‐ray absorptiometry (for body composition), including skin pinch meter/scale

  • standard blood panel

  • upper and lower body strength assessed by 1‐RM, using the same machines trained on for 9 exercises

  • depressive symptoms, measured with the CES‐D, a 20‐item questionnaire scored on a standard 4‐point scale (0 to 3) for each item, with a potential range of 0 to 60


Outcomes were measured at baseline and 6 months:
  • exercise group: n = 43 at baseline, n = 39 at 6 months

  • control group: n = 43 at baseline, n = 40 at 6 months


Subgroup analyses: post hoc subgroup analyses, including postmenopausal status, baseline levels of sport and leisure physical activity, baseline level of energy intake (kilocalories), and 6‐month changes in physical activity and energy intake
Adverse events:
  • cancer recurrence: n = 4 total, 2 recurrences each in the exercise and control groups

  • some limited musculoskeletal issues which were self resolving

Notes Country: US
Setting: Recreation center
Funding: Susan G. Komen Foundation and grants to the UMN GCRC from the NIH
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Random number table"
Allocation concealment (selection bias) Low risk "The randomization procedure used prevented investigators from influencing treatment allocation"
Blinding of participants and personnel (performance bias)
All outcomes High risk Owing to the nature of the intervention, masking or blinding of study participants was not possible; however, it is unclear whether the lack of masking could influence the outcomes
Blinding of outcome assessment (detection bias)
All outcomes Low risk "Measurement staff remained blinded until the end of the study, with the exception of the strength testing staff..."
Incomplete outcome data (attrition bias)
All outcomes High risk 4 participants lost to follow‐up in the exercise group, 2 due to recurrences and 2 due to withdrawals; 3 participants were lost to follow‐up in the control group, 2 due to recurrences and 1 due to withdrawal
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