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High-Intensity Interval Training for Walking and Function Across Different Multiple Sclerosis Disability Levels

7 septembre 2026 mis à jour par: ISMAIL KARA, Hacettepe University

The Effect of High-Intensity Interval Training on Maximum Walking Distance and Functional Parameters in Patients With Multiple Sclerosis at Different Disability Levels

Multiple Sclerosis (MS) is a chronic neurological disease that can affect daily functioning, mobility, and overall quality of life. High-Intensity Interval Training (HIIT) is known to be a time-efficient exercise approach that improves exercise capacity and reduces fatigue in MS. However, current research lacks sufficient data on how HIIT affects individuals with different levels of disability.

The main purpose of this study is to evaluate the effects of a stationary bicycle-based HIIT protocol on maximum walking distance, fatigue, balance, muscle strength, endurance, gait speed, and quality of life in MS patients across three different disability levels: mild, moderate, and severe (classified according to Expanded Disability Status Scale - EDSS scores).

Participants will complete a cycle ergometer-based HIIT program. Assessments will be conducted at three time points:

Before starting the exercise program (baseline)

Immediately after completing the program (post-treatment)

4 weeks after the completion of the program (follow-up)

To ensure unbiased results, a triple-blind design will be used, meaning the outcome assessor, the treating physiotherapist, and the data analyst will be blinded to group assignments. The findings aim to help clinicians tailor personalized, effective HIIT protocols based on a patient's specific disability level rather than using a standardized, one-size-fits-all approach in MS rehabilitation.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Be between the ages of 18 and 65,
  • Have been diagnosed with MS by a treating physician,
  • Have an EDSS score between 0 and 6.5,
  • Not having experienced a relapse within the last 3 months,
  • Not having severe lower extremity contractures, severe spasticity (≥3 on the Modified Ashworth Scale), or an acute orthopedic problem that would prevent the participant from pedaling on a bicycle ergometer,
  • Having a Mini Mental State Examination score of ≥24.

Exclusion Criteria:

  • Having a severe cardiovascular, orthopedic, respiratory, or metabolic disease,
  • Having an additional neurological condition,
  • Being pregnant or suspecting pregnancy,
  • Having received a botulinum toxin injection within the last 3 months,
  • Having a COMPASS-31 total score greater than 13.6

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Mild Disability Group (EDSS 0 to <=2.5)
Comportemental: High-Intensity Interval Training
All exercise sessions in our study will be conducted using a bicycle ergometer (Monark Cardio Care 827 X, Monark Exercise AB, Sweden). The HIIT protocol will consist of five 3-minute high-intensity intervals performed at 80-100 revolutions per minute, corresponding to 85-90% of maximum heart rate. Between these intervals, active rest periods will be implemented, during which cadence is reduced to 50-60 revolutions per minute for 1.5 minutes to lower heart rate to 50-60% of maximum heart rate. The total training duration is planned to be 20 minutes, consisting of a 2-minute warm-up at the beginning and a 2-minute cool-down at the end. Sessions will be conducted three times a week. The total treatment duration is planned to be 8 weeks.
Expérimental: Moderate Disability Group (EDSS 3.0 to <=4.5)
Comportemental: High-Intensity Interval Training
All exercise sessions in our study will be conducted using a bicycle ergometer (Monark Cardio Care 827 X, Monark Exercise AB, Sweden). The HIIT protocol will consist of five 3-minute high-intensity intervals performed at 80-100 revolutions per minute, corresponding to 85-90% of maximum heart rate. Between these intervals, active rest periods will be implemented, during which cadence is reduced to 50-60 revolutions per minute for 1.5 minutes to lower heart rate to 50-60% of maximum heart rate. The total training duration is planned to be 20 minutes, consisting of a 2-minute warm-up at the beginning and a 2-minute cool-down at the end. Sessions will be conducted three times a week. The total treatment duration is planned to be 8 weeks.
Expérimental: Severe Disability Group (EDSS 5.0 to <=6.5)
Comportemental: High-Intensity Interval Training
All exercise sessions in our study will be conducted using a bicycle ergometer (Monark Cardio Care 827 X, Monark Exercise AB, Sweden). The HIIT protocol will consist of five 3-minute high-intensity intervals performed at 80-100 revolutions per minute, corresponding to 85-90% of maximum heart rate. Between these intervals, active rest periods will be implemented, during which cadence is reduced to 50-60 revolutions per minute for 1.5 minutes to lower heart rate to 50-60% of maximum heart rate. The total training duration is planned to be 20 minutes, consisting of a 2-minute warm-up at the beginning and a 2-minute cool-down at the end. Sessions will be conducted three times a week. The total treatment duration is planned to be 8 weeks.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Maximum Walking Distance
Délai: Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up)
Maximum walking distance (in meters) will be objectively estimated using a predictive model previously developed by our research team.
Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Fatigue
Délai: Baseline, immediately post-intervention, and 4 weeks follow-up
Fatigue will be evaluated with the Fatigue Severity Scale. This scale also assesses the fatigue severity of patients through 9 questions. Each question has a score ranging from 1 (strongly disagree) to 7 (strongly agree). The fatigue severity scale score is determined by calculating the average value of the responses given to these 9 questions. A higher score indicates greater fatigue severity.
Baseline, immediately post-intervention, and 4 weeks follow-up
Muscle Strength
Délai: Baseline, immediately post-intervention, and 4 weeks follow-up
It will be evaluated using a hand-held dynamometer. In this test, which will be performed in a long-sitting position with the hips in 90 degrees of flexion and the knees in extension, the measuring device (Lafayette Instrument Company, Lafayette IN, USA) will be placed on the sole of the foot. The patient will then be asked to press their foot downward, and the result will be recorded.
Baseline, immediately post-intervention, and 4 weeks follow-up
Muscular Endurance
Délai: Baseline, immediately post-intervention, and 4 weeks follow-up
It will be evaluated through repetitive muscle contraction tests.
Baseline, immediately post-intervention, and 4 weeks follow-up
Gait Speed
Délai: Baseline, immediately post-intervention, and 4 weeks follow-up
The walking speeds of the participants will be evaluated using the 10-Meter Walk Test, whose validity and reliability have been proven in clinical studies. During the assessment, participants will be asked to walk along a 10-meter straight and obstacle-free corridor at their normal pace, and the elapsed time will be recorded using a stopwatch.
Baseline, immediately post-intervention, and 4 weeks follow-up
Health-Related Quality of Life
Délai: Baseline, immediately post-intervention, and 4 weeks follow-up
It will be evaluated using the Multiple Sclerosis Impact Scale-29. The questionnaire assesses the impact of MS on daily life over the past two weeks. Responses are recorded on a 5-point Likert scale ranging from 1 ("not at all") to 5 ("extremely").
Baseline, immediately post-intervention, and 4 weeks follow-up
balance
Délai: Baseline, immediately post-intervention, and 4 weeks follow-up
Objective balance assessments of the participants will be performed using the TecnoBody PK200 Balance Device. As part of the assessment protocol, patients will sequentially undergo stabilometric static balance, the Romberg test in eyes-open and eyes-closed positions, single-leg stance on the right and left, and dynamic balance tests.
Baseline, immediately post-intervention, and 4 weeks follow-up
Dynamic Balance
Délai: Baseline, immediately post-intervention, and 4 weeks follow-up
It will be evaluated using the Community Balance and Mobility Scale. This scale evaluates balance and mobility status across 13 tasks that involve advanced functional balance and mobility activities. Each item is scored between 0 and 5 (0 = unable to perform, 5 = able to perform independently). Item 12 is scored from 0 to 6, with an additional point added if a basket is carried while descending the stairs. Higher scores indicate better balance and mobility.
Baseline, immediately post-intervention, and 4 weeks follow-up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hacettepe University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2026

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 janvier 2028

Dates d'inscription aux études

Première soumission

4 août 2026

Première soumission répondant aux critères de contrôle qualité

14 août 2026

Première publication (Réel)

18 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Hacettepe-PT-MS-01

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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