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

4 novembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

200

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Arlette Perry, PhD
  • Numero di telefono: 305-898-7370
  • Email: aperry@miami.edu

Luoghi di studio

  • Stati Uniti
    • Florida
      • Coral Gables, Florida, Stati Uniti, 33146
        • Merrick Building, University of Miami
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

45 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Sperimentale: 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.
Comportamentale: 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.
Nessun intervento: Control Group

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Carotid-Femoral Pulse Wave Velocity (cfPWV)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Body Mass Index (BMI)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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))
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Miami

Investigatori

  • Investigatore principale: Arlette Perry, PhD, University of Miami

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 gennaio 2027

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

4 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 novembre 2026

Primo Inserito (Effettivo)

10 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 20260737

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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