The Effect of Hybrid Telerehabilitation-Based Structured Exercise Programs in Patients With Multiple Sclerosis

NCT ID: NCT06293079

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2024-09-30

Brief Summary

The aim of our study is to compare the effects of hybrid telerehabilitation (TR)-based exercise program applied in patients with MS, only TR-based exercise program and only clinical-based exercise program on walking speed, functional capacity, peripheral muscle saturation and fatigue. Forty-five individuals with MS with EDSS scores between 0-4 will be included in the study. The patients will be randomized into three groups: Group A, Group B, and Group C. Group A- Telerehabilitation group will be included in an aerobic and strengthening exercise program over the synchronized videoconference system with the physiotherapist 2 days a week for 8 weeks. Group B- Hybrid Telerehabilitation group will be included in the same exercise program 2 days a week for 2 weeks in the clinic, and will continue remotely over the synchronized videoconference system with the physiotherapist 2 days a week for 6 weeks. In Group C-Clinical Based Rehabilitation group, the same exercise program will be applied in the clinic 2 days a week for 8 weeks. In addition to aerobic and strengthening exercises, traditional breathing exercises and energy conservation techniques will be taught to all three groups within the scope of patient education Demographic and clinical information of all patients to be included in the study will be recorded with a "Case Evaluation Form". The gait speed of the patients will be evaluated with the Timed 25-step walking test, their functional capacity with the 6-minute walking test, their Quadriceps muscle activation will be tested with the EMG muscle activation, the fatigue will be evaluated with the "Modified Fatigue Impact Scale", and the Patient Satisfaction with the "Global Rating Scale". In addition, feasibility evaluation will be made by calculating the attendance rate of the patients to the programs. All data will be evaluated by statistical analysis methods.

Detailed Description

Multiple Sclerosis (MS) is a chronic progressive disease that often leads to deterioration of health-related quality of life, including symptoms such as muscle weakness, extreme fatigue, gait disturbances, sensory problems, balance problems, and chronic pain, cognitive and motor impairments. Physiotherapy and rehabilitation programs that include aerobic and progressive resistance exercises in the treatment of functional disorders by controlling the symptoms of the disease increase the quality of life by improving aerobic capacity, but sustainability can be difficult due to difficulties in accessing the clinic. Following exercise programs with telerehabilitation (TR) methods improves cognitive function, mobility, balance, participation, and quality of life by increasing physical activity and reducing fatigue. However, the details of the frequency, duration, and the way the program is delivered are not known, and although the exercise methods applied with TR methods are found to be as effective as the practices performed in the clinic, the remote limited patient-therapist relationship creates potential problems for patients to follow up on the digital platform. The hybrid TR model, in which a certain part of the exercise program is carried out face-to-face, can provide a solution to these problems by increasing patient-therapist communication. To the best of our knowledge, there is no study examining the effectiveness of a rehabilitation program applied with the hybrid TR model for individuals with MS. The aim of our study is to compare the effects of hybrid telerehabilitation (TR)-based exercise program applied in patients with MS, only TR-based exercise program and only clinical-based exercise program on walking speed, functional capacity, peripheral muscle saturation and fatigue. Forty-five individuals with MS with EDSS scores between 0-4 will be included in the study. The patients will be randomized into three groups: Group A, Group B, and Group C. Group A- Telerehabilitation group will be included in an aerobic and strengthening exercise program over the synchronized videoconference system with the physiotherapist 2 days a week for 8 weeks. Group B- Hybrid Telerehabilitation group will be included in the same exercise program 2 days a week for 2 weeks in the clinic, and will continue remotely over the synchronized videoconference system with the physiotherapist 2 days a week for 6 weeks. In Group C-Clinical Based Rehabilitation group, the same exercise program will be applied in the clinic 2 days a week for 8 weeks. In addition to aerobic and strengthening exercises, traditional breathing exercises and energy conservation techniques will be taught to all three groups within the scope of patient education Demographic and clinical information of all patients to be included in the study will be recorded with a "Case Evaluation Form". The gait speed of the patients will be evaluated with the Timed 25-step walking test, their functional capacity with the 6-minute walking test, their Quadriceps muscle activation will be tested with the EMG muscle activation, the fatigue will be evaluated with the "Modified Fatigue Impact Scale", and the Patient Satisfaction with the "Global Rating Scale". In addition, feasibility evaluation will be made by calculating the attendance rate of the patients to the programs. All data will be evaluated by statistical analysis methods. The aim of this study is to investigate the effect of hybrid telerehabilitation program on walking speed, functional capacity, peripheral muscle activation and fatigue in patients with MS.

For these purposes:

• To increase compliance and participation of MS patients in exercises,
• To prevent fatigue by increasing the functional capacity of MS patients who regularly participate in exercise programs,
• To provide a sustainable program for exercise continuity for MS patients who have difficulty reaching the clinic and to examine its effects on fatigue,
• To compare the effects of Telerehabilitation, Hybrid Telerehabilitation and the same exercise programs performed in the clinic on gait speed, functional capacity, peripheral muscle activation and fatigue,
• To examine the statistical differences and relationships between the expected improvements in functional capacity, peripheral muscle activation and fatigue parameters,
• To offer an innovative and effective treatment option to clinicians and experts working in the relevant field with the hybrid telerehabilitation model, which can be an alternative to traditional methods,
• It is aimed to contribute to the literature in this field by transforming the results obtained because of the study into qualified scientific publications.

Conditions

Multiple Sclerosis

Keywords

telerehabilitation; exercise therapy; MS patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Telerehabilitation Group

An eight-week rehabilitation program will be implemented synchronously with the physiotherapist two days a week via video conferencing system.

Group Type: ACTIVE_COMPARATOR

Exercise Program

Intervention Type: OTHER

Structured rehabilitation program of the groups; Patient education consists of aerobic and strengthening exercises. An information brochure will be given to patients after the first evaluation about the program to be implemented.

Hybrid Telerehabilitation Group

The first two weeks of the eight-week program will be applied face to face in the clinic, and the six weeks will be applied synchronously with the physiotherapist via video conferencing system.

Group Type: EXPERIMENTAL

Exercise Program

Intervention Type: OTHER

Structured rehabilitation program of the groups; Patient education consists of aerobic and strengthening exercises. An information brochure will be given to patients after the first evaluation about the program to be implemented.

Clinic Group

An eight-week rehabilitation program will be implemented face to face in the clinic.

Group Type: ACTIVE_COMPARATOR

Exercise Program

Intervention Type: OTHER

Structured rehabilitation program of the groups; Patient education consists of aerobic and strengthening exercises. An information brochure will be given to patients after the first evaluation about the program to be implemented.

Interventions

Exercise Program

Structured rehabilitation program of the groups; Patient education consists of aerobic and strengthening exercises. An information brochure will be given to patients after the first evaluation about the program to be implemented.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• EDSS score of 0 - 4.0
• Having high-speed internet access via smartphone or computer
• Getting at least 24 points from the Mini Mental Test
• Being at Stage 3 or above according to the Functional Ambulation Scale.

Exclusion Criteria

• Having hearing or vision problems.
• Participating in any exercise program.
• Having other accompanying neurological, cardiovascular or orthopedic disorders
• A history of MS attacks or a change in medication in the last 6 months.
• Being in a physical condition that cannot do the exercises.
• Comorbid conditions that negatively affect oxygen transport (severe anemia, peripheral artery diseases, etc.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biruni University

OTHER

Sponsor Role: lead

Responsible Party

Guzin Kaya Aytutuldu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guzin Kaya Aytutuldu

Role: PRINCIPAL_INVESTIGATOR

Biruni University

Locations

Biruni University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

PMID: 33940247 (View on PubMed)

Kjolhede T, Vissing K, Langeskov-Christensen D, Stenager E, Petersen T, Dalgas U. Relationship between muscle strength parameters and functional capacity in persons with mild to moderate degree multiple sclerosis. Mult Scler Relat Disord. 2015 Mar;4(2):151-8. doi: 10.1016/j.msard.2015.01.002. Epub 2015 Jan 12.

Reference Type: BACKGROUND

PMID: 25787191 (View on PubMed)

Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.

Reference Type: BACKGROUND

PMID: 23669008 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 30683707 (View on PubMed)

Morris ME, Cantwell C, Vowels L, Dodd K. Changes in gait and fatigue from morning to afternoon in people with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2002 Mar;72(3):361-5. doi: 10.1136/jnnp.72.3.361.

Reference Type: BACKGROUND

PMID: 11861697 (View on PubMed)

Kos D, Kerckhofs E, Nagels G, D'hooghe MB, Ilsbroukx S. Origin of fatigue in multiple sclerosis: review of the literature. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):91-100. doi: 10.1177/1545968306298934. Epub 2007 Apr 4.

Reference Type: BACKGROUND

PMID: 17409388 (View on PubMed)

Rottoli M, La Gioia S, Frigeni B, Barcella V. Pathophysiology, assessment and management of multiple sclerosis fatigue: an update. Expert Rev Neurother. 2017 Apr;17(4):373-379. doi: 10.1080/14737175.2017.1247695. Epub 2016 Oct 21.

Reference Type: BACKGROUND

PMID: 27728987 (View on PubMed)

Tollar J, Nagy F, Toth BE, Torok K, Szita K, Csutoras B, Moizs M, Hortobagyi T. Exercise Effects on Multiple Sclerosis Quality of Life and Clinical-Motor Symptoms. Med Sci Sports Exerc. 2020 May;52(5):1007-1014. doi: 10.1249/MSS.0000000000002228.

Reference Type: RESULT

PMID: 31876670 (View on PubMed)

Other Identifiers

Researcher

Identifier Type: OTHER

Identifier Source: secondary_id

BiruniUnive

Identifier Type: -

Identifier Source: org_study_id