High-Intensity Interval Training for Walking and Function Across Different Multiple Sclerosis Disability Levels
2026年9月7日 更新者：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.
研究概览
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：İSMAİL KARA, MSc
- 电话号码：+90 553 525 8700
- 邮箱：ismailkaraa46@gmail.com
学习地点
-
-
-
Hatay、土耳其（türkiye）
- 招聘中
- Hatay Mustafa Kemal Universty
-
接触：
- Yasemin Karaaslan, Phd
- 邮箱：ptyasemindeveci@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Mild Disability Group (EDSS 0 to <=2.5)
|
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.
|
|
实验性的：Moderate Disability Group (EDSS 3.0 to <=4.5)
|
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.
|
|
实验性的：Severe Disability Group (EDSS 5.0 to <=6.5)
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Maximum Walking Distance
大体时间：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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fatigue
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年9月1日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年1月31日
研究注册日期
首次提交
2026年8月4日
首先提交符合 QC 标准的
2026年8月14日
首次发布 (实际的)
2026年8月18日
研究记录更新
最后更新发布 (实际的)
2026年9月10日
上次提交的符合 QC 标准的更新
2026年9月7日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.