Behavioral Exercise Training to Reduce Cardiovascular Disease Risk
Behavioral Exercise Training to Reduce Cardiovascular Disease Risk in Men Undergoing Androgen Deprivation Therapy (EXTRA-PC)
Virginia Commonwealth University
60 participants
Feb 21, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria6
- 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
5.1. The behavioral ET and HLE interventions will be delivered over 12 weeks. Before starting the study, men will be asked to attend one (1) in-person small group orientation to provide an overview of each intervention arm, familiarize them with web-based and smartphone applications or hard copy manuals for delivery of intervention content, exercise logs, resistance bands, and equipment for strength training.
During the initial 12 weeks of the study, men randomized to the HLE group will receive educational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06237179