NCT06237179 Behavioral Exercise Training to Reduce Cardiovascular Disease Risk
| NCT ID | NCT06237179 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Virginia Commonwealth University |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-02-21 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2024-02-21 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Alexander R Lucas, PhD
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT06237179 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 85 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06237179 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06237179 currently recruiting?
Yes, NCT06237179 is actively recruiting participants. Contact the research team at Alexander.Lucas@vcuhealth.org for enrollment information.
Where is the NCT06237179 trial being conducted?
This trial is being conducted at Richmond, United States, Richmond, United States.
Who is sponsoring the NCT06237179 clinical trial?
NCT06237179 is sponsored by Virginia Commonwealth University. The principal investigator is Alexander R Lucas, PhD at Virginia Commonwealth University. The trial plans to enroll 60 participants.
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