Prostate Cancer
Conditions
Keywords
Prostate Cancer, Exercise, Steroids
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.
Interventions
Participants will complete a single supervised, online high intensity interval training (HIIT) exercise session lasting approximately 20 minutes. The exercise protocol consists of six 1-minute bouts with 1-minute rest intervals of moderate to high intensity bodyweight exercises, including movements such as lateral squats, wall pushups, and chair assisted sit to stands.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protocol Completion Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the Exercise and Saliva Collection Protocol | Immediately after protocol completion (Day 1) | Acceptability will be assessed using a participant-reported questionnaire adapted from the Theoretical Framework of Acceptability (TFA). The questionnaire evaluates acceptability across seven domains: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. Each domain is assessed using 1-2 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Domain scores are averaged, and an overall Acceptability Index score is calculated, with higher scores indicating greater acceptability. |
Countries
United States
Contacts
CONTACTNima Sharifi, MD
CONTACTElena Cortizas, MS
PRINCIPAL_INVESTIGATORNima Sharifi, MD
University of Miami
Outcome results
None listed