Clinical trial NCT06462339: The Effect of Online Pilates on Cognitive Function and Dual-Task Performance
Official title: Investigation of the Effects of Online Pilates Training on Cognitive Functions and Dual-Task Performance in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Cognitive Function
Dual-task
Pilates
Telerehabilitation
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups as exercise group and control group
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mini-Mental test-Baseline
timeFrame: Assessment will be conducted before the intervention
measure: Mini-Mental test-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Montreal Cognitive Assessment-Baseline
timeFrame: Assessment will be conducted before the intervention
measure: Montreal Cognitive Assessment-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Trail Making Test-Baseline
timeFrame: Assessment will be conducted before the intervention
measure: Trail Making Test-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Stroop Test-Baseline
timeFrame: Assessment will be conducted before the intervention
measure: Stroop Test-Post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Functional mobility-baseline
timeFrame: Assessment will be conducted before the intervention
measure: Dual task performance in functional mobility, Cognitive additional task (arithmetic)-baseline
timeFrame: Assessment will be conducted before the intervention
measure: Dual task performance in functional mobility, Cognitive additional task (verbal)-baseline
timeFrame: Assessment will be conducted before the intervention
measure: functional mobility-post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Dual task performance in functional mobility, Cognitive additional task (arithmetic)-post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Dual task performance in functional mobility, Cognitive additional task (verbal)-post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: balance-baseline
timeFrame: Assessment will be conducted before the intervention
measure: balance, Cognitive additional task (arithmetic)-baseline
timeFrame: Assessment will be conducted before the intervention
measure: Dual task performance in balance, Cognitive additional task (verbal)-baseline
timeFrame: Assessment will be conducted before the intervention
measure: Dual task performance in balance,Cognitive additional task (arithmetic)-post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: balance-post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Dual task performance in balance,Cognitive additional task (arithmetic) -post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Dual task performance in balance,Cognitive additional task (verbal) -post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: gait-baseline
timeFrame: Assessment will be conducted before the intervention
measure: Dual task performance in gait, Cognitive additional task (arithmetic)-baseline
timeFrame: Assessment will be conducted before the intervention
measure: Dual task performance in gait, Cognitive additional task (verbal)-baseline
timeFrame: Assessment will be conducted before the intervention
measure: gait-post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Dual task performance in gait, Cognitive additional task (arithmetic)-post intervention
timeFrame: Assessment will be conducted immediately after the intervention
measure: Dual task performance in gait, Cognitive additional task (verbal)-post intervention
timeFrame: Assessment will be conducted immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Ordu University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
name: Kader Eldemir, PT, MSc.
role: STUDY_CHAIR
References:
citation: 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.
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.