The Effects of High-Intensity Interval Training on Gait, Balance, and Cognitive Functions in Individuals With Multiple Sclerosis (HIIT-MS)
2026年5月18日 更新者:Kübra Turan、Hacettepe University
Investigating the Effects of High-Intensity Interval Training on Gait, Balance, and Cognition in Individuals With Multiple Sclerosis
This study aims to comparatively investigate the effects of low-volume High-Intensity Interval Training (HIIT) versus Moderate-Intensity Continuous Training (MICT) on gait, balance, cognitive functions, and neurovascular biomarkers (BDNF, VEGF) in individuals with Multiple Sclerosis (MS).
This randomized controlled trial will be conducted at Hacettepe University, Faculty of Physical Therapy and Rehabilitation.
研究概览
地位
尚未招聘
详细说明
Individuals with MS aged 18 and older, with an EDSS score of 0-4, no relapse in the past three months, and medically stable condition will be randomized into two groups using a sealed-envelope method.
Group 1 will receive MICT on a cycle ergometer (twice weekly, 8 weeks); Group 2 will receive low-volume HIIT with the same frequency.
Both groups will receive an individualized physiotherapy program after each aerobic session.
Outcomes include gait (TUG, T25FW, DGI), balance (Mini-BESTest, mCTSIB), cognitive function (BICAMS: SDMT, CVLT-II, BVMT-R), exercise capacity (ISWT), and blood biomarkers (BDNF, VEGF) assessed via ELISA.
研究类型
介入性
注册 (估计的)
40
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:Kübra Turan, Msc, PT
- 电话号码:+90 506 516 41 58
- 邮箱:kubraaturann5@gmail.com
学习地点
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-
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Ankara、土耳其(türkiye)
- Hacettepe University
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接触:
- Kübra Turan
- 电话号码:+90 506 516 41 58
- 邮箱:kubraaturann5@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:
- Diagnosed with Multiple Sclerosis by a neurologist (Hacettepe University Hospitals, Neurology Outpatient Clinic)
- Age 18 years and older
- EDSS score between 0 and 4
- Score of 24 or above on the Standardized Mini Mental State Examination
- No relapse in the past 3 months
- Medically stable for at least 6 months
Exclusion Criteria:
• Any additional cardiopulmonary, neurological, or systemic disease other than MS
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:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:MICT Group (Moderate-Intensity Continuous Training)
Cycle ergometer-based MICT, twice weekly for 8 weeks, starting at 60% of peak workload, progressing to 80%.
Sessions include 5-min warm-up, 20-30 min exercise, 5-min cool-down, followed by 30-min individualized physiotherapy.
|
Cycle ergometer-based exercise, twice weekly for 8 weeks.
Starting intensity at 60% of peak workload, progressing to 80%.
Each session includes 5-min warm-up, 20-30 min continuous exercise, and 5-min cool-down, followed by 30-min individualized physiotherapy program.
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实验性的:HIIT Group (High-Intensity Interval Training)
HIIT on cycle ergometer, twice weekly for 8 weeks.
Protocol: 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each, followed by 5-min cool-down.
Total session: ~20 min aerobic + 30-min individualized physiotherapy.
|
Cycle ergometer-based exercise, twice weekly for 8 weeks.
Each session includes 5-min warm-up (40% peak workload), 10 × 1-min intervals at 90% peak workload with 1-min active recovery (60% peak workload) between each interval, and 5-min cool-down.
Total aerobic exercise duration: ~20 min, followed by 30-min individualized physiotherapy program.
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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 |
|---|---|---|
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Timed Up and Go Test (TUG)
大体时间:Baseline and 8 weeks
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Timed Up and Go Test (TUG).
Participants are asked to rise from a standard chair, walk 3 meters, turn around, walk back, and sit down as fast as safely possible.
Measured in seconds.
Lower values indicate better functional mobility and balance.
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Baseline and 8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serum BDNF levels (ELISA)
大体时间:Baseline and 8 weeks
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Baseline and 8 weeks
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Serum VEGF levels (ELISA)
大体时间:Baseline and 8 weeks
|
Baseline and 8 weeks
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Timed 25-Foot Walk Test (T25FW)
大体时间:Baseline and 8 weeks
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Timed 25-Foot Walk Test (T25FW).
Participants are instructed to walk 7.62 meters (25 feet) as quickly and safely as possible.
Measured in seconds.
Lower values indicate better walking speed.
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Baseline and 8 weeks
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Dynamic Gait Index (DGI)
大体时间:Baseline and 8 weeks
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Dynamic Gait Index (DGI).
Assesses the ability to maintain balance while walking under varied conditions across 8 tasks.
Minimum score: 0, Maximum score: 24.
Higher scores indicate better dynamic gait balance.
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Baseline and 8 weeks
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Incremental Shuttle Walk Test (ISWT)
大体时间:Baseline and 8 weeks
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Incremental Shuttle Walk Test (ISWT).
Participants walk between two cones placed 9 meters apart at increasing speeds guided by audio signals until they can no longer maintain the required pace.
Measured in meters walked.
Higher values indicate better functional exercise capacity.
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Baseline and 8 weeks
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Mini Balance Evaluation Systems Test (Mini-BESTest)
大体时间:Baseline and 8 weeks
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Mini Balance Evaluation Systems Test (Mini BESTest).
Assesses dynamic balance across 14 items in 4 subsections: anticipatory postural control, reactive postural control, sensory orientation, and dynamic gait.
Minimum score: 0, Maximum score: 28.
Higher scores indicate better balance performance.
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Baseline and 8 weeks
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Modified CTSIB (mCTSIB) - Static Posturography
大体时间:Baseline and 8 weeks
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Modified Clinical Test of Sensory Interaction and Balance (mCTSIB).
Assesses static postural stability under 4 conditions: eyes open/closed on firm and foam surfaces.
Postural sway is measured in degrees per second.
Lower values indicate better static balance.
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Baseline and 8 weeks
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Symbol Digit Modalities Test (SDMT)
大体时间:Baseline and 8 weeks
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Part of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery.
Assesses information processing speed in neurological conditions.
Participants are asked to match symbols with corresponding digits within 90 seconds.
Minimum score: 0, Maximum score: 110.
Higher scores indicate better cognitive processing speed.
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Baseline and 8 weeks
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California Verbal Learning Test-II (CVLT-II)
大体时间:Baseline and 8 weeks
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Part of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery.
Assesses auditory and verbal memory.
A list of 16 words across 4 categories is read aloud and recalled over 5 trials.
Minimum score: 0, Maximum score: 80. Higher scores indicate better verbal learning and memory.
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Baseline and 8 weeks
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Brief Visuospatial Memory Test-Revised (BVMT-R)
大体时间:Baseline and 8 weeks
|
Part of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery.
Assesses visuospatial memory.
Six geometric figures are presented and participants are asked to reproduce them from memory.
Minimum score: 0, Maximum score: 36.
Higher scores indicate better visuospatial memory.
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Baseline and 8 weeks
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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。
调查人员
- 首席研究员:Yeliz SALCI、Hacettepe University
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 (估计的)
2026年7月1日
初级完成 (估计的)
2028年6月1日
研究完成 (估计的)
2028年6月1日
研究注册日期
首次提交
2026年5月5日
首先提交符合 QC 标准的
2026年5月5日
首次发布 (实际的)
2026年5月11日
研究记录更新
最后更新发布 (实际的)
2026年5月20日
上次提交的符合 QC 标准的更新
2026年5月18日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- FTREK26/19
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
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不
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