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

Bourke 2011.

Study characteristics
Methods Study design: RCT
Number randomized: 50; 25 to the exercise group and 25 to the control group
Study start and stop dates: not reported
Length of intervention: 12 weeks
Length of follow‐up: 6 months
Participants Type cancer: prostate cancer, nonlocalized, with metastatic disease
  • exercise group, n = 7

  • control group, n = 7


Time since cancer diagnosis: not reported
Time in active treatment: not reported
Inclusion criteria:
  • ≥ 6 months and currently on androgen suppression therapy

  • Histologically confirmed, nonlocalized prostate cancer


Eligibility criteria related to interest or ability, or both, to exercise:
  • sedentary

  • not undertaking regular physical activity, defined as exercise or physical activity at moderate intensity for 30 minutes or more 3 times per week


Exclusion criteria:
  • unstable angina

  • uncontrolled hypertension

  • recent myocardial infarction

  • pacemakers

  • painful or unstable bon metastasis


Gender: male
Current age, mean (SD) years:
  • exercise group: 71.3 (6.4) years

  • control group: 72.2 (7.7) 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, exercise behavior (Godin LSI), mean (SD):
  • exercise group: 13 (9)

  • control group: 15 (10)


On hormone therapy: all on androgen suppression therapy
Interventions 25 participants assigned to the exercise intervention, including:
  • anaerobic: supervised exercise sessions comprising 2 and 4 sets of resistance exercises (body weight resistance and free weights) targeting large skeletal muscle groups

  • aerobic: self‐directed exercise (e.g. brisk walking, cycling, or gym exercise) using a log book (23) to record activity

  • small group healthy eating seminars lasting 15 to 20 minutes fortnightly for 12 weeks


Type exercise (aerobic/anaerobic): aerobic and anaerobic
Intensity of the experimental exercise intervention:
  • aerobic: 55% to 85% age predicted maximum HR, or ratings of perceived exertion 11 to 15/fairly light to hard on the Borg RPE scale, or both

  • anaerobic: not reported


Frequency:
  • aerobic: once time per week during the initial 6 weeks and twice per week for the final 6 weeks

  • anaerobic: twice per week for the initial 6 weeks and once per week for the following 6 weeks


Duration of individual sessions: 30 minutes each
Duration of exercise program: 12 weeks
Total number of exercise sessions: 278 sessions
Format: individual; unclear if group "dedicated suite"
Facility: facility and home based
Professionally led by an exercise physiologist
Adherence:
  • aerobic: 329/378 sessions completed (87%)

  • anaerobic: 360/378 sessions completed (95%)


25 participants assigned to control group, including:
  • usual care


Contamination of control group: control group showed activity of 17.4 Godin LSI points at end of intervention (12 weeks)
Outcomes No primary outcome was identified. Outcomes included:
  • total exercise behavior, assessed using the Godin LSI

  • dietary macronutrient intake, assessed with 3‐day diet diaries

  • fatigue, assessed using the FACT‐F

  • global HRQoL, assessed using the FACT‐P and FACT‐G

  • physiologic/functional fitness, assessed by a trained blinded technician

  • anthopometric variables, assessed by BMI and weight

  • aerobic exercise tolerance, assessed by treadmill and Borg RPE scale

  • muscle strength assessed by MVT by isometric dynamometry of the quadriceps

  • functional fitness, assessed by maximum number of repetitions in 30 seconds in a standardized chair sit‐to‐stand test

  • circulating biomarker


Outcomes were measured at baseline, 12 weeks, and 6 months:
  • exercise group: n = 25 at baseline, n = 21 at 12 weeks, n = 15 at 6 months

  • control group: n = 25 at baseline, n = 22 at 12 weeks, n = 13 at 6 months


Subgroup analysis: none reported
Adverse events: drop‐outs owing to health problems were noted in 4 men in the exercise group (2 because of cardiac issues) and 5 men in the control group
Notes Country: US
Funding: none reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomization was carried out remotely using nQuery statistical software"
Allocation concealment (selection bias) Low risk " … without disclosure of the sequence to the researcher responsible for the running of the trial until after completion of the baseline assessments"
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 "Physiologic and functional fitness outcomes were assessed by a trained technician blinded to group allocation but blinding was not possible for those completing the HRQoL questionnaires"
Incomplete outcome data (attrition bias)
All outcomes High risk In the exercise group, 4 participants at 12 weeks and 6 at 6 months were lost to follow‐up. In the control group, 3 at 12 weeks and 9 at 6 months were lost to follow‐up. However, the investigators used the SPSS Expectation Maximization procedure to impute missing values so ITT analyses could be done
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