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Aerobic Fitness in Multiple Sclerosis: The Relationship Between Balance and Sensory Dual-Tasking

2026年9月14日 更新者：Aleyna Özdamar Yücel、Suleyman Demirel University

The Effect of Aerobic Fitness on Balance-Related Sensory Dual-Task Performance in Patients With Multiple Sclerosis

The aim of this study is to comparatively examine the effect of aerobic fitness levels on walking and balance performance, sensory dual-task (proprioceptive and vestibular) performance, balance confidence, and fatigue levels in individuals diagnosed with MS.

Research hypotheses H1: MS patients with high aerobic fitness exhibit superior walking speed and balance performance compared to MS patients with low aerobic fitness.

H2: In sensory dual-task tests involving proprioceptive and vestibular manipulations (BOSU ball, soft surface, and head movements synchronized with a metronome), MS patients with high aerobic fitness demonstrate better performance than the group with low aerobic fitness.

H3: MS patients with high aerobic fitness report higher levels of balance confidence compared to the group with low aerobic fitness.

H4: Perceived fatigue is greater in MS patients with low aerobic fitness compared to the group with high aerobic fitness.

H5: There is a significant relationship between aerobic capacity levels and sensory dual-task performance, balance confidence, and fatigue severity in MS patients.

研究概览

地位

尚未招聘

条件

详细说明

The study will be conducted on volunteer patients diagnosed with multiple sclerosis by a specialist physician in the Department of Neurology of Isparta Süleyman Demirel University Hospital. All stages of the study will be conducted at Isparta Süleyman Demirel University. Informed consent form will be obtained from all patients participating in the study.The research protocol consists of two main phases. In Phase 1, "Basic Assessment and Grouping," participants' aerobic fitness will be determined using the 6-Minute Walk Test (6MWT). Based on the walking distance results, the sample will be divided into two groups: "Group 1: Those with High Aerobic Fitness" and "Group 2: Those with Low Aerobic Fitness."In Phase 2, the "Joint Clinical and Dual Task Protocol," data will be collected using a Personal Information Form, the Timed 25-Step Walk Test (T25WWT), the Timed Up and Walk Test (TUWT), the Berg Balance Scale (BBS), the Modified Clinical Sensory Interaction Test (MCIT), the Activity-Specific Balance Confidence Scale (ASBCS), and the Modified Fatigue Impact Scale (MFIS).

研究类型

观察性的

注册 (估计的)

70

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

研究联系人备份

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

取样方法

概率样本

研究人群

This study was planned as a cross-sectional study, and the target population of the research consists of individuals diagnosed with MS and followed up in Isparta province.

描述

Inclusion Criteria:

  • Having been diagnosed with Relapsing-Remitting or Progressive MS.
  • Being between 18-65 years of age.
  • Having an Expanded Disability Status Scale score between 1.5-5.
  • Being able to walk independently or with a unilateral assistive device.
  • Having full cooperation and orientation, and a cognitive level to understand given commands: Mini Mental Test score of 24 or higher.

Exclusion Criteria:

  • Having experienced an MS relapse or received acute corticosteroid treatment within the last 3 months.
  • Having an additional neurological, orthopedic, or rheumatological condition unrelated to MS that may affect balance and walking.
  • Having severe cardiovascular or respiratory disease that may make aerobic fitness assessment risky.
  • Having significant vision or hearing loss that would impede understanding test instructions.
  • Experiencing significant pain during measurements.
  • Having cognitive impairment that would prevent understanding or answering questions - scoring below 24 on the Minimental Test.

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

队列和干预

团体/队列
Those with High Aerobic Fitness: Joint Clinical and Dual Duty Protocol
Data will be collected once using a Personal Information Form, the Timed 25-Step Walk Test (T25WWT), the Timed Up and Walk Test (TUWT), the Berg Balance Scale (BBS), the Modified Clinical Sensory Interaction Test (MCIET), the Activity-Specific Balance Confidence Scale (ASBCS), and the Modified Fatigue Impact Scale (MFIS).
Individuals with Low Aerobic Fitness: Joint Clinical and Dual Duty Protocol
Data will be collected once using a Personal Information Form, the Timed 25-Step Walk Test (T25WWT), the Timed Up and Walk Test (TUWT), the Berg Balance Scale (BBS), the Modified Clinical Sensory Interaction Test (MCIET), the Activity-Specific Balance Confidence Scale (ASBCS), and the Modified Fatigue Impact Scale (MFIS).

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
6-Minute Walk Test
大体时间：Day 1
Participants' aerobic fitness, walking endurance, and functional exercise capacity will be assessed using the 6DKYT. Participants are asked to walk for 6 minutes at their own determined maximum safe pace in a 30-meter straight corridor, and the total distance covered is recorded in meters.
Day 1

次要结果测量

结果测量
措施说明
大体时间
Timed 25-Step Walking Test
大体时间：Day 1
To assess participants' baseline walking performance and speed, the Z25AYT, a subtest of the universal Multiple Sclerosis Functional Composite Battery, will be administered. Participants will be asked to walk a distance of 25 steps (approximately 7.62 meters) as quickly and safely as possible, and the elapsed time will be measured with a stopwatch and recorded in seconds.
Day 1
Dual Task Performance Test: Standing (Static Balance) Tasks
大体时间：Day 1
  1. Proprioceptive Task: The goal is to restrict/modify the proprioceptive inputs from the participant's support surface. For this purpose, the participant is asked to stand on an unstable surface (BOSU ball) to examine the effect of uncertainty in deep sensory inputs on static postural control.
  2. Vestibular Task: The participant's proprioceptive inputs are stabilized by having them stand on a hard, stable surface. The role of the vestibular system in balance is assessed by having the participant stand while making rhythmic head movements (accompanied by a metronome). Thus, by manipulating the inputs from the vestibular apparatus, the stability of static balance, excluding visual and somatosensory inputs, is measured.
Day 1
Dual Task Performance Test: Walking (Dynamic Balance) Tasks
大体时间：Day 1
  1. Vestibular Task (GKST + Head Movement): During the standard GKST, participants will be asked to perform rhythmic head movements to the accompaniment of a metronome to assess the effect of the vestibular system on mobility.
  2. Proprioceptive Task (GKST + Soft Surface): To manipulate ground proprioception, the standard GKST protocol will be repeated on a soft foam surface of a specific density instead of a hard surface. This method will record walking stability and task completion time under conditions where proprioceptive feedback is limited.
Day 1
Berg Balance Scale
大体时间：Day 1
Participants' objective balance and fall risk will be measured using the BDI (Brain Stability Inventory). The scale consists of 14 different functional balance tasks, including sitting, standing, reaching, and turning, and is evaluated on a scale of 0-56 points. Lower scores indicate an increased risk of falls.
Day 1
Activity-Specific Balance Confidence Scale
大体时间：Day 1
The 16-item Fall Fear and Balance Confidence Scale (FDSS) will be administered to assess fall fear and balance confidence during daily living activities. The FDSS consists of 16 items scored between 0 and 100. Each item asks the individual to rate their confidence in their ability to maintain their balance without falling during a specific activity, on a scale of 0 (not confident at all) to 100 (completely confident). The total score is calculated by taking the arithmetic mean of all items, resulting in a value between 0 and 100. A higher total score indicates that the individual has high balance confidence and reduced fall fear during daily living activities.
Day 1
Modified Fatigue Impact Scale
大体时间：Day 1
To assess the impact of fatigue on physical, cognitive, and psychosocial functions, a 21-item fatigue risk assessment scale will be used. The fatigue risk assessment scale consists of 21 items that inquire about fatigue experiences over the past four weeks. Each item evaluates the impact of fatigue on daily life using a Likert-type scale ranging from 0 (never) to 4 (always). The total score obtainable from the scale ranges from 0 to 84. An increase in the total score indicates a greater negative impact of fatigue on the patient's physical, cognitive, and psychosocial functions, and a greater impact on quality of life.
Day 1

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。

赞助

Suleyman Demirel University

调查人员

  • 研究主任：MELİKE DOĞAN ÜNLÜ, NEUROLOGIST ASSOCIATE PROFESSO、Suleyman Demirel 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9月15日

初级完成 (估计的)

2027年1月15日

研究完成 (估计的)

2027年5月15日

研究注册日期

首次提交

2026年9月7日

首先提交符合 QC 标准的

2026年9月7日

首次发布 (实际的)

2026年9月11日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • SüleymanDU-126/9

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

The data for the primary and secondary objectives of the research will be compared after they are received.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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