Clinical trial NCT06237179: Behavioral Exercise Training to Reduce Cardiovascular Disease Risk
Official title: Behavioral Exercise Training to Reduce Cardiovascular Disease Risk in Men Undergoing Androgen Deprivation Therapy (EXTRA-PC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Supportive Care
Keywords: Prostate Cancer
Supportive Care
Exercise
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-02-01
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeks
timeFrame: Baseline, 12 weeks, and 24 weeks
Secondary outcomes:
measure: Stroke Volume (SV) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
timeFrame: Baseline, 12 weeks
measure: Left ventricular ejection fraction (LVEF) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
timeFrame: Baseline, 12 weeks
measure: Cardiac output (CO) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
timeFrame: Baseline, 12 weeks
measure: 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.
timeFrame: Baseline, 12 weeks
measure: Change in lean body mass
timeFrame: Baseline, 12 weeks
measure: Change in fat mass
timeFrame: Baseline, 12 weeks
measure: Neighborhood Environment & Walkability Survey (NEWS-A)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in physical activity assessed with the Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in physical activity assessed with Accelerometry
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in self-efficacy to navigate barriers to engaging in exercise
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in self-efficacy to walk for increasing periods of time.
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in Functional Assessment of Cancer Therapy - Prostate (FACT-P) scores
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in health-related quality of life (SF-36) scores
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in fatigue measured with the patient reported outcomes measurement information system (PROMIS) - Fatigue scores
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in physical function measured with the patient reported outcomes measurement information system (PROMIS) - Physical Functioning scores
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in sleep disturbance measured with the patient reported outcomes measurement information system (PROMIS) - Sleep Disturbance scores
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in depressive symptoms measured with the patient reported outcomes measurement information system (PROMIS) - Depression scores
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in anxiety measured with the patient reported outcomes measurement information system (PROMIS) - Anxiety scores
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in emotional distress measured with the patient reported outcomes measurement information system (PROMIS) - Emotional Distress scores
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in fatigue measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in perceived stress as measured with Cohen's perceived stress scale (PSS)
timeFrame: Baseline, 12 weeks, 24 weeks
measure: Change in physical function assessed with the Short Physical Performance Battery (SPPB)
timeFrame: Baseline, 12 weeks, 24 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Richmond Veterans Affairs Medical Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Alexander R Lucas, PhD
role: PRINCIPAL_INVESTIGATOR
References: