- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07745270
High-Intensity Functional Training (HIFT) vs Moderate-Intensity Continuous Training (MICT) in College Students
29 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Typ studiów
Interwencyjne
Zapisy (Szacowany)
90
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Arlette Perry, PhD
- Numer telefonu: 305-284-3025
- E-mail: aperry@miami.edu
Lokalizacje studiów
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-
Florida
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Coral Gables, Florida, Stany Zjednoczone, 33146
- Merrick Building, University of Miami
-
Kontakt:
- Arlette Perry, PhD
- Numer telefonu: 305-284-3025
- E-mail: aperry@miami.edu
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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Eksperymentalny: 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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Brak interwencji: Control Group
The control group will not receive supervised exercise training during the intervention period.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Carotid-Femoral Pulse Wave Velocity (cfPWV)
Ramy czasowe: 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)
|
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Change in Central Augmentation Index (cAIx)
Ramy czasowe: 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.
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Baseline and Week 10 (post-intervention)
|
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Change in Mean Arterial Pressure (MAP)
Ramy czasowe: 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)
Ramy czasowe: Baseline and Week 10 (post-intervention)
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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)
Ramy czasowe: 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.
|
Baseline and Week 10 (post-intervention)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Body mass index (BMI)
Ramy czasowe: 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)
Ramy czasowe: Baseline and 10 weeks (post-intervention)
|
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%)
Ramy czasowe: Baseline and 10 weeks (post-intervention)
|
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)
Ramy czasowe: Baseline and 10 weeks (post-intervention)
|
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)
Ramy czasowe: Baseline and 10 weeks (post-intervention)
|
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
Ramy czasowe: Baseline and Week 10 (post-intervention)
|
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
Ramy czasowe: Baseline and Week 10 (post-intervention)
|
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
Ramy czasowe: 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.
|
Baseline and Week 10 (post-intervention)
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Change in Flexibility (Sit-and-Reach test)
Ramy czasowe: 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)
Ramy czasowe: 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).
|
Baseline and Week 10 (post-intervention)
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Arlette Perry, PhD, University of Miami
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 września 2026
Zakończenie podstawowe (Szacowany)
1 czerwca 2028
Ukończenie studiów (Szacowany)
1 czerwca 2028
Daty rejestracji na studia
Pierwszy przesłany
15 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 lipca 2026
Pierwszy wysłany (Rzeczywisty)
4 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
4 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
29 lipca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 20260670
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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