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NCT Number: NCT06237179

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

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.

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Key information

Age range

40 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Richmond Veterans Affairs Medical Center, Richmond, Virginia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Behavioral, Exercise 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.

Primary outcomes

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

    Time frame: Baseline, 12 weeks, and 24 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.

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

    Time frame: Baseline, 12 weeks, and 24 weeks

    The distance walked in a sub-maximal 6-minute walk test (6MWD). 6MWD will be reported as meters walked (m).

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.

    Time frame: Baseline, 12 weeks

    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

  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.

    Time frame: Baseline, 12 weeks

    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

  3. 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

    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

  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.

    Time frame: Baseline, 12 weeks

    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

  5. Change in lean body mass

    Time frame: Baseline, 12 weeks

    We will conduct body composition assessments using bioelectrical impedance analysis (BIA) and a Dual Energy X-Ray Absorptiometry (DXA) scan. We will use dual X-ray absorptiometry (DEXA) to assess whole body composition for lean body mass.

    Lean body mass will be reported as kilograms (kg)

  6. Change in fat mass

    Time frame: Baseline, 12 weeks

    We will conduct body composition assessments using bioelectrical impedance analysis (BIA) and a Dual Energy X-Ray Absorptiometry (DXA) scan. We will use dual X-ray absorptiometry (DEXA) to assess whole body composition for fat mass as well as distribution patterns of adiposity, e.g., visceral adipose tissue.

    Fat mass and visceral fat mass will be reported in kilograms (kg) and body fat percentage will be reported as fat mass / body mass (%)

  7. Neighborhood Environment & Walkability Survey (NEWS-A)

    Time frame: Baseline, 12 weeks, 24 weeks

    NEWS-A is a validated self-reported survey used to assess factors that are correlates or determinants of participants ability to engage in physical activity in their neighborhoods. For example, higher walkability is determined by availability of sidewalks and access to nearby facilities.

  8. Change in physical activity assessed with the Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Time frame: Baseline, 12 weeks, 24 weeks

    GLTEQ is a self-report survey to determine the level typical activity a participant engages in each week. Higher scores on the index indicate more activity.

  9. Change in physical activity assessed with Accelerometry

    Time frame: Baseline, 12 weeks, 24 weeks

    The ActivPAL and Actigraph accelerometers provide an objective assessment of sedentary sitting time and increasing intensities of physical activity in minutes per week

  10. Change in self-efficacy to navigate barriers to engaging in exercise

    Time frame: Baseline, 12 weeks, 24 weeks

    A self report of self-efficacy to engage in exercise or physical activity under different challenging conditions such as when experiencing fatigue. Higher scores indicate increased confidence to navigate barriers.

  11. Change in self-efficacy to walk for increasing periods of time.

    Time frame: Baseline, 12 weeks, 24 weeks

    A self report of self-efficacy to engage in walking for an increasing period of time. Higher scores indicate increased confidence to walk for a longer periods of time without resting.

  12. Change in Functional Assessment of Cancer Therapy - Prostate (FACT-P) scores

    Time frame: Baseline, 12 weeks, 24 weeks

    FACT-P is a validated self report measures of different domains of quality of life that are important for men who have been diagnosed with prostate cancer. Subscale scores can be assessed to gauge functional wellbeing, physical wellbeing, social wellbeing and emotional wellbeing as well as prostate specific wellbeing. Higher scores indicate a higher quality of life on overall and sub scales.

  13. Change in health-related quality of life (SF-36) scores

    Time frame: Baseline, 12 weeks, 24 weeks

    SF-36 (RAND) is a validated self report measure of different domains of health-related quality of life that are important for adults. Higher scores indicate a higher health-related quality of life .

  14. Change in fatigue measured with the patient reported outcomes measurement information system (PROMIS) - Fatigue scores

    Time frame: Baseline, 12 weeks, 24 weeks

    PROMIS - Fatigue is a validated self-report measure of fatigue among patients diagnosed with cancer and higher scores indicate a lower level of fatigue.

  15. Change in physical function measured with the patient reported outcomes measurement information system (PROMIS) - Physical Functioning scores

    Time frame: Baseline, 12 weeks, 24 weeks

    PROMIS - Physical Functioning is a validated self-report measure of physical functioning among patients diagnosed with cancer and higher scores indicate a better function.

  16. Change in sleep disturbance measured with the patient reported outcomes measurement information system (PROMIS) - Sleep Disturbance scores

    Time frame: Baseline, 12 weeks, 24 weeks

    PROMIS - Sleep Disturbance is a validated self-report measure of sleep disturbance among patients diagnosed with cancer and higher scores indicate less sleep disruption.

  17. Change in depressive symptoms measured with the patient reported outcomes measurement information system (PROMIS) - Depression scores

    Time frame: Baseline, 12 weeks, 24 weeks

    PROMIS - Depression is a validated self-report measure of depressive symptoms among patients diagnosed with cancer and higher scores indicate less symptoms.

  18. Change in anxiety measured with the patient reported outcomes measurement information system (PROMIS) - Anxiety scores

    Time frame: Baseline, 12 weeks, 24 weeks

    PROMIS - Anxiety is a validated self-report measure of depressive symptoms among patients diagnosed with cancer and higher scores indicate less symptoms.

  19. Change in emotional distress measured with the patient reported outcomes measurement information system (PROMIS) - Emotional Distress scores

    Time frame: Baseline, 12 weeks, 24 weeks

    PROMIS - Anxiety is a validated self-report measure of depressive symptoms among patients diagnosed with cancer and higher scores indicate less symptoms.

  20. Change in fatigue measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale

    Time frame: Baseline, 12 weeks, 24 weeks

    FACUT-F is a validated self-report measure of fatigue among patients undergoing treatment for a chronic illness and higher scores indicate less fatigue.

  21. Change in perceived stress as measured with Cohen's perceived stress scale (PSS)

    Time frame: Baseline, 12 weeks, 24 weeks

    PSS is a validated self-report measure of perceived stress and higher scores indicate more perceived stress.

  22. Change in physical function assessed with the Short Physical Performance Battery (SPPB)

    Time frame: Baseline, 12 weeks, 24 weeks

    SPPB is a validated objective assessment of 3 domains of physical function that includes gait speed, grip strength and time taken to stand from a chair 5 times. Each down is scored on a scale of 0-4 with a total score summed from each domain. A higher score is indicative of better functioning.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander R Lucas, PhD

CONTACT

[email protected]

804 628-6610

Alexandra Marshall, MS

CONTACT

[email protected]

804 628-1215

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: EXTRA-PC

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 1, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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