Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

NCT ID: NCT06237179

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-21

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Supportive Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise Training Intervention

The 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

Group Type EXPERIMENTAL

Exercise Training Intervention

Intervention Type BEHAVIORAL

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.

Healthy Living Education Control

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.

Group Type ACTIVE_COMPARATOR

Healthy Living Education

Intervention Type BEHAVIORAL

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.

Interventions

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Exercise Training Intervention

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.

Intervention Type BEHAVIORAL

Healthy Living Education

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Behavioral, Exercise Training

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander R Lucas, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Richmond Veterans Affairs Medical Center

Richmond, Virginia, United States

Site Status NOT_YET_RECRUITING

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alexander R Lucas, PhD

Role: CONTACT

804 628-6610

Alexandra Marshall, MS

Role: CONTACT

804 628-1215

Facility Contacts

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Alexander R Lucas, PhD

Role: primary

804-628-6610

Alexandra L Marshall, MS

Role: backup

804 628-1215

Alexandra Marshall

Role: primary

Alexander Lucas, PhD

Role: backup

804-628-6610

Other Identifiers

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HM20028583

Identifier Type: OTHER

Identifier Source: secondary_id

1K01HL161419-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-23-20934

Identifier Type: -

Identifier Source: org_study_id

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