- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07745270
High-Intensity Functional Training (HIFT) vs Moderate-Intensity Continuous Training (MICT) in College Students
29 luglio 2026 aggiornato da: Arlette Perry, University of Miami
The Effects of Interval Compared to Continuous Training on Physical Variables and Vascular Health in College Students: A Three-Arm Randomized Controlled Trial
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Tipo di studio
Interventistico
Iscrizione (Stimato)
90
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: 305-284-3025
- Email: aperry@miami.edu
Luoghi di studio
-
-
Florida
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Coral Gables, Florida, Stati Uniti, 33146
- Merrick Building, University of Miami
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Contatto:
- Arlette Perry, PhD
- Numero di telefono: 305-284-3025
- Email: aperry@miami.edu
-
-
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
- Adulto
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: High-intensity Functional Training (HIFT) Group
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.
|
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.
|
|
Sperimentale: Moderate-intensity Continuous Training (MICT) Group
Participants in this group will perform supervised moderate-intensity continuous aerobic exercise.
Participants will complete training 3 days per week for 8 weeks.
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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.
|
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Nessun intervento: Control Group
The control group will not receive supervised exercise training during the intervention period.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Carotid-Femoral Pulse Wave Velocity (cfPWV)
Lasso di tempo: Baseline and Week 10 (post-intervention)
|
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)
Lasso di tempo: Baseline and Week 10 (post-intervention)
|
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)
|
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Change in Mean Arterial Pressure (MAP)
Lasso di tempo: Baseline and Week 10 (post-intervention)
|
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.
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Baseline and Week 10 (post-intervention)
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Percent Change in Flow-Mediated Dilation (FMD)
Lasso di tempo: Baseline and Week 10 (post-intervention)
|
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.
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Baseline and Week 10 (post-intervention)
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Change in Carotid Intima-Media Thickness (cIMT)
Lasso di tempo: Baseline and Week 10 (post-intervention)
|
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.
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Baseline and Week 10 (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 10 (post-intervention)
|
Body mass index (BMI), measured in kilograms per meter squared (kg/m²), will be calculated from standardized measurements of height and weight.
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Baseline and Week 10 (post-intervention)
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Change in Waist Circumference (WC)
Lasso di tempo: Baseline and 10 weeks (post-intervention)
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Waist circumference (WC), measured in centimeters (cm), will be assessed using a standardized measuring tape at the level of the iliac crest.
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Baseline and 10 weeks (post-intervention)
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Change in Body fat percentage (BF%)
Lasso di tempo: Baseline and 10 weeks (post-intervention)
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Body fat percentage (BF%) will be assessed using the SECA mBCA (Medical Body Composition Analyzer) bioelectrical impedance analyzer and reported as a percentage (%).
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Baseline and 10 weeks (post-intervention)
|
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Change in Skeletal Muscle Mass (SMM)
Lasso di tempo: Baseline and 10 weeks (post-intervention)
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Skeletal muscle mass (SMM) will be assessed using the SECA mBCA (Medical Body Composition Analyzer) bioelectrical impedance analyzer and reported in kilograms (kg).
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Baseline and 10 weeks (post-intervention)
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Change in visceral adipose tissue (VAT)
Lasso di tempo: Baseline and 10 weeks (post-intervention)
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Visceral adipose tissue (VAT) will be measured using the SECA mBCA (Medical Body Composition Analyzer) bioelectrical impedance analyzer and reported in liters (L).
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Baseline and 10 weeks (post-intervention)
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Change in Muscular Strength
Lasso di tempo: Baseline and Week 10 (post-intervention)
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Muscular strength will be measured to include lower body muscular strength and upper body handgrip strength.
Lower body muscular strength will be assessed using a hip-hinge/deadlift-style test with a force plate transducer to measure maximal force production.
Upper body handgrip strength will be assessed using a calibrated hydraulic hand dynamometer.
Results will be reported in kilograms (kg).
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Baseline and Week 10 (post-intervention)
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Change in Cardiorespiratory Fitness
Lasso di tempo: Baseline and Week 10 (post-intervention)
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Cardiorespiratory fitness will be assessed using the Queens College Step Test.
Heart rate will be recorded at the end of the test and used to measure cardiorespiratory fitness in milliliters of oxygen consumed per kilogram of body weight per minute (mL / kg / min).
The outcome will be reported as the change from baseline to post-intervention.
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Baseline and Week 10 (post-intervention)
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Change in Muscular Endurance
Lasso di tempo: Baseline and Week 10 (post-intervention)
|
Muscular endurance will be assessed using the 1-minute curl-up test.
Participants will complete as many correctly performed curl-ups as possible within 1 minute, and the number of valid repetitions will be recorded.
The outcome will be reported as the change from baseline to post-intervention.
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Baseline and Week 10 (post-intervention)
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Change in Flexibility (Sit-and-Reach test)
Lasso di tempo: Baseline and Week 10 (post-intervention)
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Flexibility will be assessed using the Sit-and-Reach test.
Participants will reach forward while seated with legs extended, and the maximum distance reached beyond the toes will be recorded in centimeters (cm).
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Baseline and Week 10 (post-intervention)
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Change in Flexibility (Trunk Lift test)
Lasso di tempo: Baseline and Week 10 (post-intervention)
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Flexibility will be assessed using the Trunk Lift Test.
Participants will lie prone and lift their upper body off the floor while maintaining a neutral head position.
The vertical distance from the floor to the participant's chin will be measured in centimeters (cm).
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Baseline and Week 10 (post-intervention)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 settembre 2026
Completamento primario (Stimato)
1 giugno 2028
Completamento dello studio (Stimato)
1 giugno 2028
Date di iscrizione allo studio
Primo inviato
15 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
29 luglio 2026
Primo Inserito (Effettivo)
4 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 luglio 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 20260670
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 .