Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

Phase 1

Recruiting

• Conditions: Supportive Care; Prostate Cancer
• Interventions: Behavioral: Exercise Training Intervention; Behavioral: Healthy Living Education

• Registration Number: NCT06237179
• Lead Sponsor: Virginia Commonwealth University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-31
• Status Verified: 2024-02
• Study First Posted: 2024-02-01
• Study Start: 2024-02-21
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23
• Primary Completion: 2028-01-31
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Training Intervention	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
Healthy Living Education Control	Healthy Living Education	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

Name	Time	Method
Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks	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.
Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeks	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 Outcome Measures

Name	Time	Method
Change in fat mass	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 (%)
Change in physical activity assessed with the Godin Leisure-Time Exercise Questionnaire (GLTEQ)	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.
Left ventricular ejection fraction (LVEF) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.	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
Cardiac output (CO) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.	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
Neighborhood Environment & Walkability Survey (NEWS-A)	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.
Change in physical function measured with the patient reported outcomes measurement information system (PROMIS) - Physical Functioning scores	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.
Change in depressive symptoms measured with the patient reported outcomes measurement information system (PROMIS) - Depression scores	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.
Stroke Volume (SV) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.	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
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.	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
Change in self-efficacy to walk for increasing periods of time.	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.
Change in emotional distress measured with the patient reported outcomes measurement information system (PROMIS) - Emotional Distress scores	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.
Change in fatigue measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale	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.
Change in lean body mass	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)
Change in self-efficacy to navigate barriers to engaging in exercise	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.
Change in Functional Assessment of Cancer Therapy - Prostate (FACT-P) scores	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.
Change in fatigue measured with the patient reported outcomes measurement information system (PROMIS) - Fatigue scores	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.
Change in anxiety measured with the patient reported outcomes measurement information system (PROMIS) - Anxiety scores	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.
Change in physical activity assessed with Accelerometry	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
Change in health-related quality of life (SF-36) scores	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 .
Change in sleep disturbance measured with the patient reported outcomes measurement information system (PROMIS) - Sleep Disturbance scores	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.
Change in perceived stress as measured with Cohen's perceived stress scale (PSS)	Baseline, 12 weeks, 24 weeks	PSS is a validated self-report measure of perceived stress and higher scores indicate more perceived stress.
Change in physical function assessed with the Short Physical Performance Battery (SPPB)	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.

Trial Locations

Locations (2)

Richmond Veterans Affairs Medical Center; 🇺🇸 Richmond, Virginia, United States

Virginia Commonwealth University Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States