Behavioral Exercise Training to Reduce Cardiovascular Disease Risk
EXTRA-PC
3 other identifiers
interventional
60
1 country
2
Brief Summary
To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance \[6MWD\]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 prostate-cancer
Started Feb 2024
Typical duration for phase_1 prostate-cancer
2 active sites
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
January 4, 2024
CompletedFirst Posted
Study publicly available on registry
February 1, 2024
CompletedStudy Start
First participant enrolled
February 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2028
March 2, 2026
February 1, 2026
3.9 years
January 4, 2024
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks
Exercise capacity will be measured by the maximal volume of oxygen utilization (VO2 peak) during a supine graded cardiopulmonary exercise test done in conjunction with cardiac magnetic resonance (exeCMR+CPET). VO2 will be measured in both relative (ml/kg/minute) and absolute (L/minute) terms.
Baseline, 12 weeks, and 24 weeks
Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeks
The distance walked in a sub-maximal 6-minute walk test (6MWD). 6MWD will be reported as meters walked (m).
Baseline, 12 weeks, and 24 weeks
Secondary Outcomes (22)
Stroke Volume (SV) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
Baseline, 12 weeks
Left ventricular ejection fraction (LVEF) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
Baseline, 12 weeks
Cardiac output (CO) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
Baseline, 12 weeks
Arterial-venous oxygen (a-vO2) difference as a musculoskeletal determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
Baseline, 12 weeks
Change in lean body mass
Baseline, 12 weeks
- +17 more secondary outcomes
Study Arms (2)
Exercise Training Intervention
EXPERIMENTALThe exercise program (ET) is tailored to each participant depending on his initial functional capacity, cardiorespiratory fitness and strength, to achieve ≥150 moderate to vigorous physical activity
Healthy Living Education Control
ACTIVE COMPARATOREducational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm.
Interventions
5.1. The behavioral ET and HLE interventions will be delivered over 12 weeks. Before starting the study, men will be asked to attend one (1) in-person small group orientation to provide an overview of each intervention arm, familiarize them with web-based and smartphone applications or hard copy manuals for delivery of intervention content, exercise logs, resistance bands, and equipment for strength training.
During the initial 12 weeks of the study, men randomized to the HLE group will receive educational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm.
Eligibility Criteria
You may qualify if:
- Be diagnosed with stage II/III/IV prostate cancer
- Be currently undergoing treatment with ADT (intermittent or prolonged)
- Have completed local curative-intent treatment, including prostatectomy or definitive radiation;
- Be \>40 years of age up to 85;
- Be willing to sign an informed consent with HIPAA authorization form;
- Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation;
- Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview;
- Be without any serious medical condition that precludes safe participation in an exercise program;
- Speak English
You may not qualify if:
- Be unable to undergo MRI (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia);
- Have contraindications to exercise testing;
- Have pre-existing overt cardiovascular disease/heart failure;
- Active illness/infection;
- Hemoglobin \< 7.0 grams/dL
- Platelet count \< 10 x 109/L
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Richmond Veterans Affairs Medical Center
Richmond, Virginia, 23249, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander R Lucas, PhD
Virginia Commonwealth University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2024
First Posted
February 1, 2024
Study Start
February 21, 2024
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
January 31, 2028
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share