Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

7 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

30

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Mild Disability Group (EDSS 0 to <=2.5)
Beteende: 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.
Experimentell: Moderate Disability Group (EDSS 3.0 to <=4.5)
Beteende: 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.
Experimentell: Severe Disability Group (EDSS 5.0 to <=6.5)
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maximum Walking Distance
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fatigue
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hacettepe University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 januari 2028

Studieregistreringsdatum

Först inskickad

4 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

14 augusti 2026

Första postat (Faktisk)

18 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Hacettepe-PT-MS-01

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera