Exercise-induced Steroid Changes in Active Surveillance for Prostate Cancer
ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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+)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
High-Intensity Interval Training (HIIT) Exercise
BehavioralParticipants 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.
Treatment groups
49 Participants
are divided into 1 treatment groupGroup A: Home-Based High Intensity Interval Training (HIIT) Exercise Session + Saliva CollectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Protocol Completion Rate
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.
Time frame
From enrollment through completion of all study procedures (up to Day 1)Secondary outcomes
1
Acceptability of the Exercise and Saliva Collection Protocol
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.
Time frame
Immediately after protocol completion (Day 1)Sponsors and contacts
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Source ClinicalTrials.gov
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