An interventional study of High-Intensity Functional Training (HIFT) and Moderate-Intensity Continuous Training (MICT) in Cardiovascular Disease (CVD), sponsored by University of Miami. Not yet recruiting at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of cardiovascular disease (CVD): Clinically documented by a licensed clinician in the medical record, including at least one of the following:
Exclusion Criteria:
Hemodynamic instability or severe uncontrolled disease:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: High-Intensity Functional Training (HIFT)
Participants assigned to the MICT group will perform supervised moderate-intensity continuous aerobic exercise three days per week for a total of 12 weeks.
Behavioral: Moderate-Intensity Continuous Training (MICT)
Participants in this group will be asked to maintain their usual diet, usual medical care, physical activity, and lifestyle behaviors.
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.
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.
Change in Carotid-Femoral Pulse Wave Velocity (cfPWV)
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in Central Augmentation Index (cAIx)
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in Mean Arterial Pressure (MAP)
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.
Time frame: Baseline and Week 12 (post-intervention)
Percent Change in Flow-Mediated Dilation (FMD)
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in Carotid Intima-Media Thickness (cIMT)
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in Body Mass Index (BMI)
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in Waist Circumference
Change in waist circumference, measured in centimeters (cm), will be assessed using a standardized measuring tape.
Time frame: Baseline and Week 12 (post-intervention)
Change in Body Fat Percentage
Change in body fat percentage, measured as a percentage (%), will be assessed using the SECA mBCA bioelectrical impedance analysis system.
Time frame: Baseline and Week 12 (post-intervention)
Change in Skeletal Muscle Mass
Change in skeletal muscle mass, measured in kilograms (kg), will be assessed using the SECA mBCA bioelectrical impedance analysis system.
Time frame: Baseline and Week 12 (post-intervention)
Change in Visceral Adipose Tissue
Change in visceral adipose tissue, measured in liters, will be assessed using the SECA mBCA bioelectrical impedance analysis system.
Time frame: Baseline and Week 12 (post-intervention)
Change in Handgrip Strength
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in Cardiorespiratory Fitness (6-minute walk test (6MWT))
Cardiorespiratory fitness is measured by the 6-Minute Walk Test (6MWT) as the total distance walked (meters) in six minutes.
Time frame: Baseline and Week 12 (post-intervention)
Change in Nutritional Intake and Diet Quality
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in Depression Symptoms
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in Anxiety Symptoms
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in General Well-Being
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in Composite Blood Lipid Profile
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in N-Terminal Pro-B-Type Natriuretic Peptide
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.
Time frame: Baseline and Week 12 (post-intervention)
Change in Glycosylated Hemoglobin (HbA1c)
Hemoglobin A1c (HbA1c), measured as a percentage (%), will be assessed using study blood draws and/or clinically obtained laboratory results when available and authorized.
Time frame: Baseline and Week 12 (post-intervention)
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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