- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07815990
Aerobic Fitness in Multiple Sclerosis: The Relationship Between Balance and Sensory Dual-Tasking
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: ALEYNA OZDAMAR YUCEL, MSc
- Phone Number: +90 507 950 74 57
- Email: aleynayucel@sdu.edu.tr
Study Contact Backup
- Name: MEHMET DURAY, associate professor
- Phone Number: +90 506 473 11 65
- Email: mehmetduray@sdu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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).
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-Minute Walk Test
Time Frame: once
|
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.
|
once
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed 25-Step Walking Test
Time Frame: once
|
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.
|
once
|
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Dual Task Performance Test: Standing (Static Balance) Tasks
Time Frame: once
|
|
once
|
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Dual Task Performance Test: Walking (Dynamic Balance) Tasks
Time Frame: once
|
|
once
|
|
Berg Balance Scale
Time Frame: once
|
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.
|
once
|
|
Activity-Specific Balance Confidence Scale
Time Frame: once
|
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.
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once
|
|
Modified Fatigue Impact Scale
Time Frame: once
|
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.
|
once
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: MELİKE DOĞAN ÜNLÜ, NEUROLOGIST ASSOCIATE PROFESSO, Suleyman Demirel University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SüleymanDU-126/9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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