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

14. september 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Anslået)

70

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
6-Minute Walk Test
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Timed 25-Step Walking Test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Suleyman Demirel University

Efterforskere

  • Studieleder: MELİKE DOĞAN ÜNLÜ, NEUROLOGIST ASSOCIATE PROFESSO, Suleyman Demirel University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. september 2026

Primær færdiggørelse (Anslået)

15. januar 2027

Studieafslutning (Anslået)

15. maj 2027

Datoer for studieregistrering

Først indsendt

7. september 2026

Først indsendt, der opfyldte QC-kriterier

7. september 2026

Først opslået (Faktiske)

11. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SüleymanDU-126/9

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

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