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

Segal 2001.

Study characteristics
Methods Study design: RCT
Number randomized: 123; 40 to the home‐based exercise group, 42 to the supervised exercise group, and 41 to the control group
Study start and stop dates: not reported
Length of intervention: 26 weeks
Length of follow‐up: to end of the intervention
Participants Type cancer: breast cancer, Stages I and II
Time since cancer diagnosis: not reported
Time in active treatment: within 2 weeks
Inclusion criteria:
  • Stages I and II breast cancer

  • within 2 weeks of the initiation of prescribed adjuvant therapy (radiation therapy, hormonal therapy, or chemotherapy)


Eligibility criteria related to interest or ability, or both, to exercise:
  • treating oncologist believed that exercise was not indicated


Exclusion criteria:
  • receiving only alternative or dose‐intensive chemotherapy regimens

  • severe cardiac disease

  • uncontrolled hypertension (160/95 mmHg blood pressure)


Gender: female
Current age, mean (SD) years:
  • home‐based exercise group: 51.0 (8.7) years

  • supervised exercise group: 51.4 (8.7) years

  • control group: 50.3 (8.7) years


Age at cancer diagnosis: not reported
Ethnicity/race: not reported
Education level: not reported
SES: not reported
Employment status: not reported
Comorbidities: not reported
Past exercise history; "physically active", %:
  • home‐based exercise group: 60%

  • supervised exercise group: 50%

  • control group: 47.6%

Interventions 40 participants assigned to the home‐based exercise intervention and 40 to the supervised exercise intervention. Both groups included:
  • instructions for monitoring exercise intensity and completing an exercise diary, along with a standardized series of warm‐up and cool‐down exercises and a progressive walking program


The home‐based (self‐directed) exercise group also included:
  • home exercise prescription

  • contact by telephone every 2 weeks during the 26‐week training period to check on progress and  identify barriers to exercise


The supervised exercise group also included:
  • a supervised exercise program with a 7‐ to 10‐minute warm‐up, walking at prescribed pace, and standard cool‐down.


Type exercise (aerobic/anaerobic): aerobic
Intensity of the experimental exercise intervention: 50% to 60% of the predicted maximal oxygen uptake
Frequency:
  • home‐based: 5 times per week

  • supervised: 3 times per week in the facility and asked to exercise at home 2 days per week


Duration of individual sessions: not reported
Duration of exercise program: 26 weeks
Total number of exercise sessions: 130 sessions
Format: individual
Facility: both home and facility
Professionally led by an exercise specialist
Adherence: not reported
41 participants assigned to control group, including:
  • general advice from the oncologist about the benefits of exercise and a suggestion to participants to exercise if they felt well enough

Outcomes Primary outcome included:
  • change in physical functioning, assessed by measuring change in the physical functioning subscale of  the MOS SF‐36


Other outcomes included:
  • global HRQoL, assessed using the other subscales of MOS SF‐36, FACT‐G, and FACT‐B

  • aerobic capacity

  • body weight


Outcomes were measured at baseline, 13 weeks, and 26 weeks:
  • home‐based exercise group: n = 40 at baseline, n = 40 at 13 weeks, n = 40 at 26 weeks (imputed values carried forward, so even though withdrawals, analyses included all participants)

  • supervised exercise group: n = 40 at baseline, n = 40 at 13 weeks, n = 40 at 26 weeks (imputed values carried forward, so even though withdrawals, analyses included all participants)

  • control group: n = 41 at baseline, n = 41 at 13 weeks, n = 41 at 26 weeks (imputed values carried forward, so even though withdrawals, analyses included all participants)


Subgroup analysis: treated with chemotherapy versus other treatment
Adverse events: none reported
Notes Country: Canada
Funding: National Cancer Institute of Canada, CCS
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers table
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 Low risk Values carried forward for withdrawals, and withdrawals balanced across groups: home‐based exercise, 7; supervised, 8; control, 7
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