Health TrialsbyHealthPanel

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

ConditionsProstate CancerSupportive Care
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age40-85
SponsorVirginia Commonwealth University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise Training Intervention

    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

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Exercise Training InterventionExperimental treatment 1 intervention
Group B: Healthy Living Education ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 12 weeks, and 24 weeks
2

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).

Time frame
Baseline, 12 weeks, and 24 weeks

Secondary outcomes

1

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

By measuring resting and exercise -associated left ventricular (LV) end-diastolic (EDV) and end-systolic volumes (ESV) we will calculate stroke volume (SV) in milliliters/beat (ml). SV = EDV - ESV

Time frame
Baseline, 12 weeks
2

Left ventricular ejection fraction (LVEF) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.

By measuring resting and exercise-associated stroke volumes (SV) as a proportion of end-diastolic volumes (EDV) we will calculate left ventricular ejection fraction (%). LVEF = SV/EDV

Time frame
Baseline, 12 weeks
3

Cardiac output (CO) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.

By measuring resting and exercise-associated stroke volume (SV) and the heart rate (HR) in conjunction with image acquisition we will calculate cardiac output in liters per minute (L/min). CO = SV x HR

Time frame
Baseline, 12 weeks
4

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.

From the exercise tests we will calculate a-vO2 difference using the FICK equation. The difference in oxygen saturation between the venous circulation and the arterial circulation will be reported in milliliters (ml) and also expressed as ml/100ml of blood (%) a-vO2 = VO2 / CO

Time frame
Baseline, 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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