Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy
1 other identifier
interventional
62
1 country
1
Brief Summary
The purpose of this research is to determine whether a 16-week culturally tailored, technology-based, aerobic and resistance exercise intervention improves cardiovascular risk factors in Black men diagnosed with prostate cancer and are undergoing androgen deprivation therapy (ADT), and whether it will also improve physical fitness and function, body composition, and outcomes such as quality of life, cancer symptoms, and self-esteem. Participants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedStudy Start
First participant enrolled
August 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 22, 2026
January 1, 2026
3.9 years
March 16, 2022
January 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiovascular disease risk factors
Framingham Risk Score, an established comprehensive tool for evaluating the risk of developing cardiovascular disease using blood samples (i.e., low-density lipoprotein-cholesterol \[LDL-C\] or total cholesterol \[TC\], high-density lipoprotein-cholesterol \[HDL-C\]), demographic and medical profiles , and lifestyle behaviors (i.e., age, blood pressure, and diabetic and smoking status). The score ranges from -4 to 36 and the 10-year cardiovascular risk will be calculated accordingly (a higher score indicates a higher risk of cardiovascular disease).
baseline to 4 months
Secondary Outcomes (15)
Cardiorespiratory capacity
baseline to 4 months
Muscular strength
baseline to 4 months
Short Physical Performance Battery (SPPB)
baseline to 4 months
Timed-Up-and-Go (TUG)
baseline to 4 months
Hand grip strength
baseline to 4 months
- +10 more secondary outcomes
Study Arms (2)
Aerobic and resistance exercise
EXPERIMENTALVirtually supervised 16-week aerobic and resistance exercise performed at home via Zoom. The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer.
Usual care
ACTIVE COMPARATORMaintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise program after 16 weeks.
Interventions
Maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise (aerobic and resistance exercise) program after 16 weeks.
Perform exercise at home with virtual supervision, including aerobic exercise (e.g.,cycling), which can improve cardiovascular (heart) and lung function, and resistance exercise (e.g., dumbbell lifting and using resistance band. The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer
Eligibility Criteria
You may qualify if:
- Patients must meet all criteria to be eligible, including travel to Dana-Farber Cancer Institute (DFCI) to collect research data to address the study question.
- Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease
- Histologically diagnosed of localized or metastatic prostate cancer
- Have been receiving androgen deprivation therapy (ADT) (i.e., luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist and/or androgen receptor \[AR\] agonist/antagonist) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment
- Self-identify as Black
- Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist
- Are without medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases
- Speak English and/or Spanish
- Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week
- Willing to travel to DFCI for necessary data collection
- Ability to communicate and complete written forms in English and/or Spanish
You may not qualify if:
- Are not receiving ADT (i.e., LHRH agonist/antagonist and/or AR agonist/antagonist)
- Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise
- Are not English or Spanish speaking
- Patients with secondary diagnosis (with the exception of basal cell carcinoma)
- Participate in more than 60 minutes of moderate or vigorous structured exercise/week
- Unable to travel to DFCI for necessary data collection
- May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizercollaborator
- Prostate Cancer Foundationcollaborator
- Dana-Farber Cancer Institutelead
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Related Publications (1)
Kang DW, Ficarra S, Wilson RL, Morgans AK, Nguyen PL, Rebbeck TR, Einstein DJ, Uno H, Mossanen M, Hill DM, Gonzalo-Encabo P, Norris MK, Gardiner J, Tjogas D, Greer J, Dieli-Conwright CM. Exercise to enhance cardiovascular health among black men with prostate cancer with androgen deprivation therapy (the POWER trial): A study protocol. Contemp Clin Trials. 2025 Aug;155:107973. doi: 10.1016/j.cct.2025.107973. Epub 2025 May 30.
PMID: 40451460DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina C Dieli-Conwright, PhD, MPH
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 16, 2022
First Posted
April 14, 2022
Study Start
August 11, 2022
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.