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High-Intensity Functional Training vs. Moderate-Intensity Continuous Training in Cardiovascular Disease Patients

4 listopada 2026 zaktualizowane przez: Arlette Perry, University of Miami

A Comparison of Two Exercise Protocols on Vascular Function and Subclinical Predictors of Cardiovascular Risk in Patients With Cardiovascular Disease

The purpose of this study is to compare two exercise programs with a control group to see how they affect blood vessel health in people with cardiovascular disease.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

200

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Arlette Perry, PhD
  • Numer telefonu: 305-898-7370
  • E-mail: aperry@miami.edu

Lokalizacje studiów

  • Stany Zjednoczone
    • Florida
      • Coral Gables, Florida, Stany Zjednoczone, 33146
        • Merrick Building, University of Miami
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

45 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Age: ≥45 years.

  • Diagnosis of cardiovascular disease (CVD): Clinically documented by a licensed clinician in the medical record, including at least one of the following:

    1. Prior myocardial infarction (MI) or angiographically confirmed coronary artery disease (CAD).
    2. Stable angina, prior PCI/CABG, or documented myocardial ischemia on stress testing.

  • Clinical stability: On stable guideline-directed medical therapy (GDMT) for ≥2 weeks and no hospitalizations for acute cardiovascular events within the past 4 weeks.

  • For post-myocardial infarction (MI) participants: ≥4 weeks since index MI and clinically stable without ongoing ischemia.

  • Capacity and consent: Able to understand the study procedures and provide written informed consent (with interpreter support if needed).

  • Procedural feasibility: Able to undergo vascular ultrasound testing (e.g., flow-mediated dilation), pulse wave analysis/velocity, standard transthoracic echocardiography, body composition assessment, venipuncture for biomarkers, and submaximal fitness tests (e.g., 6-minute walk and handgrip).

  • Participants should be able to understand English or bring someone who speaks and understands English.

Exclusion Criteria:

  • Individuals who are not yet adults (infants, children, teenagers)

  • Pregnant women

  • Prisoners

  • Acute/unstable conditions (past 4 weeks): Acute coronary syndrome, decompensated heart failure, sustained ventricular arrhythmias, syncope of cardiac origin, or stroke/Transient Ischemic Attack (TIA).

  • Hemodynamic instability or severe uncontrolled disease:

    1. Resting Systolic Blood Pressure (SBP) ≥180 mmHg or Diastolic Blood Pressure (DBP) ≥110 mmHg at screening or visit day despite medication
    2. Oxygen saturation <90% at rest on room air
    3. Active myocarditis
    4. Active pericarditis

  • Valvular/structural heart disease likely to confound measures or increase risk: Severe aortic stenosis or severe valvular regurgitation; obstructive hypertrophic cardiomyopathy with resting Left Ventricular Outflow Tract (LVOT) gradient >30 mmHg; restrictive or constrictive physiology chronic or acute requiring urgent intervention

  • Arrhythmias that preclude accurate testing or pose risk: Rapid, uncontrolled atrial fibrillation/flutter (ventricular rate persistently >110 bpm at rest) or frequent ectopy that prevents reliable Doppler/strain or pulse-wave measurements. (Rate-controlled Atrial fibrillation (AF) is allowable if measurements are technically feasible.)

  • Recent major procedures: Major surgery, Percutaneous Coronary Intervention (PCI), or Coronary Artery Bypass Grafting (CABG) within the past 4 weeks (CABG within 8 weeks) unless cleared by the treating physician and study PI.

  • Severe non-cardiac comorbidities likely to confound vascular/endothelial markers or limit participation:

  • Active systemic infection or fever within 7 days; active autoimmune/inflammatory disease flare requiring escalation of immunosuppression in past 8 weeks.

  • Advanced renal dysfunction (eGFR <30 mL/min/1.73 m² or dialysis) or decompensated cirrhosis (Child-Pugh C).

  • Active malignancy receiving cytotoxic chemotherapy or thoracic radiation within the past 6 months (hormonal therapy permitted).

  • Contraindications to phlebotomy or vascular testing: Known severe bleeding diathesis or platelet count <50,000/μL; current therapeutic anticoagulation is permitted if clinically stable and venipuncture is not contraindicated by the treating clinician.

  • Peripheral vascular disease

  • Musculoskeletal/neurologic limitations preventing fitness testing (e.g., non-weight-bearing status, unstable orthopedic injuries) without safe alternatives.

  • Substance use or cognitive/psychiatric conditions that, in the investigator's judgment, would impair consent, adherence to pre-test restrictions, or completion of study procedures.

  • Current participation in another interventional trial that could affect vascular/endothelial outcomes (observational registries permitted).

  • Active participation in sports or exercise with 24-48 hours of testing.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: High-intensity Functional Training (HIFT) Group

Participants assigned to the HIFT group will perform supervised high-intensity functional training using scalable, multi-joint functional movements three days per week for a total of 12 weeks.
Behawioralne: High-Intensity Functional Training (HIFT)

Participants will complete supervised high-intensity functional training consisting of scalable, multi-joint functional movements. Exercise sessions will occur approximately 3 times per week for 12 weeks and will last 40 to 60 minutes, including warm-up and cool-down. Examples of activities may include body-weight exercises, resistance training, step-ups, sit-to-stand movements, squats, lunges, modified push-ups, and core exercises.
Eksperymentalny: Moderate-Intensity Continuous Training (MICT) Group

Participants assigned to the MICT group will perform supervised moderate-intensity continuous aerobic exercise three days per week for a total of 12 weeks.
Behawioralne: Moderate-Intensity Continuous Training (MICT)

Participants will complete supervised moderate-intensity continuous aerobic exercise. Exercise sessions will occur approximately 3 times per week for 12 weeks and will last 40 to 60 minutes, including warm-up and cool-down. Examples of activities may include treadmill walking, cycling, elliptical exercise, or step-based aerobic activity.
Brak interwencji: Control Group

Participants in this group will be asked to maintain their usual diet, usual medical care, physical activity, and lifestyle behaviors.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Carotid-Femoral Pulse Wave Velocity (cfPWV)
Ramy czasowe: Baseline and Week 12 (post-intervention)

Carotid-Femoral Pulse Wave Velocity (cfPWV) will be measured in meters per second (m/s) as an indicator of arterial stiffness. Measurement will be obtained using the SphygmoCor XCEL device (AtCor Medical) with upper arm and thigh cuffs with carotid artery applanation tonometry to assess pulse wave transit time.
Baseline and Week 12 (post-intervention)
Change in Central Augmentation Index (cAIx)
Ramy czasowe: Baseline and Week 12 (post-intervention)

Central Augmentation Index (cAIx) expressed as a percentage (%) will be assessed using the SphygmoCor XCEL device via pulse wave analysis of the central arterial waveform derived from carotid artery tonometry and peripheral blood pressure measurements.
Baseline and Week 12 (post-intervention)
Change in Mean Arterial Pressure (MAP)
Ramy czasowe: Baseline and Week 12 (post-intervention)

Mean Arterial Pressure (MAP) measured in millimeters of mercury (mmHg), will be estimated using the SphygmoCor XCEL device based on an algorithm derived from peripherally measured blood pressure obtained from an automated upper arm cuff.
Baseline and Week 12 (post-intervention)
Percent Change in Flow-Mediated Dilation (FMD)
Ramy czasowe: Baseline and Week 12 (post-intervention)

Flow-Mediated Dilation (FMD) will be measured using a Philips Affiniti 50 ultrasound system. FMD will be expressed as percent (%) change in brachial artery diameter from pre-occlusion baseline to peak dilation following a 5-minute forearm occlusion.
Baseline and Week 12 (post-intervention)
Change in Carotid Intima-Media Thickness (cIMT)
Ramy czasowe: Baseline and Week 12 (post-intervention)

Carotid Intima-Media Thickness (cIMT), measured in millimeters (mm), will be assessed using a Philips Affiniti 50 ultrasound system. High-resolution B-mode images of the distal common carotid artery will be acquired, and mean wall thickness will be calculated from standardized image segments of the left and right carotid arteries.
Baseline and Week 12 (post-intervention)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Body Mass Index (BMI)
Ramy czasowe: Baseline and Week 12 (post-intervention)

Change in body mass index (BMI), measured in kilograms per square meter (kg/m²), will be calculated as weight in kilograms divided by height in meters squared.
Baseline and Week 12 (post-intervention)
Change in Waist Circumference
Ramy czasowe: Baseline and Week 12 (post-intervention)

Change in waist circumference, measured in centimeters (cm), will be assessed using a standardized measuring tape.
Baseline and Week 12 (post-intervention)
Change in Body Fat Percentage
Ramy czasowe: Baseline and Week 12 (post-intervention)

Change in body fat percentage, measured as a percentage (%), will be assessed using the SECA mBCA bioelectrical impedance analysis system.
Baseline and Week 12 (post-intervention)
Change in Skeletal Muscle Mass
Ramy czasowe: Baseline and Week 12 (post-intervention)

Change in skeletal muscle mass, measured in kilograms (kg), will be assessed using the SECA mBCA bioelectrical impedance analysis system.
Baseline and Week 12 (post-intervention)
Change in Visceral Adipose Tissue
Ramy czasowe: Baseline and Week 12 (post-intervention)

Change in visceral adipose tissue, measured in liters, will be assessed using the SECA mBCA bioelectrical impedance analysis system.
Baseline and Week 12 (post-intervention)
Change in Handgrip Strength
Ramy czasowe: Baseline and Week 12 (post-intervention)

Handgrip strength will be assessed using a calibrated hydraulic hand dynamometer. Grip force will be recorded in kilograms (kg), with higher values indicating greater muscle strength.
Baseline and Week 12 (post-intervention)
Change in Cardiorespiratory Fitness (6-minute walk test (6MWT))
Ramy czasowe: Baseline and Week 12 (post-intervention)

Cardiorespiratory fitness is measured by the 6-Minute Walk Test (6MWT) as the total distance walked (meters) in six minutes.
Baseline and Week 12 (post-intervention)
Change in Nutritional Intake and Diet Quality
Ramy czasowe: Baseline and Week 12 (post-intervention)

Diet quality will be assessed using the Mini-EAT instrument. The Mini-EAT generates a total score ranging from 0 to 90 points, with higher scores indicating greater adherence to healthy dietary patterns and better overall diet quality.
Baseline and Week 12 (post-intervention)
Change in Depression Symptoms
Ramy czasowe: Baseline and Week 12 (post-intervention)

Depression symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items with a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Baseline and Week 12 (post-intervention)
Change in Anxiety Symptoms
Ramy czasowe: Baseline and Week 12 (post-intervention)

Anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 consists of 7 items with a total score ranging from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
Baseline and Week 12 (post-intervention)
Change in General Well-Being
Ramy czasowe: Baseline and Week 12 (post-intervention)

General well-being will be assessed using the World Health Organization-5 Well-Being Index (WHO-5). The WHO-5 consists of 5 items with a total raw score ranging from 0 to 25, with higher scores indicating better well-being.
Baseline and Week 12 (post-intervention)
Change in Composite Blood Lipid Profile
Ramy czasowe: Baseline and Week 12 (post-intervention)

A composite blood lipid score will be calculated using total cholesterol (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), and triglycerides (mg/dL) measurements obtained from blood samples collected and analyzed using standard clinical laboratory methods.
Baseline and Week 12 (post-intervention)
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Ramy czasowe: Baseline and Week 12 (post-intervention)

Change in high-sensitivity C-reactive protein (hs-CRP) levels, measured in milligrams per liter (mg/L), will be assessed from study blood draws and/or clinically obtained laboratory results when available and authorized.
Baseline and Week 12 (post-intervention)
Change in N-Terminal Pro-B-Type Natriuretic Peptide
Ramy czasowe: Baseline and Week 12 (post-intervention)

N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, measured in picograms per milliliter (pg/mL), will be assessed from study blood draws and/or clinically obtained laboratory results when available and authorized.
Baseline and Week 12 (post-intervention)
Change in Glycosylated Hemoglobin (HbA1c)
Ramy czasowe: Baseline and Week 12 (post-intervention)

Hemoglobin A1c (HbA1c), measured as a percentage (%), will be assessed using study blood draws and/or clinically obtained laboratory results when available and authorized.
Baseline and Week 12 (post-intervention)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Miami

Śledczy

  • Główny śledczy: Arlette Perry, PhD, University of Miami

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 stycznia 2027

Zakończenie podstawowe (Szacowany)

1 stycznia 2028

Ukończenie studiów (Szacowany)

1 stycznia 2028

Daty rejestracji na studia

Pierwszy przesłany

4 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 listopada 2026

Pierwszy wysłany (Rzeczywisty)

10 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20260737

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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