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

Segar 1998.

Study characteristics
Methods Study design: quasi‐randomized partial cross‐over controlled trial. We include only the first treatment period
Number randomized: 30; 10 to an exercise group, 10 to an exercise and behavioral modification group, and 10 to a control group. The exercise and exercise and behavioral modification groups were combined for all analyses
Study start and stop dates: not reported
Length of intervention: 10 weeks
Length of follow‐up: 12 weeks
Participants Type cancer: breast cancer
Time since cancer diagnosis: not reported
Time beyond active treatment, mean (SD, range) months: 41.8 (24.9, 1 to 99) months
Time since surgery, mean (SD, range) months:
  • exercise groups: 43.7 (26.2, 1 to 99) months

  • control group: 38.1 (23.2, 5 to 73) months


Inclusion criteria:
  • any type of breast cancer surgery

  • 30 to 65 years old


Eligibility criterion related to interest or ability to exercise, or both:
  • not currently participating in exercise

  • no contraindications to exercise

  • written release from the physician


Exclusion criteria:
  • cardiovascular or pulmonary disease

  • known physical disabilities


Gender: female
Current age, mean (SD, range) years:
  • exercise groups: 47.5 (7.1, 35 to 62) years

  • control group: 51.8 (8.1, 40 to 64) years


Age at cancer diagnosis: not reported
Ethnicity/race:
  • exercise groups: white, 70%; black, 12%; Asian, 12%; and Native American, 6%

  • control group: white, 88%; black, 12%


Education level:
  • exercise groups: graduate training, 38%; college graduate, 31%; some college, 25%; and high school graduate, 6%

  • control group: graduate training, 12%; college graduate, 38%; some college, 25%; and high school graduate, 25%


SES: not reported
Employment status:
  • exercise groups: employed outside the home, 56%; homemaker, 25%; unemployed, 0; retired, 6%; other, 13%

  • control group: employed outside the home, 25%; homemaker, 12%; unemployed, 25%; retired, 13%; other, 25%


Comorbidities: not reported
Past exercise history: not reported
On hormone therapy: not reported
Interventions 10 participants assigned to the exercise group, including
  • request to exercise a minimum of 30 minutes on 4 days per week, with type of exercise (stationary bike, stair climbers, and hydraulic resistance exercise equipment) as chosen by participant


Type exercise (aerobic/anaerobic): aerobic
Intensity of experimental exercise intervention: ≥ 60% of age‐predicted maximum HR (mild to moderate)
Frequency: 4 days per week
Duration of session: 30 to 40 minutes per session
Duration of program: 10 weeks
Total number of exercise sessions: 40
Format: unclear
Facility: exercise facility was at the university or that of the participants' preference
Professionally led: not professionally led
10 participants assigned to the exercise and behavioral modification group, including:
  • exercise as described for the exercise group

  • behavioral modification by self awarded rewards (activity, food, treats, or movies) to serve as reinforcements


Adherence: overall compliance, assessed from self‐reported exercise logs averaged 1363 (SD = 577) minutes over the 10 weeks, where 100% compliance is equivalent to 1,200 minutes. Average compliance for participants reaching at least 89% compliance was 1532 (SD = 103) minutes (mean compliance of 130%) with a range form 89 to 250%
10 participants initially assigned to the control group, including:
  • instructions to maintain sedentary lifestyle


Contamination of control group: unclear
Outcomes Outcomes: QoL outcomes, including:
  • change in depressive symptoms, measured using the 21‐item BDI  questionnaire, with scale score ranging between 0 and 63. A higher score indicates greater depressive symptoms

  • change in anxiety symptoms, measured using the STAI, 20 items, 1 = not at all, 4 = very much so

  • change in self esteem, measured using the RSE Inventory, which is a unidimensional 64‐item questionnaire with 10 scales that reflect self‐evaluation of self‐esteem


Outcomes were measured at baseline and at 10 weeks:
  • exercise groups: n = 16 at baseline, n = 16 at 10 weeks

  • control group: n = 8 at baseline, n = 8 at 10 weeks


Adverse events: none reported
Notes Country: US
Funding: Michigan Initiative for Women's Health Grant
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk "Subjects were rotated sequentially into two treatment conditions and one control group"
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 4 participants were excluded from the exercise group and 2 participants were excluded from the control group. Exclusion from the analyses occurred because of attrition or noncompliance with the study protocol
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