Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Telerehabilitation Based Pilates Training in Multiple Sclerosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04838886
Recruitment Status : Recruiting
First Posted : April 9, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Kader Eldemir, Gazi University

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, ıt 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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Telerehabilitation-based Pilates Exercise Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention and control groups
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Telerehabilitation Based Pilates Training on Physical Performance and Quality of Life in Multiple Sclerosis Patients
Estimated Study Start Date : April 15, 2021
Estimated Primary Completion Date : March 15, 2022
Estimated Study Completion Date : March 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise group
The intervention group will be received telerehabilitation-based pilates training three times a week for 6 weeks.
Other: Telerehabilitation-based Pilates Exercise
The group that will receive telerehabilitation-based pilates training via telerehabilitation

No Intervention: Waitlist
The control group will be a wait-list group without any additional specific treatment.



Primary Outcome Measures :
  1. Dynamic Balance- Baseline [ Time Frame: Assessment will be conducted before the 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)

  2. Dynamic Balance-Post intervention [ Time Frame: Assessment will be conducted immediately after the 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)

  3. Static Balance- Baseline [ Time Frame: Assessment will be conducted before the intervention. ]
    Biodex Balance System

  4. Static Balance- Post intervention [ Time Frame: Assessment will be conducted immediately after the intervention. ]
    Biodex Balance System

  5. An individual's confidence in performing activities- Baseline [ Time Frame: Assessment will be conducted before the intervention. ]
    Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best)

  6. An individual's confidence in performing activities- Post intervention [ Time Frame: Assessment will be conducted immediately after the intervention. ]
    Activities-specific Balance Confidence Scale. Items are rated on a 0% to 100% whole number rating scale. (0 = worst,100 = best)

  7. Exercise capacity- Baseline [ Time Frame: Assessment will be conducted before the intervention. ]
    Six minute walk test

  8. Exercise capacity- Post intervention [ Time Frame: Assessment will be conducted immediately after the intervention. ]
    Six minute walk test

  9. Gait parameters- Baseline [ Time Frame: Assessment will be conducted before the intervention. ]
    Wearable system (G-Walk)

  10. Gait parameters- Post intervention [ Time Frame: Assessment will be conducted immediately after the intervention. ]
    Wearable system (G-Walk)

  11. Functional mobility- Baseline [ Time Frame: Assessment will be conducted before the intervention. ]
    Timed up go test

  12. Functional mobility- Post intervention [ Time Frame: Assessment will be conducted immediately after the intervention. ]
    Timed up go test

  13. Core endurance- Baseline [ Time Frame: Assessment will be conducted before the intervention. ]
    Mcgill core endurance tests

  14. Core endurance- Post intervention [ Time Frame: Assessment will be conducted immediately after the intervention. ]
    Mcgill core endurance tests

  15. Core strength- Baseline [ Time Frame: Assessment will be conducted before the intervention. ]
    Mcgill core strength tests

  16. Core strength-Post intervention [ Time Frame: Assessment will be conducted immediately after the intervention. ]
    Mcgill core strength tests

  17. Muscle Strength outcomes- Baseline [ Time Frame: Assessment will be conducted before the intervention. ]
    Hand dynamometer (Baseline®, White Plains, New York, US)

  18. Muscle Strength outcomes- Post intervention [ Time Frame: Assessment will be conducted immediately after the intervention. ]
    Hand dynamometer (Baseline®, White Plains, New York, US)


Secondary Outcome Measures :
  1. Physical activity level- Baseline [ Time Frame: Assessment will be conducted before the 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)

  2. Physical activity level- Post intervention [ Time Frame: Assessment will be conducted immediately after the 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)

  3. Fatigue severity- Baseline [ Time Frame: Assessment will be conducted before the 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)

  4. Fatigue severity- Post intervention [ Time Frame: Assessment will be conducted immediately after the 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)

  5. Impact of fatigue on activities- Baseline [ Time Frame: Assessment will be conducted before the 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)

  6. Impact of fatigue on activities- Post intervention [ Time Frame: Assessment will be conducted immediately after the 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)

  7. Health related quality of life- Baseline [ Time Frame: Assessment will be conducted before the 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)

  8. Health related quality of life- Post intervention- Post intervention [ Time Frame: Assessment will be conducted immediately after the 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04838886


Contacts
Layout table for location contacts
Contact: Kader Eldemir, PT, MSc. +905447948344 fztkader2015@gmail.com

Locations
Layout table for location information
Turkey
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Recruiting
Ankara, Turkey
Contact    +095447948344    fztkader2015@gmail.com   
Sponsors and Collaborators
Gazi University
Investigators
Layout table for investigator information
Study Chair: Kader Eldemir, PT, MSc. Research Assistant
Study Director: Arzu Güçlü-Gündüz, PT, PhD Professor
Additional Information:
Layout table for additonal information
Responsible Party: Kader Eldemir, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT04838886    
Other Study ID Numbers: Gazi 2
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kader Eldemir, Gazi University:
Multiple Sclerosis
Pilates
Exercise
Telerehabilitation
Physical performance
Balance
Gait
Fatigue
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases