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

Segal 2003.

Study characteristics
Methods Study design: RCT
Number randomized: 155; 82 to the exercise group and 73 to the control group
Study start and stop dates: September 1999 to August 2001
Length of intervention: 12 weeks
Length of follow‐up: to end of the intervention
Participants Type cancer: prostate cancer
Stage, n (%):
  • exercise group: Stage I, 0 (0%); Stage II, 40 (48.8%); Stage III, 11 (13.4%); Stage IV, 17 (20.7%); unassignable, 14 (17.1%)

  • control group: Stage I, 0 (0%); Stage II, 35 (47.9%); Stage III, 13 (18.1%); Stage IV, 10 (13.9%); unassignable, 15 (20.8%)


Time since cancer diagnosis, mean (SD) days:
  • exercise group: 980.1 (1115.4) days

  • control group: 762.9 (1292.6) days


Time in active treatment: "scheduled to receive androgen deprivation therapy"
Inclusion criteria:
  • histologically documented prostate cancer

  • scheduled to receive androgen deprivation therapy for at least 3 months after recruitment

  • treating oncologist provided consent


Eligibility criteria related to interest or ability, or both, to exercise:
  • none


Exclusion criteria:
  • severe cardiac disease (NYHA class III or greater)

  • uncontrolled hypertension (blood pressure > 160/95 mmHg)

  • uncontrolled pain

  • unstable bone lesions

  • residence > 1 hour from the study center


Gender: male
Current age, mean (SD) years
  • exercise group: 68.2 (7.9) years

  • control group: 67.7 (7.5) 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; prior activity level, n (%):
  • exercise group: < twice per week, 31 (37.8%); ≥ 3 times per week, 51 (62.2%); prior resistance training at < twice per week, 64 (78.0%); ≥ 3 times per week, 16 (22.0%)

  • control group: < twice per week, 26 (35.6%); ≥ 3 times per week, 47 (64.4%); prior resistance training at < twice per week, 56 (76.7%); ≥ 3 times per week, 17 (23.3%)


On hormone therapy: not reported
Interventions 82 participants assigned to the exercise intervention, including:
  • personalized resistance exercise program  consisting of  a standardized series of warm‐up and cool‐down exercises to be performed under supervision with 2 sets of 8 to 12 repetitions of the following 9 exercises were  performed: leg extension, calf raises, leg curl, chest press, latissimus pull‐down, overhead press, triceps extension, biceps curls, and modified curl‐ups


Type exercise (aerobic/anaerobic): anaerobic
Intensity of the experimental exercise intervention: at 60% to 70% of 1‐repetition maximum, increasing resistance by 5 lb when > 12 repetitions
Frequency: 3 times per week
Duration of individual sessions: as needed to complete program
Duration of exercise program: 12 weeks
Total number of exercise sessions: 36 sessions
Format: individual
Facility: fitness center
Professionally led by a certified fitness consultant
Adherence: attendance averaged 79% (28 of 36 sessions)
73 participants assigned to control group, including:
  • waiting list


Contamination of control group: not reported
Outcomes Primary outcomes included:
  • fatigue, assessed using the FACT‐F

  • global HRQoL, assessed using the FACT‐P


Other outcomes included:
  • muscular fitness, assessed using a standard load test

  • body composition, including BMI, weight, waist circumference, subcutaneous skin‐folds


Outcomes were measured at baseline and end of the intervention:
  • exercise group: n = 82 at baseline, n = 74 at postintervention

  • control group: n = 73 at baseline, n = 61 at postintervention


Subgroup analysis:
  • curative versus palliative treatment goal

  • receiving androgen deprivation therapy for < 1 year versus longer


Adverse events: none reported
Notes Country: Canada
Funding: NCIC. CCS; Heart and Stroke Foundation of Canada; Canadian Institutes of Health Research CCS/NCIC Sociobehavioral Cancer Research Network.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Table of random numbers
Allocation concealment (selection bias) Low risk "The treatment allocation was concealed from the study coordinator until completion of baseline testing and stratification"
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 Unclear risk Study personnel and outcome assessors for the HRQoL outcomes were not masked or blinded to the study interventions. However, blinding was used for physical outcomes "A research assistant with no knowledge of group assignment collected muscular fitness and anthropometric data and scored questionnaire responses"
Incomplete outcome data (attrition bias)
All outcomes High risk 8 men in the exercise group and 12 in the control group withdrew
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