Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

{ "Behavioral Exercise Training for Prostate Cancer Patients", "This study is looking at whether a home-based exercise program, called Behavioral Exercise Training (ET), can improve how well men with prostate cancer can exercise. This is compared to a Healthy Living Education (HLE) program. We want to see if the exercise program helps men with prostate cancer who are receiving ADT (androgen deprivation therapy) improve their exercise capacity, measured by how much oxygen their body can use during exercise (VO2 peak) and how far they can walk in 6 minutes (6MWD). Men aged 40 to 85 with stage II, III, or IV prostate cancer who have completed local treatment and are currently on ADT may be able to join. The study aims to enroll 60 participants.", "design": "This interventional study plans to enroll 60 men. It compares two behavioral interventions: Exercise Training and Healthy Living Education.", "commitments": "Participants will take part in either a 12-week exercise training program or a healthy living education program. Measurements of exercise capacity will be taken at the beginning, 12 weeks, and 24 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for at least 24 weeks after starting the study interventions.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT06237179

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

Recruiting
PHASE1Ages 40–85InterventionalSupportive care
Virginia Commonwealth University
~60 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Exercise Training InterventionHealthy Living Education

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks
Measured over Baseline, 12 weeks, and 24 weeks
+1 more outcome measured
Prostate Cancer
Supportive Care
2 sites across 1 states
Virginia2
  • Alexander R Lucas, PhD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

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Eligibility criteria

Inclusion

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

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
  • Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeksBaseline, 12 weeks, and 24 weeks

    Exercise capacity will be measured by the maximal volume of oxygen utilization (VO2 peak) during a supine graded cardiopulmonary exercise test done in conjunction with cardiac magnetic resonance (exeCMR+CPET). VO2 will be measured in both relative (ml/kg/minute) and absolute (L/minute) terms.

  • Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeksBaseline, 12 weeks, and 24 weeks

    The distance walked in a sub-maximal 6-minute walk test (6MWD). 6MWD will be reported as meters walked (m).