High-Intensity Interval Training for Walking and Function Across Different Multiple Sclerosis Disability Levels
2026년 9월 7일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: İSMAİL KARA, MSc
- 전화번호: +90 553 525 8700
- 이메일: ismailkaraa46@gmail.com
연구 장소
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Hatay, 터키 (Türkiye)
- 모병
- Hatay Mustafa Kemal Universty
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연락하다:
- Yasemin Karaaslan, Phd
- 이메일: ptyasemindeveci@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Mild Disability Group (EDSS 0 to <=2.5)
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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.
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실험적: Moderate Disability Group (EDSS 3.0 to <=4.5)
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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.
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실험적: Severe Disability Group (EDSS 5.0 to <=6.5)
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximum Walking Distance
기간: Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up)
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Maximum walking distance (in meters) will be objectively estimated using a predictive model previously developed by our research team.
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Assessed at baseline (pre-intervention), immediately post-intervention (at 8 weeks), and 4 weeks post-intervention (follow-up)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fatigue
기간: Baseline, immediately post-intervention, and 4 weeks follow-up
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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.
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Baseline, immediately post-intervention, and 4 weeks follow-up
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Muscle Strength
기간: Baseline, immediately post-intervention, and 4 weeks follow-up
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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.
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Baseline, immediately post-intervention, and 4 weeks follow-up
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Muscular Endurance
기간: Baseline, immediately post-intervention, and 4 weeks follow-up
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It will be evaluated through repetitive muscle contraction tests.
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Baseline, immediately post-intervention, and 4 weeks follow-up
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Gait Speed
기간: Baseline, immediately post-intervention, and 4 weeks follow-up
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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.
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Baseline, immediately post-intervention, and 4 weeks follow-up
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Health-Related Quality of Life
기간: Baseline, immediately post-intervention, and 4 weeks follow-up
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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").
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Baseline, immediately post-intervention, and 4 weeks follow-up
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balance
기간: Baseline, immediately post-intervention, and 4 weeks follow-up
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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.
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Baseline, immediately post-intervention, and 4 weeks follow-up
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Dynamic Balance
기간: Baseline, immediately post-intervention, and 4 weeks follow-up
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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.
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Baseline, immediately post-intervention, and 4 weeks follow-up
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 9월 1일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2028년 1월 31일
연구 등록 날짜
최초 제출
2026년 8월 4일
QC 기준을 충족하는 최초 제출
2026년 8월 14일
처음 게시됨 (실제)
2026년 8월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 7일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Hacettepe-PT-MS-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
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