- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06462339
The Effect of Online Pilates on Cognitive Function and Dual-Task Performance
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey
- Gazi University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waitlist
The control group will be a wait-list group without any additional specific treatment.
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Experimental: Pilates training via telerehabilitation
The intervention group will be received online pilates training three times a week for 6 weeks.
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The group that will receive pilates training via telerehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini-Mental test-Baseline
Time Frame: Assessment will be conducted before the 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 before the intervention
|
|
Mini-Mental test-Post intervention
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted before the 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 before the intervention
|
|
Montreal Cognitive Assessment-Post intervention
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted before the 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 before the intervention
|
|
Trail Making Test-Post intervention
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted before the 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 before the intervention
|
|
Stroop Test-Post intervention
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted before the 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 before the intervention
|
|
Dual task performance in functional mobility, Cognitive additional task (arithmetic)-baseline
Time Frame: Assessment will be conducted before the 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 before the intervention
|
|
Dual task performance in functional mobility, Cognitive additional task (verbal)-baseline
Time Frame: Assessment will be conducted before the 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 before the intervention
|
|
functional mobility-post intervention
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted before the intervention
|
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
Time Frame: Assessment will be conducted before the intervention
|
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
Time Frame: Assessment will be conducted before the intervention
|
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
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted before the intervention
|
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
Time Frame: Assessment will be conducted before the intervention
|
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
Time Frame: Assessment will be conducted before the intervention
|
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
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted immediately after the 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
Time Frame: Assessment will be conducted immediately after the intervention
|
Wearable system (G-Walk) will be used to assess gait parameters.
Cognitive additional task (verbal)
|
Assessment will be conducted immediately after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Kader Eldemir, PT, MSc., Ordu University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- MS-Cognition-Onlinepilates
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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