Remotely Monitored Exercise Interventions in Patients With mCSPC Undergoing ADT (Prostate 006)

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Paul Viscuse
Study ID
NCT06429813
Status
Recruiting
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Conditions

  • Castrate Sensitive Prostate Cancer
  • Metastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Home-Based Exercise Intervention - Walking — BEHAVIORAL
    30 minutes of walking or light jogging a day at a moderate intensity for 30 minutes a day, 5 days a week for 12 weeks
  • Home-Based Exercise Intervention - HIIT Cycling — BEHAVIORAL
    Four, 4 minute high intensity intervals of exercise, separated by 3 minutes of lower intensity exercise + a 10 minute warm up and 5 minute cool down for 40 minutes a day, 3 days a week for 12 weeks

Study Details

This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B). The study will enroll 24 patients who are starting ADT (Androgen Deprivation Therapy)/ARSI (Androgen-Receptor Signaling Inhibitors) therapy for newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC). All participants will be asked to complete 1-2 training sessions at UVA prior to starting the exercise. All participants will be asked to complete aerobic and strength testing before and after the exercise program. Participants will be asked to answer questionnaires throughout the program. The at-home exercise will last for 12 weeks.

Key Dates

Start date
Jul 26, 2024
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Nov 30, 2027

Study Design

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

Arms

  • Experimental: Arm A
    HIIT Cycling Intervention
  • Experimental: Arm B
    Walking Intervention

Primary Outcome Measure

Number of participants who complete the post-intervention follow-up assessment [ Time Frame: 14 weeks from the start of the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908
Steven Goff
[email protected]
434-806-1357

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By research site
University of Virginia· Charlottesville, VA

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