NCT06237179PHASE1, PHASE2Recruiting
Behavioral Exercise Training to Reduce Cardiovascular Disease Risk
Virginia Commonwealth University
Start Date
2/21/2024
Completion Date
1/31/2028
Summary
To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance \[6MWD\]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.
Eligibility Criteria
Age Range: 40 years to 85 years
Inclusion Criteria:
* Be diagnosed with stage II/III/IV prostate cancer
* Be currently undergoing treatment with ADT (intermittent or prolonged)
* Have completed local curative-intent treatment, including prostatectomy or definitive radiation;
* Be \>40 years of age up to 85;
* Be willing to sign an informed consent with HIPAA authorization form;
* Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation;
* Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview;
* Be without any serious medical condition that precludes safe participation in an exercise program;
* Speak English
Exclusion Criteria:
* Be unable to undergo MRI (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia);
* Have contraindications to exercise testing;
* Have pre-existing overt cardiovascular disease/heart failure;
* Active illness/infection;
* Hemoglobin \< 7.0 grams/dL
* Platelet count \< 10 x 109/L
Interventions
BEHAVIORAL
Exercise Training Intervention
BEHAVIORAL
Healthy Living Education
Conditions
Prostate CancerSupportive Care
Locations
Richmond Veterans Affairs Medical Center
Richmond, Virginia 23249
United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia 23298
United States