Feasibility of Measuring Exercise's Effects on Molecular Mechanisms of Disease Progression in Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Other: Exercise
- Registration Number
- NCT02481648
- Lead Sponsor
- Vancouver Prostate Centre
- Brief Summary
The investigators aim to evaluate the feasibility of a larger clinical trial assessing an exercise program during the "teachable moment" in patients with prostate cancer and measuring its effect on tumor apoptosis signaling, lipogenesis and steroidogenesis. Participants will be randomized between a 4-12 week exercise program or to standard of care only. Participants will be assessed at screening, baseline (day 0), throughout the trial intervention (days 1-84), post-intervention visit (prior to radical prostatectomy) and final study visit 6-months post-radical prostatectomy. At each assessment, physical, biological samples and psychosocial assessments will take place.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 20
Not provided
• Men with a medical, musculoskeletal condition or use of mobility aid that prevents participation in the exercise intervention.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARM1: Exercise Intervention Exercise The exercise program is a 4-12 weeks progressive combined resistance and aerobic exercise for participants from time of diagnosis to RP. Participants will undergo twice weekly group-training (four-six participants/group) combined aerobic-resistance sessions (1hr per session), supervised by trained exercise therapists. In addition, participants will undergo home-based aerobic exercise independently three times a week with the goal to meet the current physical activity guidelines for cancer survivors (150min/week of moderate intensity aerobic activity and two resistance training sessions per week). Participants will also be supplied with the Canadian Physical Activity and Sedentary Behavior Guidelines Handbook and accompanying Log Sheets.
- Primary Outcome Measures
Name Time Method Feasibility: Proportion of screen eligible patients who enroll From start of recruitment to end of recruitment Feasibility: Treatment-specific retention rates From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks Feasibility: Proportion of planned assessments that are completed respectively From date of randomization to end of study for each participant, an average of 7 months Feasibility: Number of patients screened per month From start of recruitment to end of recruitment Feasibility: Number of patients enrolled per month From start of recruitment to end of recruitment Feasibility: Rates of adherence to protocol for the exercise intervention arm and control arm From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks
- Secondary Outcome Measures
Name Time Method Physical Fitness: Anthropometrics (i.e. BMI & waist circumference) Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery Comparison of baseline versus end of study anthropometrics
Physical Fitness: Muscular strength test upper and lower extremity using the 1RM Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery Comparison of baseline versus end of study muscular strength
Physical Fitness: Blood pressure and pulse Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery Comparison of baseline versus end of study blood pressure and pulse
Psychosocial: International Index of Erectile Function scale (IIEF) Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery Comparison of questionnaire scores at baseline versus end of study
Physical Fitness: Godin Leisure-Time Exercise questionnaire (GLTEQ) and activity logs Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery Comparison of activity at baseline, during the study and at the end of the study
Physical Fitness: Functional fitness using the 30-second chair stand and 30-second arm curl Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery Comparison of baseline versus end of study functional fitness
Biological: Collection of urine, blood, biopsy and RP specimens Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery Ability to collect these samples for each participant will be assessed
Physical Fitness: Aerobic fitness using a submaximal graded exercise test Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery Comparison of baseline versus end of study aerobic fitness
Psychosocial: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P) Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery Comparison of questionnaire scores at baseline versus end of study
Psychosocial: Centre for Epidemiologic Studies Depression scale (CES-D) Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery Comparison of questionnaire scores at baseline versus end of study
Psychosocial: International Prostate Symptom Score (IPSS) Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery Comparison of questionnaire scores at baseline versus end of study
Trial Locations
- Locations (1)
Vancouver Prostate Centre
🇨🇦Vancouver, British Columbia, Canada