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Recruiting NCT06237179

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

Phase I / Phase II Interventional Prostate Cancer Supportive Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise Training Intervention, Healthy Living Education.
Who it may be relevant to
Registry conditions: Prostate Cancer, Supportive Care. Basic parameters: 40 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk in Men Undergoing Androgen Deprivation Therapy (EXTRA-PC)

Overview

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.

Interventions

  • Behavioral 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.
  • 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.

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 (12)
  • 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]
  • Change in fat mass [Time frame: Baseline, 12 weeks]
  • Neighborhood Environment & Walkability Survey (NEWS-A) [Time frame: Baseline, 12 weeks, 24 weeks]
  • Change in physical activity assessed with the Godin Leisure-Time Exercise Questionnaire (GLTEQ) [Time frame: Baseline, 12 weeks, 24 weeks]
  • Change in physical activity assessed with Accelerometry [Time frame: Baseline, 12 weeks, 24 weeks]
  • Change in self-efficacy to navigate barriers to engaging in exercise [Time frame: Baseline, 12 weeks, 24 weeks]
  • Change in self-efficacy to walk for increasing periods of time. [Time frame: Baseline, 12 weeks, 24 weeks]
  • Change in Functional Assessment of Cancer Therapy - Prostate (FACT-P) scores [Time frame: Baseline, 12 weeks, 24 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 2 centers
  • Richmond Veterans Affairs Medical Center — Richmond
  • Virginia Commonwealth University Massey Cancer Center — Richmond

Identifiers

NCT: NCT06237179 · MCC-23-20934 · HM20028583 · 1K01HL161419-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗