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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Hacettepe University • ClinicalTrials.gov ID: NCT07771868

Registry updated: 2026-09-10
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Description

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.

Interventions

  • High-Intensity Interval Training (Behavioral)
    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.

Eligibility criteria

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

Conditions

MULTIPL SCLEROSİS

Locations

  • Hatay Mustafa Kemal Universty — Hatay, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record