AzTrials
AzTrials

Multiple SclerosisNCT06462339

The Effect of Online Pilates on Cognitive Function and Dual-Task Performance

A study testing Experimental: Intervention Group in people with Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Experimental: Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 Jun 2024to 12 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-65 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gazi University

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Online Pilates Training on Cognitive Functions and Dual-Task Performance in Multiple Sclerosis Patients

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.

Read the detailed description

This study is a randomized controlled study. The patients will be randomly divided into two groups exercise and control. Pilates exercises consisting of 3 days a week for 6 weeks will be given to the exercise group.

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

All assessments will be done before and after the 6-week intervention program or waiting period. The demographic characteristics of the participants initially will be taken and the Expanded Disability Status Scale score of those of MS will be recorded. As the outcome measures, cognitive functions and dual-task performance will be evaluated.

Being tested
Experimental: Intervention Group
Keywords
Multiple Sclerosis, Cognitive Function, Dual-task, Pilates, Telerehabilitation
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Intervention GroupBehavioural

    The group that will receive pilates training via telerehabilitation

Study groups in NCT06462339
Study groupRoleWhat they receive
Pilates training via telerehabilitationExperimentalThe intervention group will be received online pilates training three times a week for 6 weeks.
Receives: Behavioral: Experimental: Intervention Group
WaitlistNo interventionThe control group will be a wait-list group without any additional specific treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assessment will be conducted before the intervention

  2. 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.

    Measured: Assessment will be conducted immediately after the intervention

  3. 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.

    Measured: Assessment will be conducted before the intervention

  4. 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.

    Measured: Assessment will be conducted immediately after the intervention

  5. 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.

    Measured: Assessment will be conducted before the intervention

  6. 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.

    Measured: Assessment will be conducted immediately after the intervention

  7. 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.

    Measured: Assessment will be conducted before the intervention

  8. 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.

    Measured: Assessment will be conducted immediately after the intervention

  9. 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.

    Measured: Assessment will be conducted before the intervention

  10. 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.

    Measured: Assessment will be conducted before the intervention

  11. 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.

    Measured: Assessment will be conducted before the intervention

  12. 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.

    Measured: Assessment will be conducted immediately after the intervention

  13. 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.

    Measured: Assessment will be conducted immediately after the intervention

  14. 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.

    Measured: Assessment will be conducted immediately after the intervention

  15. balance-baseline

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

    Measured: Assessment will be conducted before the intervention

  16. balance, Cognitive additional task (arithmetic)-baseline

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

    Cognitive additional task (arithmetic)

    Measured: Assessment will be conducted before the intervention

  17. 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)

    Measured: Assessment will be conducted before the intervention

  18. 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)

    Measured: Assessment will be conducted immediately after the intervention

  19. balance-post intervention

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

    Measured: Assessment will be conducted immediately after the intervention

  20. 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)

    Measured: Assessment will be conducted immediately after the intervention

  21. 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)

    Measured: Assessment will be conducted immediately after the intervention

  22. gait-baseline

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

    Measured: Assessment will be conducted before the intervention

  23. 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)

    Measured: Assessment will be conducted before the intervention

  24. 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)

    Measured: Assessment will be conducted before the intervention

  25. gait-post intervention

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

    Measured: Assessment will be conducted immediately after the intervention

  26. 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)

    Measured: Assessment will be conducted immediately after the intervention

  27. 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)

    Measured: Assessment will be conducted immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2024
  2. Study start28 Jun 2024
  3. Primary completion12 Sep 2024
  4. Study completion12 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups as exercise group and control group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06462339
Sponsor's protocol ID
MS-Cognition-Onlinepilates
Status last verified
Mar 2025
First submitted
24 May 2024
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • 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.

    PubMed 31377306
  • 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.

    PubMed 32736216
  • 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.

    PubMed 40120159

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Intervention Group in people with Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mini-Mental test-Baseline (time frame: Assessment will be conducted before the intervention). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06462339, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in