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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHacettepe University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Mild Disability Group (EDSS 0 to <=2.5)Experimental treatment 1 intervention
Group B: Moderate Disability Group (EDSS 3.0 to <=4.5)Experimental treatment 1 intervention
Group C: Severe Disability Group (EDSS 5.0 to <=6.5)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Walking Distance

Maximum walking distance (in meters) will be objectively estimated using a predictive model previously developed by our research team.

Time frame
Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up)

Secondary outcomes

1

Fatigue

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.

Time frame
Baseline, immediately post-intervention, and 4 weeks follow-up
2

Muscle Strength

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.

Time frame
Baseline, immediately post-intervention, and 4 weeks follow-up
3

Muscular Endurance

It will be evaluated through repetitive muscle contraction tests.

Time frame
Baseline, immediately post-intervention, and 4 weeks follow-up
4

Gait Speed

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.

Time frame
Baseline, immediately post-intervention, and 4 weeks follow-up

Other outcomes

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