Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

7 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Mild Disability Group (EDSS 0 to <=2.5)
Gedragsmatig: 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.
Experimenteel: Moderate Disability Group (EDSS 3.0 to <=4.5)
Gedragsmatig: 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.
Experimenteel: Severe Disability Group (EDSS 5.0 to <=6.5)
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximum Walking Distance
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fatigue
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hacettepe University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 september 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 januari 2028

Studieregistratiedata

Eerst ingediend

4 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 augustus 2026

Eerst geplaatst (Werkelijk)

18 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 september 2026

Laatste update ingediend die voldeed aan QC-criteria

7 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Hacettepe-PT-MS-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren