Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT06237179
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Exercise Training Intervention — BEHAVIORAL
    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.
  • Healthy Living Education — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 21, 2024
Status verified
Feb 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Exercise Training Intervention
    The exercise program (ET) is tailored to each participant depending on his initial functional capacity, cardiorespiratory fitness and strength, to achieve ≥150 moderate to vigorous physical activity
  • Active Comparator: Healthy Living Education Control
    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.

Primary Outcome Measure

Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks [ Time Frame: Baseline, 12 weeks, and 24 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Richmond Veterans Affairs Medical CenterRichmondVirginia23249
Alexander R Lucas, PhD
[email protected]
804-628-6610
Alexandra L Marshall, MS
[email protected]
804 628-1215
Alexander R Lucas, PhD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298
Alexandra Marshall
[email protected]
Alexander Lucas, PhD
[email protected]
804-628-6610
Alexander Lucas, Ph.D (PRINCIPAL_INVESTIGATOR)

Find similar trials in Richmond, VA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Richmond Veterans Affairs Medical Center· Richmond, VAVirginia Commonwealth University Massey Cancer Center· Richmond, VA

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