High-Intensity Interval Training Exercise ProgramHigh-Intensity Interval Training Exercise Program
High-Intensity Interval Training Exercise Program: Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor.
High-Intensity Interval Training Exercise Program: (Optionally) Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor.
Study summary
The purpose of this study is to determine whether a 12-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among men with prostate cancer at high-risk of progression undergoing active surveillance.
The name of the study intervention involved in this study is:
Aerobic high-intensity interval training (HIIT) (training exercise intervention)
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age ≥18 years.
* Histologically diagnosed with localized prostate cancer.
* Initiating or undergoing active surveillance.
* Having a higher risk of progression, defined as meeting one or more of the following: (1) favorable- intermediate risk prostate tumor at diagnosis, (2) obesity (body mass index ≥ 30), and/or (3) self- identified as Black or African American.
* No plans for invasive treatment for their prostate cancer in the 12 weeks following the time of enrollment.
* Ability to understand and willingness to provide informed consent.
Exclusion Criteria:
* Received any invasive curative-intent treatment for prostate cancer, including surgery, chemotherapy, radiation therapy, and hormonal therapy.
* Patients with metastasis and/or other active malignancies (except basal cell carcinoma) and/or receiving treatment for those malignancies.
* Participating in any (\>0 min/week) high-intensity exercise at the time of recruitment.
* Having chronic medical conditions that are clinically unstable or uncontrolled with medications, deemed high-risk for exercise. These include but are not limited to unstable cardiac diseases, uncontrolled diabetes, and bone metastases with imminent risk of fracture.
* Having a high risk for noncompliance with study procedures. This will be determined by the study team based on the history of missed oncology appointments (i.e., ≥3 no-shows in 6 months) and poor responsiveness during recruitment (i.e., ≥3 unreturned contacts).
* Patients who are non-English speaking and unable to complete the participant surveys.
Primary outcome measure(s)
Prostate-Specific Antigen (PSA) Level — Baseline (Week 1) and post-intervention (Week 14) The primary outcome is the between-group difference in prostate-specific antigen (PSA) levels post-intervention. Analysis of covariance will be used to detect the difference adjusting for baseline values of the outcome and other covariates.
Trial sites (4)
Facility
City
Region
Status
Beth Israel Deaconess Medical Center
Boston
Massachusetts
Completed
Brigham and Women's Hospital
Boston
Massachusetts
Completed
Dana-Farber Cancer Institute
Boston
Massachusetts
Completed
Fred Hutch/University of Washington Cancer Consortium
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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