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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462339
• Other study ID #: MS-Cognition-Onlinepilates
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 6, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2024
• Source: Gazi University
• Contact: Kader Eldemir, PT, MSc.
• Phone: +90452226 52 00
• Email: fztkader2015[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Experimental: Intervention Group
The group that will receive pilates training via telerehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	balance-baseline	The posturography (Biodex Balance System-BioSwayTM) will be used to assess postural stability.	Assessment will be conducted before the intervention
Primary	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
Primary	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
Primary	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
Primary	balance-post intervention	The posturography (Biodex Balance System-BioSwayTM) will be used to assess postural stability.	Assessment will be conducted immediately after the intervention
Primary	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
Primary	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
Primary	gait-baseline	Wearable system (G-Walk) will be used to assess gait parameters.	Assessment will be conducted before the intervention
Primary	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
Primary	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
Primary	gait-post intervention	Wearable system (G-Walk) will be used to assess gait parameters.	Assessment will be conducted immediately after the intervention
Primary	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
Primary	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