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

Crowley 2003.

Study characteristics
Methods Study design: RCT
Number randomized: 22; 13 to the exercise group and 9 to the control group
Study start and stop dates: not reported
Length of intervention: 13 weeks
Length of follow‐up: to end of the intervention
Participants Type cancer: breast cancer
Cancer stage, n (%): Stage I, 13 (59.1%); Stage II, 9 (40.9%)
Time since cancer diagnosis: not reported
Time in active treatment: completed surgery, initiating adjuvant chemotherapy of four 3‐week cycles of adriamycin and cytoxan
Inclusion criteria:
  • ages 35 to 60 years

  • complete primary surgery

  • receiving adjuvant chemotherapy, specifically adriamycin and cytotoxan


Eligibility criteria related to interest or ability, or both, to exercise:
  • medical condition that did not allow participation in a structured exercise program

  • commitment to not initiating participation in a formal exercise program during the study period

  • continuation of an ongoing exercise regimen was acceptable


Exclusion criteria:
  • previous history of cancer treated with cytotoxic drugs or radiation therapy

  • breast reconstruction at the time of primary surgery

  • treatment regimen that required radiation therapy either before or concurrent with chemotherapy

  • pre‐existing cardiac or pulmonary disease

  • current pregnancy or active lactation

  • inability to give informed consent


Gender: female
Current age, range: 36 to 58 years
Age at cancer diagnosis: not reported
Ethnicity/race, n (%): Caucasian, 21 (95.5%); African American, 1 (4.5%)
Education level, n (%): high school, 1 (4.5%); vocational school, 1 (4.5%); some years of college, 6 (27.3%); college graduate, 14 (63.6%)
SES: not reported
Employment status, n (%): unemployed, 3 (13.6%); full‐time, 14 (63.6%); part‐time, 5 (22.7%)
Comorbidities: not reported
Past exercise history: not reported
On hormone therapy: not reported
Menopausal status, n (%): premenopausal, 12 (54.5%); postmenopausal, 10 (45.5%)
Interventions 13 participants assigned to the exercise intervention, including:
  • 13‐week home‐based structured endurance and strength training exercise program

    • endurance component consisted of a home‐based walking program

    • strength training component consisted of the performance of progressive resistance training using exercise tubing


Type exercise (aerobic/anaerobic): aerobic and anaerobic
Intensity of the experimental exercise intervention:
  • endurance component: 60% of the target HR

  • strength training: not reported


Frequency: 3 to 5 times per week
Duration of individual sessions: not reported
Duration of exercise program: 13 weeks
Total number of exercise sessions: 39 to 65 sessions over 13 weeks
Format: individual
Facility: home
Professionally led in that education provided by an exercise physiologist twice during the program, once at the beginning and once during week 8
Adherence: average days walked per week was 3.66 days or 113 minutes per week
9 participants assigned to control group, including:
  • usual care


Contamination of control group: average days walked per week was 1.79 days or 53 minutes per week
Outcomes Primary outcomes: non‐HRQoL and HRQoL outcomes including:
  • non‐HRQoL outcomes:

    • physical performance/endurance, assessed using a symptom limited graded exercise test with the Cornell Treadmill Protocol to measure functional capacity (VO2max/kg)

    • physical self‐efficacy, assessed using the Self‐Efficacy to Perform Self‐Management Behaviors and the Self‐Efficacy to Achieve Outcomes scales

    • strength, assessed using a 1‐repetition maximal chest press and leg press

  • HRQoL outcomes were:

    • fatigue, assessed using the Revised PFS to measure overall fatigue and 4 subscales, behavioral/severity, sensory, affective/meaning, and cognitive/mood; and subject report of fatigue assessed using the AFI

    • attention performance, assessed using the AFI as a measure of cognitive function

    • functional wellness, assessed using the MOS SF‐36 Health Survey measuring subscales of physical functioning, role‐physical, bodily pain, general health, vitality, social functioning, role‐emotional, and mental health

    • health transitions, assessed using a single‐item question included on the SF‐36

    • belief of current state of health, assessed using the Functional Wellness Questionnaire


Outcomes were measured at baseline, 7 weeks, and 13 weeks:
  • exercise group: n = 13 at baseline (for all outcomes), n = 13 at 7 weeks (all outcomes, except physical performance/endurance), n = 13 at 13 weeks (all outcomes)

  • control group: n = 9 at baseline (for all outcomes), n = 9 at 7 weeks (all outcomes, except physical performance/endurance), n = 9 at 13 weeks (all outcomes)


Subgroup analysis: none reported
Adverse events: not reported
Notes Country: US
Funding: Sigma Theta, Rho Chapter, Oncology Nursing Society Foundation, Pharmacia & Upjohn
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers table used, with consecutive numbers on the table used with those numbers ending in an even integer assigned to the exercise group, and numbers ending in an odd integer assigned to the control group
Allocation concealment (selection bias) Low risk Each random number placed in an envelope that was sealed and consecutively numbered on the outside
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 Allocation to the intervention was not concealed from the study personnel
Incomplete outcome data (attrition bias)
All outcomes High risk Analyses were not conducted on an ITT basis and the treatment of missing data was not described.  It is unclear how much attrition occurred in the trial
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