Behavioral Exercise Training to Reduce Cardiovascular Disease Risk
Recruiting · NCT06237179 · Interventional (participants receive a specific treatment) · Lead sponsor: Virginia Commonwealth University
View the official record on ClinicalTrials.gov →Interventions studied
Exercise Training InterventionHealthy Living Education
What this trial is about
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.
Who can take part
Age range
40 Years to 85 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed across 1 US state.
- Richmond Veterans Affairs Medical Center - Richmond, Virginia, United States
- Virginia Commonwealth University Massey Cancer Center - Richmond, Virginia, United States