NCT07745270

Brief Summary

The purpose of this study is to compare two types of exercise programs in college students: high-intensity functional training and moderate-intensity continuous training. The study evaluates whether these exercise programs improve body composition, physical fitness, and blood vessel health compared with a group that does not participate in exercise training. In addition, the study examines whether changes in body composition and physical fitness are associated with changes in blood vessel health.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

August 4, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

July 15, 2026

Last Update Submit

July 29, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in Carotid-Femoral Pulse Wave Velocity (cfPWV)

    Carotid-femoral pulse wave velocity (cfPWV) will be measured in meters per second (m/s) at baseline and post intervention 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 10 (post-intervention)

  • Change in Central Augmentation Index (cAIx)

    The central augmentation index (cAIx), expressed as a percentage, will be assessed at baseline and post-intervention 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 10 (post-intervention)

  • Change in Mean Arterial Pressure (MAP)

    Mean arterial pressure (MAP), measured in millimeters of mercury (mmHg), will be assessed at baseline and post-intervention. MAP will be assessed using the SphygmoCor XCEL system (AtCor Medical) based on an algorithm derived from peripheral blood pressure obtained via an automated upper arm cuff.

    Baseline and Week 10 (post-intervention)

  • Percent Change in Flow-Mediated Dilation (FMD)

    Flow-Mediated Dilation (FMD) will be measured at baseline and post-intervention using a Philips Affiniti 50 ultrasound system and expressed as the percent (%) change in brachial artery diameter from pre-occlusion baseline to peak dilation following a 5-minute forearm occlusion. The outcome will be reported as the change in FMD (%) from baseline to post-intervention.

    Baseline and Week 10 (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 at baseline and post-intervention. 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 10 (post-intervention)

Secondary Outcomes (10)

  • Change in Body mass index (BMI)

    Baseline and Week 10 (post-intervention)

  • Change in Waist Circumference (WC)

    Baseline and 10 weeks (post-intervention)

  • Change in Body fat percentage (BF%)

    Baseline and 10 weeks (post-intervention)

  • Change in Skeletal Muscle Mass (SMM)

    Baseline and 10 weeks (post-intervention)

  • Change in visceral adipose tissue (VAT)

    Baseline and 10 weeks (post-intervention)

  • +5 more secondary outcomes

Study Arms (3)

High-intensity Functional Training (HIFT) Group

EXPERIMENTAL

Participants in this group will perform supervised high-intensity functional training (HIFT) using multi-joint functional movements. Participants will complete training 3 days per week for 8 weeks.

Behavioral: High-Intensity Functional Training (HIFT)

Moderate-intensity Continuous Training (MICT) Group

EXPERIMENTAL

Participants in this group will perform supervised moderate-intensity continuous aerobic exercise. Participants will complete training 3 days per week for 8 weeks.

Behavioral: Moderate-Intensity Continuous Training (MICT)

Control Group

NO INTERVENTION

The control group will not receive supervised exercise training during the intervention period.

Interventions

Participants will perform supervised high-intensity functional training using multi-joint functional movements that may include body-weight exercises, resistance-based movements, step-ups, squats, lunges, push-ups or modified push-ups, core exercises, etc. The intervention will be conducted over 8 weeks, with participants completing three sessions per week. Each session will last approximately 40 to 60 minutes.

High-intensity Functional Training (HIFT) Group

Participants will perform supervised moderate-intensity continuous aerobic exercise such as treadmill walking/jogging, cycling, elliptical exercise, or step-based aerobic activity. The intervention will be conducted over 8 weeks, with participants completing three sessions per week. Each session will last approximately 40 to 60 minutes.

Moderate-intensity Continuous Training (MICT) Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 35 years.
  • Currently enrolled college or university student.
  • Able to provide written informed consent.
  • Able to attend baseline and post-intervention testing visits and participate in assigned intervention sessions.
  • Cleared for exercise participation based on the health screening form and investigator review.

You may not qualify if:

  • Known cardiovascular, metabolic, pulmonary, renal, neurological, musculoskeletal, or endocrine disorder that would make exercise unsafe or confound outcome measures.
  • Current pregnancy or planning pregnancy during the study period.
  • Current smoking, vaping nicotine products, or use of tobacco products.
  • Uncontrolled hypertension or resting blood pressure values that make exercise testing unsafe based on investigator judgment.
  • Use of medications known to substantially affect cardiovascular function, vascular tone, or exercise responses, unless approved by the PI.
  • Any injury, orthopedic limitation, or medical condition preventing safe participation in HIFT, MICT, or physical fitness testing.
  • Currently participating in structured high-intensity interval, functional, or endurance training more than two days per week during the previous three months.
  • Do not speak English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merrick Building, University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Arlette Perry, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arlette Perry, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 15, 2026

First Posted

August 4, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

August 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations