NCT06462339

Brief Summary

Multiple sclerosis (MS) is a chronic, inflammatory, degenerative disease of the central nervous system, causing demyelination and axonal damage. MS typically begins with attacks resulting from demyelination of axons, eventually evolving into a neurodegenerative disease associated with neurotrophic support deficiency and neuronal loss. Depending on the location and degeneration, various neurological disorders and symptoms such as walking and balance problems, fatigue, sensory loss, and cognitive impairments are observed in MS patients. Cognitive impairments in MS are associated with lesion count, localization, axonal loss, and brain atrophy, affecting approximately 50-60% of patients. Patients exhibit impairments in verbal fluency, visual-spatial memory, processing speed, executive functions, and episodic memory. Cognitive impairments also lead to a decrease in dual-task performance, referred to as the ability to perform two tasks simultaneously, in MS patients. Cognitive problems and impaired dual-task performance negatively impact various aspects of daily life, including social participation and employment status, thus reducing their quality of life. Clinical-based exercise interventions are frequently utilized and effective in improving cognitive functions and dual-task performance in MS. Pilates is a commonly used exercise modality in clinical practice. Pilates is a core stability-based exercise method involving endurance, flexibility, movement, posture, and respiratory control. Previous studies have indicated that clinical Pilates improves cognitive functions. On the other hand, telerehabilitation approaches, the use of which has increased rapidly due to technological developments in recent times, enable the delivery of rehabilitation services to patients in distant places by using communication technologies. For this purpose, it is highly valuable to implement Pilates, which consists of core stability exercise content, through telerehabilitation. While there are studies on clinical-based Pilates interventions, no study has investigated the efficacy of one-on-one online Pilates exercises on cognitive functions and dual-task performance in an online platform. Therefore, this study aims to investigate the effects of online Pilates on cognitive functions and dual-task performance in patients with MS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

June 28, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2024

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

May 24, 2024

Last Update Submit

March 17, 2025

Conditions

Keywords

Multiple SclerosisCognitive FunctionDual-taskPilatesTelerehabilitation

Outcome Measures

Primary Outcomes (27)

  • Mini-Mental test-Baseline

    Mini Mental Test (MMT) consists of eleven items grouped under five main headings: orientation, recording memory, attention and calculation, recall and language, and is evaluated out of a total score of 30. Accordingly, getting 24 points and above is considered normal.

    Assessment will be conducted before the intervention

  • Mini-Mental test-Post intervention

    Mini Mental Test (MMT) consists of eleven items grouped under five main headings: orientation, recording memory, attention and calculation, recall and language, and is evaluated out of a total score of 30. Accordingly, getting 24 points and above is considered normal.

    Assessment will be conducted immediately after the intervention

  • Montreal Cognitive Assessment-Baseline

    The Montreal Cognitive Assessment (MoCA) was developed as a rapid screening test for mild cognitive impairment. MoCA evaluates different cognitive functions. These; attention and concentration, executive functions, memory, language, visual structuring skills, abstract thinking, calculation and orientation. The highest total score that can be obtained from the test is 30. Higher scores mean a better outcome.

    Assessment will be conducted before the intervention

  • Montreal Cognitive Assessment-Post intervention

    The Montreal Cognitive Assessment (MoCA) was developed as a rapid screening test for mild cognitive impairment. MoCA evaluates different cognitive functions. These; attention and concentration, executive functions, memory, language, visual structuring skills, abstract thinking, calculation and orientation. The highest total score that can be obtained from the test is 30. Higher scores mean a better outcome.

    Assessment will be conducted immediately after the intervention

  • Trail Making Test-Baseline

    Trail Making Test (TMT) is used to evaluate individuals' executive functions, task-sequence switching ability, attention, visual scanning speed, visual-motor perception, planning, organization, abstract thinking and reaction limitation. The test consists of 2 parts: A and B. In part A, the individual is asked to combine numbers from 1 to 25 and the completion time is recorded. In part B, the individual completes the sequence corresponding to a number and a letter respectively, and the completion time is recorded.

    Assessment will be conducted before the intervention

  • Trail Making Test-Post intervention

    Trail Making Test (TMT) is used to evaluate individuals' executive functions, task-sequence switching ability, attention, visual scanning speed, visual-motor perception, planning, organization, abstract thinking and reaction limitation. The test consists of 2 parts: A and B. In part A, the individual is asked to combine numbers from 1 to 25 and the completion time is recorded. In part B, the individual completes the sequence corresponding to a number and a letter respectively, and the completion time is recorded.

    Assessment will be conducted immediately after the intervention

  • Stroop Test-Baseline

    Stroop Test, one of the neuropsychological tests, is used to evaluate selective attention, information processing speed and cognitive flexibility. The test consists of three parts. The first section contains words written in black (e.g. 'blue'), the second section contains colors, and the last section contains words written in different colors (e.g. the word blue written in red ink). The participant is expected to fulfill the tasks in these three sections respectively. While keeping time for each part, the participant must read the words correctly at first, say the colors in the next part, and say the color in which the word is written in the last part. In the test, reading time, number of errors made and number of spontaneous corrections are recorded.

    Assessment will be conducted before the intervention

  • Stroop Test-Post intervention

    Stroop Test, one of the neuropsychological tests, is used to evaluate selective attention, information processing speed and cognitive flexibility. The test consists of three parts. The first section contains words written in black (e.g. 'blue'), the second section contains colors, and the last section contains words written in different colors (e.g. the word blue written in red ink). The participant is expected to fulfill the tasks in these three sections respectively. While keeping time for each part, the participant must read the words correctly at first, say the colors in the next part, and say the color in which the word is written in the last part. In the test, reading time, number of errors made and number of spontaneous corrections are recorded.

    Assessment will be conducted immediately after the intervention

  • Functional mobility-baseline

    Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again.

    Assessment will be conducted before the intervention

  • Dual task performance in functional mobility, Cognitive additional task (arithmetic)-baseline

    Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again. Cognitive additional task (arithmetic): Individuals will be asked to perform tasks by counting backward from 3 to 3 from 100.

    Assessment will be conducted before the intervention

  • Dual task performance in functional mobility, Cognitive additional task (verbal)-baseline

    Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again. Cognitive additional task (verbal): Individuals will be asked to fulfill their duties by producing name.

    Assessment will be conducted before the intervention

  • functional mobility-post intervention

    Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again.

    Assessment will be conducted immediately after the intervention

  • Dual task performance in functional mobility, Cognitive additional task (arithmetic)-post intervention

    Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again. Cognitive additional task (arithmetic): Individuals will be asked to perform tasks by counting backward from 3 to 3 from 100.

    Assessment will be conducted immediately after the intervention

  • Dual task performance in functional mobility, Cognitive additional task (verbal)-post intervention

    Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again. Cognitive additional task (verbal): Individuals will be asked to fulfill their duties by producing name.

    Assessment will be conducted immediately after the intervention

  • balance-baseline

    The posturography (Biodex Balance System-BioSwayTM) will be used to assess postural stability.

    Assessment will be conducted before the intervention

  • balance, Cognitive additional task (arithmetic)-baseline

    The posturography (Biodex Balance System-BioSwayTM) will be used to assess postural stability. Cognitive additional task (arithmetic)

    Assessment will be conducted before the intervention

  • Dual task performance in balance, Cognitive additional task (verbal)-baseline

    The posturography (Biodex Balance System-BioSwayTM) will be used to assess postural stability. Cognitive additional task (verbal)

    Assessment will be conducted before the intervention

  • Dual task performance in balance,Cognitive additional task (arithmetic)-post intervention

    The posturography (Biodex Balance System-BioSwayTM) will be used to assess postural stability. Cognitive additional task (arithmetic)

    Assessment will be conducted immediately after the intervention

  • balance-post intervention

    The posturography (Biodex Balance System-BioSwayTM) will be used to assess postural stability.

    Assessment will be conducted immediately after the intervention

  • Dual task performance in balance,Cognitive additional task (arithmetic) -post intervention

    The posturography (Biodex Balance System-BioSwayTM) will be used to assess postural stability. Cognitive additional task (arithmetic)

    Assessment will be conducted immediately after the intervention

  • Dual task performance in balance,Cognitive additional task (verbal) -post intervention

    The posturography (Biodex Balance System-BioSwayTM) will be used to assess postural stability. Cognitive additional task (verbal)

    Assessment will be conducted immediately after the intervention

  • gait-baseline

    Wearable system (G-Walk) will be used to assess gait parameters.

    Assessment will be conducted before the intervention

  • Dual task performance in gait, Cognitive additional task (arithmetic)-baseline

    Wearable system (G-Walk) will be used to assess gait parameters. Cognitive additional task (arithmetic)

    Assessment will be conducted before the intervention

  • Dual task performance in gait, Cognitive additional task (verbal)-baseline

    Wearable system (G-Walk) will be used to assess gait parameters. Cognitive additional task (verbal)

    Assessment will be conducted before the intervention

  • gait-post intervention

    Wearable system (G-Walk) will be used to assess gait parameters.

    Assessment will be conducted immediately after the intervention

  • Dual task performance in gait, Cognitive additional task (arithmetic)-post intervention

    Wearable system (G-Walk) will be used to assess gait parameters. Cognitive additional task (arithmetic)

    Assessment will be conducted immediately after the intervention

  • Dual task performance in gait, Cognitive additional task (verbal)-post intervention

    Wearable system (G-Walk) will be used to assess gait parameters. Cognitive additional task (verbal)

    Assessment will be conducted immediately after the intervention

Study Arms (2)

Pilates training via telerehabilitation

EXPERIMENTAL

The intervention group will be received online pilates training three times a week for 6 weeks.

Behavioral: Experimental: Intervention Group

Waitlist

NO INTERVENTION

The control group will be a wait-list group without any additional specific treatment.

Interventions

The group that will receive pilates training via telerehabilitation

Pilates training via telerehabilitation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Voluntarily participate in research to accept
  • Having a diagnosis of "Multiple Sclerosis" by a specialist physician
  • Relapse free in the last 3 mounts
  • An Expanded Disability Status Scale (EDSS) score: 0-5

You may not qualify if:

  • Any cardiovascular, orthopedic, visual, hearing, and perception problems that may affect the results of the research
  • Having a cardiovascular, pulmonary or hormonal disorder that would prevent exercise
  • Having an accompanying neurological disorder other than MS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Abasiyanik Z, Ertekin O, Kahraman T, Yigit P, Ozakbas S. The effects of Clinical Pilates training on walking, balance, fall risk, respiratory, and cognitive functions in persons with multiple sclerosis: A randomized controlled trial. Explore (NY). 2020 Jan-Feb;16(1):12-20. doi: 10.1016/j.explore.2019.07.010. Epub 2019 Jul 17.

    PMID: 31377306BACKGROUND
  • Ozkul C, Guclu-Gunduz A, Eldemir K, Apaydin Y, Yazici G, Irkec C. Combined exercise training improves cognitive functions in multiple sclerosis patients with cognitive impairment: A single-blinded randomized controlled trial. Mult Scler Relat Disord. 2020 Oct;45:102419. doi: 10.1016/j.msard.2020.102419. Epub 2020 Jul 23.

    PMID: 32736216BACKGROUND
  • Eldemir K, Eldemir S, Ozkul C, Irkec C, Guclu-Gunduz A. The effects of online pilates training on cognitive functions and dual task performance in people with multiple sclerosis: A randomized controlled study. Mult Scler Relat Disord. 2025 May;97:106393. doi: 10.1016/j.msard.2025.106393. Epub 2025 Mar 17.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kader Eldemir, PT, MSc.

    Ordu University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups as exercise group and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2024

First Posted

June 17, 2024

Study Start

June 28, 2024

Primary Completion

September 12, 2024

Study Completion

November 12, 2024

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data but when the statistical analysis of all data are made, all results will be shared

Locations