The Effect of Telerehabilitation Based Pilates Training in Multiple Sclerosis Patients
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation-based Pilates Exercise
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Pilates, Exercise, Telerehabilitation, Physical performance, Balance, Gait, Fatigue
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 less than or equal to 4
Exclusion Criteria:
- Any cardiovascular, orthopedic, visual, hearing, and perception problems that may affect the results of the research.
Sites / Locations
- Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise group
Waitlist
Arm Description
The intervention group will be received telerehabilitation-based pilates training three times a week for 6 weeks.
The control group will be a wait-list group without any additional specific treatment.
Outcomes
Primary Outcome Measures
Dynamic Balance- Baseline
Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. (0 = worst,56 = best)
Dynamic Balance-Post intervention
Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. (0 = worst,56 = best)
Static Balance- Baseline
Biodex Balance System
Static Balance- Post intervention
Biodex Balance System
An individual's confidence in performing activities- Baseline
Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best)
An individual's confidence in performing activities- Post intervention
Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best)
Exercise capacity- Baseline
Six minute walk test
Exercise capacity- Post intervention
Six minute walk test
Gait parameters- Baseline
Wearable system (G-Walk)
Gait parameters- Post intervention
Wearable system (G-Walk)
Functional mobility- Baseline
Timed up go test
Functional mobility- Post intervention
Timed up go test
Core endurance- Baseline
Mcgill core endurance tests
Core endurance- Post intervention
Mcgill core endurance tests
Core strength- Baseline
Mcgill core strength tests
Core strength-Post intervention
Mcgill core strength tests
Muscle Strength outcomes- Baseline
Hand dynamometer (Baselineยฎ, White Plains, New York, US)
Muscle Strength outcomes- Post intervention
Hand dynamometer (Baselineยฎ, White Plains, New York, US)
Secondary Outcome Measures
Physical activity level- Baseline
international physical activity questionnaire (IPAQ). IPAQ assesses physical activity undertaken across a comprehensive set of domains including leisure time, domestic and gardening (yard) activities, work-related and transport-related activity. The items were structured to provide separate scores on walking; moderate-intensity; and vigorous-intensity activity as well as a combined total score to describe overall level of activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activity. (0 Metabolic equivalents (MET) minutes/week= worst, >3000 MET minutes/week= best)
Physical activity level- Post intervention
international physical activity questionnaire (IPAQ). IPAQ assesses physical activity undertaken across a comprehensive set of domains including leisure time, domestic and gardening (yard) activities, work-related and transport-related activity. The items were structured to provide separate scores on walking; moderate-intensity; and vigorous-intensity activity as well as a combined total score to describe overall level of activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activity. (0 Metabolic equivalents (MET) minutes/week= worst, >3000 MET minutes/week= best)
Fatigue severity- Baseline
Fatigue severity scale, A self-report scale is a 9-item scale which measures the severity of fatigue. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63 (9 = best, 63 = worst)
Fatigue severity- Post intervention
Fatigue severity scale, A self-report scale is a 9-item scale which measures the severity of fatigue. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63 (9 = best, 63 = worst)
Impact of fatigue on activities- Baseline
Fatigue impact scale. The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Answers are scored on a four point scale where 0 = no problem and 4 = extreme problem. (0 = best, 160 = worst)
Impact of fatigue on activities- Post intervention
Fatigue impact scale. The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Answers are scored on a four point scale where 0 = no problem and 4 = extreme problem. (0 = best, 160 = worst)
Health related quality of life- Baseline
Multiple Sclerosis Quality of Life (MSQOL)-54 scale.. There is no single overall score for the MSQOL-54. Two summary scores -physical health and mental health- can be derived from a weighted combination of scale scores. (0=worst, 100=best)
Health related quality of life- Post intervention- Post intervention
Multiple Sclerosis Quality of Life (MSQOL)-54 scale.. There is no single overall score for the MSQOL-54. Two summary scores -physical health and mental health- can be derived from a weighted combination of scale scores. (0=worst, 100=best)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04838886
Brief Title
The Effect of Telerehabilitation Based Pilates Training in Multiple Sclerosis Patients
Official Title
The Effect of Telerehabilitation Based Pilates Training on Physical Performance and Quality of Life in Multiple Sclerosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
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 inflammatory disease of the central nervous system characterized by myelin, oligodendrocyte, and axon damage. MS usually begins with attacks due to demyelination of axons in the brain, optic nerve, and spinal cord; over time it develops into a neurodegenerative disease associated with neurotrophic support deficiency and neuronal loss. In MS, various loss of strength, balance, fatigue, cognitive and gait disturbances arise in the central nervous system due to sensory and/or motor neuron degeneration. These disorders affect the quality of life by limiting the individual's activities and participation in their daily lives. Therefore, it is important to treat these disorders in the treatment of MS.
There are various pharmacological treatments and invasive procedures for the management of MS symptoms and one of the most commonly used treatment options is rehabilitation. Clinically-based exercise and rehabilitation are some of the most beneficial rehabilitation strategies in people with MS (PwMS). Clinically-based exercise and rehabilitation have been shown to stabilize or improve many physical symptoms of MS including loss of strength, balance dysfunction, impaired mobility, and fatigue. These benefits have led many practitioners to consider physical exercise as a nonpharmaceutical disease-modifying treatment. However, due to various factors such as mobility disorders, fatigue, and related problems, geographic location, time constraints, transportation difficulties, health insurance coverage, and financial burden, clinical-based exercise may be problematic in some pwMS. To overcome these challenges, approaches to rehabilitation have been developed such as telerehabilitation. The telerehabilitation system provides benefits such as continuity in patient education and rehabilitation, showing progress in rehabilitation, making changes in the treatment program, and saving individuals time and financial expenses. It is also an innovative and potential alternative to face-to-face interventions for treating disease-related disorders in pwMS. In literature, there are many studies examining the effectiveness of telerehabilitation in pwMS. According to these studies, ฤฑt has been shown that telerehabilitation, with its technical facilities, had the potential to make clinical interventions widely accessible and effective for MS, however, telerehabilitation-based interventions could not replace traditional interventions but could perfectly complement. It has been found that telerehabilitation improved balance and postural control in MS patients and had no side effects. However, it was emphasized that the evidence levels of the studies were insufficient for methodological reasons. It has been determined additional studies are needed to investigate examining the effect on walking.
Another clinical-based exercise method is Pilates. Pilates is a "core" stability-based exercise method that includes endurance, flexibility, movement, posture, and respiratory control. Studies have shown that Pilates training can improve balance, mobility, and muscle strength, fatigue in pwMS due to its structure consisting of balance and strengthening exercises. When the literature is reviewed in terms of Telerehabilitation based on Pilates in pwMS, it is seen that there are only two studies. In both studies, pwMS were given 20 minutes of yoga, 20 minutes of Pilates, and 20 minutes of dual-task exercise. However, these studies were in the project phase and the results are still not reported. On the other hand, in both studies, Pilates is given as combined training.
As a result, telerehabilitation is an alternative method to MS treatment. In addition, while there are many clinical-based Pilates studies in the literature, telerehabilitation-based Pilates studies are insufficient. Telerehabilitation-based Pilates training studies are needed. Therefore, the investigators planned this study to investigate the effect of telerehabilitation-based pilates training on physical performance and quality of life in pwMS.
Detailed Description
This study is planned as a randomized control trial. Patients will be randomly divided into two groups as intervention and control. The intervention group will be received telerehabilitation-based pilates training three times a week for six weeks. Telerehabilitation-based pilates will be provided via videoconferencing.
The first session will be the introduction session, patients will be informed about basic principles of Pilates and it will be included teaching inward movement of the lower abdominal wall and supine exercises of segmental movements involving trunk muscle recruitment to maintain a neutral posture. Afterward the session, a typical session will be included supine, side-lying, quadruped exercise, sitting on the exercise ball, and standing exercises. Exercises will be included thoracic extension, general abdominal strengthening, core stabilization exercises for the deep abdominal muscles. The difficulty of these exercises will be gradually increased and focused on keeping neutral positions of the spine in different gravity orientations. 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. Primary outcomes are balance, gait, core endurance and power, and muscle strength; secondary outcomes are physical activity, fatigue, and quality of life
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, Exercise, Telerehabilitation, Physical performance, Balance, Gait, Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention and control groups
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Description
The intervention group will be received telerehabilitation-based pilates training three times a week for 6 weeks.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
The control group will be a wait-list group without any additional specific treatment.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation-based Pilates Exercise
Intervention Description
The group that will receive telerehabilitation-based pilates training via telerehabilitation
Primary Outcome Measure Information:
Title
Dynamic Balance- Baseline
Description
Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. (0 = worst,56 = best)
Time Frame
Assessment will be conducted before the intervention
Title
Dynamic Balance-Post intervention
Description
Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. (0 = worst,56 = best)
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Static Balance- Baseline
Description
Biodex Balance System
Time Frame
Assessment will be conducted before the intervention.
Title
Static Balance- Post intervention
Description
Biodex Balance System
Time Frame
Assessment will be conducted immediately after the intervention.
Title
An individual's confidence in performing activities- Baseline
Description
Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best)
Time Frame
Assessment will be conducted before the intervention.
Title
An individual's confidence in performing activities- Post intervention
Description
Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best)
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Exercise capacity- Baseline
Description
Six minute walk test
Time Frame
Assessment will be conducted before the intervention.
Title
Exercise capacity- Post intervention
Description
Six minute walk test
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Gait parameters- Baseline
Description
Wearable system (G-Walk)
Time Frame
Assessment will be conducted before the intervention.
Title
Gait parameters- Post intervention
Description
Wearable system (G-Walk)
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Functional mobility- Baseline
Description
Timed up go test
Time Frame
Assessment will be conducted before the intervention.
Title
Functional mobility- Post intervention
Description
Timed up go test
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Core endurance- Baseline
Description
Mcgill core endurance tests
Time Frame
Assessment will be conducted before the intervention.
Title
Core endurance- Post intervention
Description
Mcgill core endurance tests
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Core strength- Baseline
Description
Mcgill core strength tests
Time Frame
Assessment will be conducted before the intervention.
Title
Core strength-Post intervention
Description
Mcgill core strength tests
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Muscle Strength outcomes- Baseline
Description
Hand dynamometer (Baselineยฎ, White Plains, New York, US)
Time Frame
Assessment will be conducted before the intervention.
Title
Muscle Strength outcomes- Post intervention
Description
Hand dynamometer (Baselineยฎ, White Plains, New York, US)
Time Frame
Assessment will be conducted immediately after the intervention.
Secondary Outcome Measure Information:
Title
Physical activity level- Baseline
Description
international physical activity questionnaire (IPAQ). IPAQ assesses physical activity undertaken across a comprehensive set of domains including leisure time, domestic and gardening (yard) activities, work-related and transport-related activity. The items were structured to provide separate scores on walking; moderate-intensity; and vigorous-intensity activity as well as a combined total score to describe overall level of activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activity. (0 Metabolic equivalents (MET) minutes/week= worst, >3000 MET minutes/week= best)
Time Frame
Assessment will be conducted before the intervention.
Title
Physical activity level- Post intervention
Description
international physical activity questionnaire (IPAQ). IPAQ assesses physical activity undertaken across a comprehensive set of domains including leisure time, domestic and gardening (yard) activities, work-related and transport-related activity. The items were structured to provide separate scores on walking; moderate-intensity; and vigorous-intensity activity as well as a combined total score to describe overall level of activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activity. (0 Metabolic equivalents (MET) minutes/week= worst, >3000 MET minutes/week= best)
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Fatigue severity- Baseline
Description
Fatigue severity scale, A self-report scale is a 9-item scale which measures the severity of fatigue. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63 (9 = best, 63 = worst)
Time Frame
Assessment will be conducted before the intervention.
Title
Fatigue severity- Post intervention
Description
Fatigue severity scale, A self-report scale is a 9-item scale which measures the severity of fatigue. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63 (9 = best, 63 = worst)
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Impact of fatigue on activities- Baseline
Description
Fatigue impact scale. The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Answers are scored on a four point scale where 0 = no problem and 4 = extreme problem. (0 = best, 160 = worst)
Time Frame
Assessment will be conducted before the intervention.
Title
Impact of fatigue on activities- Post intervention
Description
Fatigue impact scale. The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Answers are scored on a four point scale where 0 = no problem and 4 = extreme problem. (0 = best, 160 = worst)
Time Frame
Assessment will be conducted immediately after the intervention.
Title
Health related quality of life- Baseline
Description
Multiple Sclerosis Quality of Life (MSQOL)-54 scale.. There is no single overall score for the MSQOL-54. Two summary scores -physical health and mental health- can be derived from a weighted combination of scale scores. (0=worst, 100=best)
Time Frame
Assessment will be conducted before the intervention.
Title
Health related quality of life- Post intervention- Post intervention
Description
Multiple Sclerosis Quality of Life (MSQOL)-54 scale.. There is no single overall score for the MSQOL-54. Two summary scores -physical health and mental health- can be derived from a weighted combination of scale scores. (0=worst, 100=best)
Time Frame
Assessment will be conducted immediately after the intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 less than or equal to 4
Exclusion Criteria:
Any cardiovascular, orthopedic, visual, hearing, and perception problems that may affect the results of the research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kader Eldemir, PT, MSc.
Organizational Affiliation
Research Assistant
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Arzu Gรผรงlรผ-Gรผndรผz, PT, PhD
Organizational Affiliation
Professor
Official's Role
Study Director
Facility Information:
Facility Name
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/?term=Web-based+interventions+in+multiple+sclerosis%3A+the+potential+of+tele-rehabilitation
Description
related info
URL
https://pubmed.ncbi.nlm.nih.gov/29859267/
Description
related info
URL
https://pubmed.ncbi.nlm.nih.gov/30744491/
Description
related info
Learn more about this trial
The Effect of Telerehabilitation Based Pilates Training in Multiple Sclerosis Patients
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