Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

Clinicaltrials.gov ID: NCT06237179

Status RECRUITING

Phase PHASE1, PHASE2

Age 40 - 85 Years

Enrollments 60

Conditions

Prostate Cancer, Supportive Care

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.

Locations

1 location Found with status Recruiting

Status

RECRUITING

Contact Person

Alexandra Marshall
[email protected]

Principal Investigator

Alexander R Lucas, PhD

Eligibility Criteria

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

Study Plan

Exercise Training Intervention

EXPERIMENTAL

The exercise program (ET) is tailored to each participant depending on his initial functional capacity, cardiorespiratory fitness and strength, to achieve u2265150 moderate to vigorous physical activity

BEHAVIORAL:
Exercise Training Intervention
Description:
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

ACTIVE_COMPARATOR

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.

BEHAVIORAL:
Healthy Living Education
Description:
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.

Outcome Measures

Primary Outcome Measures

Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks

Time Frame: Baseline, 12 weeks, and 24 weeks

Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeks

Time Frame: Baseline, 12 weeks, and 24 weeks

Secondary Outcome Measures

Stroke Volume (SV) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Time Frame: Baseline, 12 weeks

Change in lean body mass

Time Frame: Baseline, 12 weeks