Exercise-induced Steroid Changes in Active Surveillance for Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Miami
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Protocol Completion Rate
Study Overview
Brief Summary
The purpose of this research study is to understand how a short session of a home-based bodyweight high-intensity interval training (HIIT) affects steroid hormone levels in men on active surveillance for low-grade prostate cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males 18 to 80 years old
- •Diagnosis of localized prostate cancer
- •Currently under active surveillance
- •Ability to perform moderate-to-high intensity physical activity as demonstrated by self-assessment using the Physical Activity Readiness Questionnaire (PAR-Q+)
- •Able to independently perform activities of daily living, without limitations in mobility
- •Ability to read, write, speak, and understand English
- •Able and willing to sign consent and comply with study requirements
Exclusion Criteria
- •Males currently receiving treatment for prostate cancer
- •Diagnosis of metastatic prostate cancer
- •Individuals with medical conditions contraindicating exercise
- •Uncontrolled cardiovascular or circulatory diseases, hypertension, and diabetes, as determined by the study doctor or treating physician
- •Ongoing use of medications affecting steroid metabolism
- •Unable to sign consent and/or comply with study requirements
Arms & Interventions
Home-Based High Intensity Interval Training (HIIT) Exercise Session + Saliva Collection
Participants will complete a single supervised, online high intensity interval training (HIIT) exercise session with six bouts of 1-minute exercises performed at a moderate-to-high intensity lasting approximately 20 minutes. Saliva samples will be collected immediately prior to exercise, immediately following exercise, and 15 minutes post-exercise.
Intervention: High-Intensity Interval Training (HIIT) Exercise (Behavioral)
Outcomes
Primary Outcomes
Protocol Completion Rate
Time Frame: From enrollment through completion of all study procedures (up to Day 1)
Protocol Completion Rate is defined as the proportion of enrolled participants who complete both the supervised home-based HIIT exercise session and return all scheduled saliva samples to the laboratory.
Secondary Outcomes
- Acceptability of the Exercise and Saliva Collection Protocol(Immediately after protocol completion (Day 1))
Investigators
Nima Sharifi
Professor and Scientific Director of the Desai Sethi Urology Institute
University of Miami