- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07578740
The Effects of High-Intensity Interval Training on Gait, Balance, and Cognitive Functions in Individuals With Multiple Sclerosis (HIIT-MS)
Investigating the Effects of High-Intensity Interval Training on Gait, Balance, and Cognition in Individuals With Multiple Sclerosis
This study aims to comparatively investigate the effects of low-volume High-Intensity Interval Training (HIIT) versus Moderate-Intensity Continuous Training (MICT) on gait, balance, cognitive functions, and neurovascular biomarkers (BDNF, VEGF) in individuals with Multiple Sclerosis (MS). This randomized controlled trial will be conducted at Hacettepe University, Faculty of Physical Therapy and Rehabilitation.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Individuals with MS aged 18 and older, with an EDSS score of 0-4, no relapse in the past three months, and medically stable condition will be randomized into two groups using a sealed-envelope method. Group 1 will receive MICT on a cycle ergometer (twice weekly, 8 weeks); Group 2 will receive low-volume HIIT with the same frequency. Both groups will receive an individualized physiotherapy program after each aerobic session. Outcomes include gait (TUG, T25FW, DGI), balance (Mini-BESTest, mCTSIB), cognitive function (BICAMS: SDMT, CVLT-II, BVMT-R), exercise capacity (ISWT), and blood biomarkers (BDNF, VEGF) assessed via ELISA.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kübra Turan, Msc, PT
- Numéro de téléphone: +90 506 516 41 58
- E-mail: kubraaturann5@gmail.com
Lieux d'étude
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Ankara, Turquie (Türkiye)
- Hacettepe University
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Contact:
- Kübra Turan
- Numéro de téléphone: +90 506 516 41 58
- E-mail: kubraaturann5@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Diagnosed with Multiple Sclerosis by a neurologist (Hacettepe University Hospitals, Neurology Outpatient Clinic)
- Age 18 years and older
- EDSS score between 0 and 4
- Score of 24 or above on the Standardized Mini Mental State Examination
- No relapse in the past 3 months
- Medically stable for at least 6 months
Exclusion Criteria:
• Any additional cardiopulmonary, neurological, or systemic disease other than MS
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: MICT Group (Moderate-Intensity Continuous Training)
Cycle ergometer-based MICT, twice weekly for 8 weeks, starting at 60% of peak workload, progressing to 80%. Sessions include 5-min warm-up, 20-30 min exercise, 5-min cool-down, followed by 30-min individualized physiotherapy. |
Cycle ergometer-based exercise, twice weekly for 8 weeks. Starting intensity at 60% of peak workload, progressing to 80%. Each session includes 5-min warm-up, 20-30 min continuous exercise, and 5-min cool-down, followed by 30-min individualized physiotherapy program. |
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Expérimental: HIIT Group (High-Intensity Interval Training)
HIIT on cycle ergometer, twice weekly for 8 weeks. Protocol: 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each, followed by 5-min cool-down. Total session: ~20 min aerobic + 30-min individualized physiotherapy. |
Cycle ergometer-based exercise, twice weekly for 8 weeks. Each session includes 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each interval, and 5-min cool-down. Total aerobic exercise duration: ~20 min, followed by 30-min individualized physiotherapy program. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Timed Up and Go Test (TUG)
Délai: Baseline and 8 weeks
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Timed Up and Go Test (TUG). Participants are asked to rise from a standard chair, walk 3 meters, turn around, walk back, and sit down as fast as safely possible. Measured in seconds. Lower values indicate better functional mobility and balance. |
Baseline and 8 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Serum BDNF levels (ELISA)
Délai: Baseline and 8 weeks
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Baseline and 8 weeks
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Serum VEGF levels (ELISA)
Délai: Baseline and 8 weeks
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Baseline and 8 weeks
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Timed 25-Foot Walk Test (T25FW)
Délai: Baseline and 8 weeks
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Timed 25-Foot Walk Test (T25FW). Participants are instructed to walk 7.62 meters (25 feet) as quickly and safely as possible. Measured in seconds. Lower values indicate better walking speed. |
Baseline and 8 weeks
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Dynamic Gait Index (DGI)
Délai: Baseline and 8 weeks
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Dynamic Gait Index (DGI). Assesses the ability to maintain balance while walking under varied conditions across 8 tasks. Minimum score: 0, Maximum score: 24. Higher scores indicate better dynamic gait balance. |
Baseline and 8 weeks
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Incremental Shuttle Walk Test (ISWT)
Délai: Baseline and 8 weeks
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Incremental Shuttle Walk Test (ISWT). Participants walk between two cones placed 9 meters apart at increasing speeds guided by audio signals until they can no longer maintain the required pace. Measured in meters walked. Higher values indicate better functional exercise capacity. |
Baseline and 8 weeks
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Mini Balance Evaluation Systems Test (Mini-BESTest)
Délai: Baseline and 8 weeks
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Mini Balance Evaluation Systems Test (Mini BESTest). Assesses dynamic balance across 14 items in 4 subsections: anticipatory postural control, reactive postural control, sensory orientation, and dynamic gait. Minimum score: 0, Maximum score: 28. Higher scores indicate better balance performance. |
Baseline and 8 weeks
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Modified CTSIB (mCTSIB) - Static Posturography
Délai: Baseline and 8 weeks
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Modified Clinical Test of Sensory Interaction and Balance (mCTSIB). Assesses static postural stability under 4 conditions: eyes open/closed on firm and foam surfaces. Postural sway is measured in degrees per second. Lower values indicate better static balance. |
Baseline and 8 weeks
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Symbol Digit Modalities Test (SDMT)
Délai: Baseline and 8 weeks
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Part of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. Assesses information processing speed in neurological conditions. Participants are asked to match symbols with corresponding digits within 90 seconds. Minimum score: 0, Maximum score: 110. Higher scores indicate better cognitive processing speed. |
Baseline and 8 weeks
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California Verbal Learning Test-II (CVLT-II)
Délai: Baseline and 8 weeks
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Part of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. Assesses auditory and verbal memory. A list of 16 words across 4 categories is read aloud and recalled over 5 trials. Minimum score: 0, Maximum score: 80. Higher scores indicate better verbal learning and memory. |
Baseline and 8 weeks
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Brief Visuospatial Memory Test-Revised (BVMT-R)
Délai: Baseline and 8 weeks
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Part of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. Assesses visuospatial memory. Six geometric figures are presented and participants are asked to reproduce them from memory. Minimum score: 0, Maximum score: 36. Higher scores indicate better visuospatial memory. |
Baseline and 8 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Yeliz SALCI, Hacettepe University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux
- Maladies auto-immunes
- Maladies du système immunitaire
- Maladies auto-immunes démyélinisantes, SNC
- Maladies auto-immunes du système nerveux
- Maladies démyélinisantes
- Sclérose en plaques
- Activité motrice
- Mouvement
- Phénomènes physiologiques musculo-squelettiques
- Phénomènes physiologiques musculo-squelettiques et neuronaux
- Conditionnement physique, humain
- Exercice
- Formation d'intervalle à haute intensité
Autres numéros d'identification d'étude
- FTREK26/19
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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