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

Culos‐Reed 2010.

Study characteristics
Methods Study design: RCT
Number randomized: 100; 53 to the exercise group and 47 to the control group
Study start and stop dates: recruitment occurred between 2004 and 2006
Length of intervention: 16 weeks
Length of follow‐up: 12 months
Participants Type cancer: prostate cancer
Time since cancer diagnosis: not reported
Time in active treatment: not reported
Inclusion criteria:
  • diagnosis of prostate cancer (any stage)

  • may or may not have had previous treatment

  • expected to receive androgen deprivation therapy for at least 6 months


Eligibility criteria related to interest or ability, or both, to exercise:
  • physician's clearance to participate in a hybrid exercise program consisting of aerobic, strength, and flexibility components


Exclusion criteria:
  • any comorbid condition that would restrict the participant's ability to enter the program (e.g. heart disease, emphysema, and arthritis)

  • high risk of osteoporotic fracture because of long‐term steroid use or T‐score < −2.5 on screening bone mineral densitometry DXA scan


Gender: male
Current age, mean (SD, range) years:
  • exercise group: 67.2 (8.8, 46 to 82) years

  • control group: 68.0 (8.4, 49 to 86) years


Age at cancer diagnosis: not reported
Ethnicity/race: not reported
Education level, n (%):
  • exercise group: some high school, 12 (23.1%); completed high school, 10 (19.2%); some university/college, 8 (15.4%); completed university/college, 17 (32.7%); some/completed graduate school, 5 (9.6%)

  • control group: some high school, 7 (14.9%); completed high school, 6 (12.8%); some university/college, 12 (25.5%); completed university/college, 11 (23.4%); some/completed graduate school, 11 (23.4%)


SES, annual income, n (%):
  • exercise group: < USD20,000, 4 (8.3%); USD20,000 to USD39,999, 13 (27.1%); USD40,000 to USD59,999, 7 (14.6%); USD60,000 to USD79,000, 9 (18.8%); > USD80,000, 15 (31.3%)

  • control group: < USD20,000, 3 (6.8%); USD20,000 to USD39,999, 14 (31.8%); USD40,000 to USD59,999, 14 (31.8%); USD60,000 USD79,000, 6 (13.6%); > USD80,000, 7 (15.9%)


Employment status, n (%):
  • exercise group: full‐time, 16 (30.2%); retired, 30 (56.6%); disability/sick leave, 3 (5.7%); other, 4 (7.6%)

  • control group: full‐time, 5 (10.6%); retired, 31 (66.0%); disability/sick leave, 1 (2.1%); other, 10 (21.2%)


Comorbidities: not reported
Past exercise history: not reported
On hormone therapy: not reported
Interventions 53 participants assigned to the individualized physical activity exercise intervention, including:
  • home‐based component primarily consisting of walking, stretching, and light resistance (i.e. theraband)

  • group‐based component in a fitness center consisting of an activity component (walking, stretching, light resistance) and education/discussion


Type exercise (aerobic/anaerobic): aerobic
Intensity of the experimental exercise intervention: moderate
Frequency:
  • home‐based component: 3 to 5 times per week

  • group‐based component: once per week during the 16‐week intervention and once per month until completion of the follow‐up assessments


Duration of individual sessions:
  • home‐based component: 60 minutes

  • group‐based component: 90 minutes


Duration of exercise program: 16 weeks
Total number of exercise sessions:
  • home‐based component: 156 to 260 sessions

  • group‐based component: 24 sessions


Format: individual and group
Facility: home and facility (fitness center)
Group‐based component professionally led by certified fitness professional
Adherence: not reported
47 participants assigned to control group, including:
  • waiting list control


Contamination of control group: not reported
Outcomes Primary outcome:
  • physical activity behavior, assessed using the Godin LSI of the Godin Leisure Time Exercise questionnaire


Other outcomes included:
  • HRQoL, assessed using the European Organization for the Research and Treatment of Cancer, Quality of Life Study Group (QLQ‐C30)

  • organ‐specific function and bother, assessed using the EPIC

  • fatigue, assessed using the Fatigue Severity Scale

  • depression, assessed using the CES‐D scale


Outcomes were measured at baseline, 16 weeks, 6 months, and 12 months:
  • exercise group: n = 53 at baseline, n = 53 at 16 weeks, n = 53 at 6 months, n = 53 at 12 months

  • control group: n = 47 at baseline, n = 47 at 16 weeks, n = 47 at 6 months, n = 47 at 12 months


Subgroup analysis: not reported
Adverse events: not reported
Notes Country: Canada
Funding: none reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The generation of the random sequence was not described
Allocation concealment (selection bias) Unclear risk Whether the treatment assigned 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 Allocation to the intervention was not concealed from the study personnel
Incomplete outcome data (attrition bias)
All outcomes Low risk Analyses were conducted on an ITT basis
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