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The Effects of Pilates-Based Core Stabilization Training in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates Based Core Stabilization Training
Home based exercise
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Pilates, Core stability, Isokinetic strength, Postural sway

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being diagnosed with MS according to McDonald's criteria
  • Disability level less than 6 according to EDSS (Expanded Disability Status Scale) score
  • No attacks during the last 3 months
  • Being an ambulatory
  • Volunteering to participate in the study

Exclusion Criteria:

  • Having orthopedic, neurological, psychological, etc. diseases that accompany MS and may affect treatment outcomes
  • Doing regular sports
  • Being involved in another physiotherapy and rehabilitation program related to MS

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Supervised Pilates-Based Core Stability Training Group

Home exercise group

Arm Description

In order to detect the effects of pilates-based core stabilization training (PBCST) on isokinetic knee strength and postural sways, individuals with MS will receive pilates-based core stabilization training for 8 weeks and 2 days a week. One educational session will perform to teach basic principles of pilates based training. Individuals in this group will receive treatment at the clinic by physiotherapist supervision. All sessions will be individualized (not group training).

The home exercise group will perform the same PBCST exercises at home during the same period (8 weeks, 2 days a week) as the brochures prepared for them. Individuals in this group will receive one educational session which includes basic principles of pilates and one session which includes two-week exercise program. Participants will be invited to the clinic every two weeks to ensure the progression of the exercises and the exercise program will be updated.

Outcomes

Primary Outcome Measures

Isokinetic strength
Concentric isokinetic muscle strength of the knee flexor and extensor muscles will be evaluated at angular velocities of 30,60 and 90°/s.
Postural sways
Postural sways will be evaluated with biodex balance system in different condition such as open eyes on firm and foam surface, closed eyes on firm and foam surface, tandem stance on firm and foam surface,

Secondary Outcome Measures

Core strength
Core strength will be evaluated within the scope of core assessment. Curl-Up and Modified Push-Up test will be used for the evaluation of core strength.
Core endurance
Core endurance will be evaluated within the scope of core assessment. Trunk Flexor Endurance Test, Trunk Extensor Endurance Test, Trunk Lateral Endurance Test and Plank Test will be used in the evaluation of core endurance.
Balance
Berg Balance Scale (BBS) will be used to evaluate balance. BBS is a test developed for functional evaluation of balance in adults. BBS consists of 14 general equilibrium activities that change the orientation of the body center of gravity relative to the support surface and the ability to maintain the static position during the reduction of the support surface. The highest score is 56. The decrease in the score indicates poorer balance.
Mobility
Two-minute walk test (2-MWT) will be used to evaluate the mobility of the people with MS. 2-MWT is a measure of self-paced walking ability and functional capacity.
Fatigue
Fatigue Severity Scale (FSS) will be used to evaluate fatigue levels. This scale evaluates the severity of fatigue with 9 questions. Each question scores between 1 (I do not agree) and 7 (fully agree). The FSS score is the average value of nine sections. A high score indicates increased fatigue severity.
Quality of life
Multiple Sclerosis Quality of Life -54 (MSQOL-54) will be used to evaluate the effectiveness of the treatment on quality of life. The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument.
Fall risk
Timed Up and Go (TUG) will be used. TUG is a test used to determine fall risk and measure the progress of balance, sit to stand and walking.

Full Information

First Posted
January 27, 2020
Last Updated
January 6, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04252053
Brief Title
The Effects of Pilates-Based Core Stabilization Training in Multiple Sclerosis
Official Title
The Effects of Pilates-Based Core Stabilization Training on Isokinetic Knee Strength and Postural Sway in People With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
January 3, 2021 (Actual)
Study Completion Date
January 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multiple Sclerosis (MS) is a chronic, autoimmune and neurodegenerative disease characterized by inflammation and progressive demyelination of the central nervous system. It is characterized by muscle weakness, balance and coordination disorder, which is more common in the lower extremities and trunk muscles. Over time, these symptoms decrease the individual's level of physical activity, mobility and quality of life, leading to further deterioration of the disorder. One of the most important problems that cause these problems in individuals with MS is reduced core stabilization. Decrease in core stabilization affects the quality of limb movements as well as trunk stability when considering the kinetic chain in the body. Pilates-based core stabilization training (PBCST) are a controlled exercise form used to improve the stabilization of trunk muscles. There are no studies on the effect of this training on lower extremity isokinetic muscle strength in individuals with MS. The aim of this study is to determine the effect of PBCST on lower extremity muscle strength, postural sway and kinetic chain in individuals with MS.
Detailed Description
The study was planned as randomized controlled. Individuals included in the study wiil randomly allocate to the group receiving the supervised PBCST and the home exercise group. While the supervised exercise group receives PBCST for 2 days and 8 weeks in the clinic, the home exercise group will perform the same exercises at home for the same time as the brochures prepared for them. The exercise program will show progression at 2-week intervals. A session will be held for both groups to teach the basic principles of pilates and will not be counted in the 8-week program. At the beginning and end of treatment, individuals will be evaluated for isokinetic muscle strength, balance and postural sway, fatigue level, quality of life and functional capacity parameters. PBCST is thought to reduce postural sways and increase lower extremity muscle strength by increasing core stability with the effect of kinetic chain and increased stabilization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Pilates, Core stability, Isokinetic strength, Postural sway

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised Pilates-Based Core Stability Training Group
Arm Type
Experimental
Arm Description
In order to detect the effects of pilates-based core stabilization training (PBCST) on isokinetic knee strength and postural sways, individuals with MS will receive pilates-based core stabilization training for 8 weeks and 2 days a week. One educational session will perform to teach basic principles of pilates based training. Individuals in this group will receive treatment at the clinic by physiotherapist supervision. All sessions will be individualized (not group training).
Arm Title
Home exercise group
Arm Type
Active Comparator
Arm Description
The home exercise group will perform the same PBCST exercises at home during the same period (8 weeks, 2 days a week) as the brochures prepared for them. Individuals in this group will receive one educational session which includes basic principles of pilates and one session which includes two-week exercise program. Participants will be invited to the clinic every two weeks to ensure the progression of the exercises and the exercise program will be updated.
Intervention Type
Other
Intervention Name(s)
Pilates Based Core Stabilization Training
Intervention Description
Pilates-based core stabilization training (PBCST) is a controlled form of exercise provided improvement in stabilization of abdominal and back muscles.
Intervention Type
Other
Intervention Name(s)
Home based exercise
Intervention Description
Home exercises which include pilates based core stabilization training will be structured for the people with MS according to their physical condition and will perform at home by them.
Primary Outcome Measure Information:
Title
Isokinetic strength
Description
Concentric isokinetic muscle strength of the knee flexor and extensor muscles will be evaluated at angular velocities of 30,60 and 90°/s.
Time Frame
8 weeks
Title
Postural sways
Description
Postural sways will be evaluated with biodex balance system in different condition such as open eyes on firm and foam surface, closed eyes on firm and foam surface, tandem stance on firm and foam surface,
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Core strength
Description
Core strength will be evaluated within the scope of core assessment. Curl-Up and Modified Push-Up test will be used for the evaluation of core strength.
Time Frame
8 weeks
Title
Core endurance
Description
Core endurance will be evaluated within the scope of core assessment. Trunk Flexor Endurance Test, Trunk Extensor Endurance Test, Trunk Lateral Endurance Test and Plank Test will be used in the evaluation of core endurance.
Time Frame
8 weeks
Title
Balance
Description
Berg Balance Scale (BBS) will be used to evaluate balance. BBS is a test developed for functional evaluation of balance in adults. BBS consists of 14 general equilibrium activities that change the orientation of the body center of gravity relative to the support surface and the ability to maintain the static position during the reduction of the support surface. The highest score is 56. The decrease in the score indicates poorer balance.
Time Frame
8 weeks
Title
Mobility
Description
Two-minute walk test (2-MWT) will be used to evaluate the mobility of the people with MS. 2-MWT is a measure of self-paced walking ability and functional capacity.
Time Frame
8 weeks
Title
Fatigue
Description
Fatigue Severity Scale (FSS) will be used to evaluate fatigue levels. This scale evaluates the severity of fatigue with 9 questions. Each question scores between 1 (I do not agree) and 7 (fully agree). The FSS score is the average value of nine sections. A high score indicates increased fatigue severity.
Time Frame
8 weeks
Title
Quality of life
Description
Multiple Sclerosis Quality of Life -54 (MSQOL-54) will be used to evaluate the effectiveness of the treatment on quality of life. The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument.
Time Frame
8 weeks
Title
Fall risk
Description
Timed Up and Go (TUG) will be used. TUG is a test used to determine fall risk and measure the progress of balance, sit to stand and walking.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being diagnosed with MS according to McDonald's criteria Disability level less than 6 according to EDSS (Expanded Disability Status Scale) score No attacks during the last 3 months Being an ambulatory Volunteering to participate in the study Exclusion Criteria: Having orthopedic, neurological, psychological, etc. diseases that accompany MS and may affect treatment outcomes Doing regular sports Being involved in another physiotherapy and rehabilitation program related to MS
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey

12. IPD Sharing Statement

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The Effects of Pilates-Based Core Stabilization Training in Multiple Sclerosis

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