- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07719296
HIIT, Cardiorespiratory Fitness, and Metabolic Health in Healthy Young Adults
17 luglio 2026 aggiornato da: Nejmeddine Ouerghi, High Institute of Sports and Physical Education of Kef
High-intensity Interval Training Improves Cardiorespiratory Fitness and Modestly Enhances Metabolic Health in Healthy Young Adults : a Randomized Controlled Trial
The purpose of this study was to investigate the effects of a high-intensity interval training (HIIT) intervention on cardiorespiratory fitness (CRF) and cardiometabolic health in active male university students.
The main question it aims to answer is: Does HIIT improves CRF and cardiometabolic outcomes, including blood pressure, lipid profile, and insulin resistance estimated using the homeostasis model assessment of insulin resistance (HOMA-IR).
Researchers will compare HIIT (designed to experimental group) to non-training intervention (designed to control group) to see if the training program works to improve the cardiometabolic health status.
The HIIT program consisted of three sessions per week for 9 weeks, comprising of three sets of six to eight 30-second running bouts performed at 100-110% of maximal aerobic speed (MAS), interspersed with 30-second active recovery runs at 50% MAS between bouts.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
High-intensity interval training (HIIT) is a time-efficient exercise strategy for improving physical fitness.
However, limited evidence is available regarding its effects on cardiometabolic health, including blood pressure, blood lipid profile, glucose metabolism, and insulin resistance, in healthy young adults.
The purpose of this randomized controlled trial was to investigate the effects of a 9-week HIIT intervention on cardiorespiratory fitness (CRF), blood pressure, blood lipid profile, glucose, insulin, and insulin resistance estimated using the homeostasis model assessment of insulin resistance (HOMA-IR) in physically active male university students.
Twenty-nine healthy male students at the High Institute of Sport and Physical Education of Kef (Tunisia) were randomly assigned to either the HIIT group (HIITG, n=15) or the control group (CG, n=14).
The HIIT group completed a supervised training program consisting of three sessions per week for 9 weeks, comprising of three sets of six to eight 30-second running bouts performed at 100-110% of maximal aerobic speed (MAS), interspersed with 30-second active recovery runs at 50% MAS between bouts.
Outcome assessments were performed before and after the intervention.
Cardiorespiratory fitness was evaluated by maximal oxygen consumption (VO₂max) and maximal aerobic speed (MAS) using the Vameval incremental running test.
Cardiometabolic outcomes included systolic and diastolic blood pressure, total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), fasting glucose, fasting insulin, and insulin resistance estimated using the homeostasis model assessment of insulin resistance (HOMA-IR).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
29
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.
Luoghi di studio
-
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Boulifa
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El Kef, Boulifa, Tunisia, 7100
- Tunisia
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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:
- Male university students at the High Institute of Sport and Physical Education, Kef, Tunisia.
- Aged 19 to 25 years
- Provided written informed consent
Exclusion Criteria:
- Acute or chronic disease contraindicating vigorous physical exercise
- Musculoskeletal injury or any other medical condition limiting participation in exercise
- Participation in another structured training program within the previous 6 months
- Current or recent (within the previous 3 months) use of medications or dietary supplements that could influence the study outcomes
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: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Gruppo di controllo
I partecipanti nel gruppo di controllo hanno mantenuto le loro normali attività quotidiane.
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Sperimentale: High-intensity interval training (HIIT) group
The HIIT group performed a HIIT program consisting of three sessions per week for 9 weeks, including three sets of six to eight bouts of 30-second runs at high intensity [100-110% of maximal aerobic speed (MAS)], interspersed with 30-second recovery runs at low intensity (50% MAS) between bouts, in line with recommendations by Ouerghi et al. (2017, 2026) in young males.
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The HIIT program consisted of three sessions per week for 9 weeks, comprising of three sets of sixr to eight bouts of 30-second runs at high intensity [100-110% of maximal aerobic speed (MAS)], interspersed with 30-second recovery runs at low intensity (50% MAS) between bouts.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Insulin resistance
Lasso di tempo: One day before the start and two days after the completion of the 09 weeks of training program.
|
Insulin resistance was estimated by the homeostasis model assessment (HOMA-IR) index as HOMA-IR = (fasting insulin (mU/l) × fasting glucose (mmol/l) / 22.5)) (Matthews et al., 1985).
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One day before the start and two days after the completion of the 09 weeks of training program.
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Total cholesterol
Lasso di tempo: One day before the start and two days after the completion of the 09 weeks of training program.
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Total cholesterol concentration, expressed in mg/dL, was assessed by the enzymatic method on an Architect C8000 auto analyzer (Abbott Laboratories, Abbott Park, IL) using respective reagent kits.
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One day before the start and two days after the completion of the 09 weeks of training program.
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Triglyceride
Lasso di tempo: One day before the start and two days after the completion of the 09 weeks of training program.
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Triglyceride concentration, expressed in mg/dL, was assessed by the enzymatic method on an Architect C8000 auto analyzer (Abbott Laboratories, Abbott Park, IL) using respective reagent kits.
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One day before the start and two days after the completion of the 09 weeks of training program.
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Blood pressure
Lasso di tempo: One day before the start and two days after the completion of the 09 weeks of training program
|
Blood pressure, expressed in mmHg, was measured after 15 minutes of seated rest using an automatic blood pressure monitor (Omron BP652; Omron Healthcare Inc., Vernon Hills, IL, USA).
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One day before the start and two days after the completion of the 09 weeks of training program
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Body mass index
Lasso di tempo: One day before the start and two days after the completion of the 09 weeks of training program
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Body mass index (BMI), expressed in kg/m², was calculated using the following formula: BMI = body mass (kg) / height² (m²).
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One day before the start and two days after the completion of the 09 weeks of training program
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Cardiorespiratory fitness
Lasso di tempo: One day before the start and two days after the completion of the 09 weeks of training program.
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Cardiorespiratory fitness was assessed using the Vameval incremental running test performed to exhaustion (Cazorla, 1999).
Maximal aerobic speed (MAS) was determined from the highest running speed achieved during the test, and maximal oxygen consumption (VO2max) was estimated using the standard Vameval protocol (Cazorla, 1999).
The Vameval test is a validated field test for assessing aerobic capacity in healthy young adults.
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One day before the start and two days after the completion of the 09 weeks of training program.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Fasting glucose
Lasso di tempo: One day before the start and two days after the completion of the 09 weeks of training program.
|
Fasting glucose concentration, expressed in mg/dL, was assessed by the enzymatic method on an Architect C8000 auto analyzer (Abbott Laboratories, Abbott Park, IL) using respective reagent kits.
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One day before the start and two days after the completion of the 09 weeks of training program.
|
|
Insulin
Lasso di tempo: One day before the start and two days after the completion of the 09 weeks of training program.
|
Insulin concentration, expressed in µU/mL, was measured by chemiluminescence immunoassay using a Liaison analyzer and the respective reagents kit (DiaSorin Inc., Stillwater, MN, USA).
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One day before the start and two days after the completion of the 09 weeks of training program.
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High-density lipoprotein cholesterol
Lasso di tempo: One day before the start and two days after the completion of the 09 weeks of training program.
|
High-density lipoprotein cholesterol, expressed in mg/dL, was assessed by the enzymatic method on an Architect C8000 auto analyzer (Abbott Laboratories, Abbott Park, IL) using respective reagent kits.
|
One day before the start and two days after the completion of the 09 weeks of training program.
|
|
Low-density lipoprotein cholesterol
Lasso di tempo: One day before the start and two days after the completion of the 09 weeks of training program
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Low-density lipoprotein cholesterol, expressed in mg/dL, was calculated using the Friedewald formula (Friedewald et al., 1972).
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One day before the start and two days after the completion of the 09 weeks of training program
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Nejmeddine Ouerghi, Ph.D, Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
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 (Effettivo)
1 dicembre 2025
Completamento primario (Effettivo)
16 febbraio 2026
Completamento dello studio (Effettivo)
16 febbraio 2026
Date di iscrizione allo studio
Primo inviato
17 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
17 luglio 2026
Primo Inserito (Effettivo)
22 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie metaboliche
- Disturbi del metabolismo del glucosio
- Iperinsulinismo
- Malattie nutrizionali e metaboliche
- Resistenza all'insulina
- Attività motoria
- Movimento
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Condizionamento fisico, umano
- Esercizio
- Allenamento a intervalli ad alta intensità
Altri numeri di identificazione dello studio
- HIIT-MET-STUDENTS
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 .
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