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

Mock 2005.

Study characteristics
Methods Study design: RCT
Number randomized: 119; 60 to the exercise group and 59 to the control group
Study start and stop dates: recruitment between 1998 and 2001
Length of intervention: for the duration of treatment, 6 weeks if radiation therapy or 3 to 6 months if chemotherapy
Length of follow‐up: to end of the intervention
Participants Type cancer: breast cancer
Stage, %
  • exercise group: Stage 0, 20%; Stage I, 45%; Stage II, 35%; Stage IIIa, 0%

  • control group: Stage 0, 27.2%; Stage I, 40.7%; Stage II, 25.4%; Stage IIIa, 6.7%


Time since cancer diagnosis: not reported
Time in active treatment: initiating adjuvant therapy
Inclusion criteria:
  • 18 to 70 years old


Eligibility criteria related to interest or ability, or both, to exercise:
  • concurrent major health problems that could affect participation in an exercise program, including obesity (BMI > 35 kg/m2), cardiovascular disease, acute or chronic respiratory disease, cognitive dysfunction

  • engaged in active exercise (> 45 minutes per week)


Exclusion criteria:
  • no additional exclusions


Gender: female
Current age, mean (SD) years:
  • exercise group: 51.3 (8.9) years

  • control group: 51.6 (9.7) years


Age at cancer diagnosis: not reported
Ethnicity/race, % Caucasian:
  • exercise group: 85.0%

  • control group: 79.3%


Education level, years of education, mean (SD) years:
  • exercise group: 15.1 (2.8) years

  • control group: 14.9 (2.7) years


SES: not reported
Employment status: 73% employed
Comorbidities: not reported
Past exercise history: not reported
On hormone therapy: not reported
Adjuvant treatment: radiation therapy, 58%; chemotherapy, 42%
Interventions 60 participants assigned to the exercise intervention, including:
  • walking briskly for 15 minutes and increasing to 30 minutes as training progressed


Type exercise (aerobic/anaerobic): aerobic
Intensity of the experimental exercise intervention: target HR range of ~ 50% to 70% of maximum HR
Frequency: 5 or 6 times per week
Duration of individual sessions: 45 minutes
Duration of exercise program: 6 weeks for radiation or 3 to 6 months for chemotherapy
Total number of exercise sessions: varied
Format: individual
Facility: home
Not professionally led
Adherence: defined as engaging in ≥ 60 minutes of aerobic activity for at least 67% of the duration of the trial: 39/54 (72%) adhered
59 participants assigned to control group, including:
  • usual care, with contact from the research team every 2 weeks for attention control


Contamination of control group: defined as exceeding 45 minutes of aerobic activity weekly for 67% of the duration of the trial: 33/54 (61%) were not contaminated; 39% were contaminated
Outcomes Primary outcome:
  • fatigue, assessed using the PFS


Other outcomes included
  • physical function, assessed using

    • 12‐MWT

    • SF‐36 Physical Function Scale

    • Physical Activity Questionnaire


Outcomes were measured at baseline and end of the intervention:
  • exercise group: n = 54 at baseline, n = 54 at end of the intervention

  • control group: n = 54 at baseline n = 54 at end of the intervention


Subgroup analysis: high walkers (>60 minutes per week in ≥ 3 sessions) versus low walkers (< 60 minutes per week or not at all)
Adverse events: not reported
Notes Country: US
Funding: Fatigue Initiative in Research and Education multi‐institutional award from the Oncology Nursing Society Foundation
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated
 
Allocation concealment (selection bias) Low risk Number sealed opaque envelopes
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 No ITT analyses were performed and 6 participants withdrew from the exercise group and 5 form the control group
Selective reporting (reporting bias) Low risk There is no evidence of 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