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

4. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Florida
      • Coral Gables, Florida, Forente stater, 33146
        • Merrick Building, University of Miami
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

45 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Eksperimentell: 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.
Atferdsmessig: 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.
Ingen inngripen: Control Group

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Carotid-Femoral Pulse Wave Velocity (cfPWV)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Body Mass Index (BMI)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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))
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Miami

Etterforskere

  • Hovedetterforsker: Arlette Perry, PhD, University of Miami

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

1. januar 2028

Studiet fullført (Antatt)

1. januar 2028

Datoer for studieregistrering

Først innsendt

4. november 2026

Først innsendt som oppfylte QC-kriteriene

4. november 2026

Først lagt ut (Faktiske)

10. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20260737

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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