Telerehabilitation vs Supervised Exercises in MS

Study Overview
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Brief Summary
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Multiple sclerosis (MS) is a complex neurodegenerative autoimmune disease. People with MS (PwMS) have low quality of life (QoL) and activities of daily living (ADL). Exercise is a safe and effective rehabilitation tool for PwMS. A structured and personalized exercise program can improve physical fitness, functional capacity, quality of life and modifiable disorders in PwMS. On the other hand, Telerehabilitation is an alternative rehabilitation method in PwMS. The purpose of this study is to investigate the effectiveness of exercise programs and telerehabilitation on ADL and QoL in PwMS, and compare the effects of supervised exercise and home-based exercise programs for the PwMS.

Detailed Description
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Participants are randomly assigned to the structured supervised exercise or structured home-based groups. Interventions in Group 1 (n=15) includes one session per day, 3 days a week over a 12-weeks structured exercise program under the supervision of a physical therapist. Group 2 (n=15) includes a 12-week structured home-based exercise program checked and controlled through telerehabilitation three times a week. All measurements pre-post intervention.

Official Title
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Effectiveness of Structured Exercise Program on Quality of Life and Activities of Daily Living in Persons With Multiple Sclerosis: Telerehabilitation vs Supervised Program

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Structured Supervised Exercise
* Behavioral: Structured telerehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with: Stable period at the time of application to the clinic Expanded Disability Status Scale Levels between 2 - 6.5 Appropriate cognitive level to understand the exercises No diseases to affect their participation in exercise programs Exclusion Criteria: patients with: Poorly controlled diabetes, hypertension or other medical conditions to be incompatible with study participation, A new history of previous attacks No reliable informed consent

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised Exercise Group<br>One session per day, 3 days per week over a 12-weeks structured exercise program under supervision of a physical therapist. | Behavioral: Structured Supervised Exercise<br>* Structured Exercise Program under the supervision of Physical Therapist<br>|
| Experimental: Telerehabilitation Group<br>One session per day, 3 days per week over a 12-weeks structured exercise program through Telerehabilitation | Behavioral: Structured telerehabilitation<br>* Structured Exercise Program checked and controlled through telerehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure (FIM) | FIM is a tool used for evaluation of primary ADL of people with disability. FIM items include self care, sphincter control, transfers, locomotion, communication, and social cognition subgroups. Grading is based on 7 points. 7: complete independence, 6: modified independence, 5, 4 and 3: modified dependence, 2 and 1: complete dependence. | Changes after 12 weeks | 
| Nottingham Health Profile, First section (NHP-I) | NHP is a tool used for measuring and definition of QoL regarding the health status in general. NHP-I contains 38 yes/no statements, focusing on different aspects of the general health problems, including six dimensions of subjective health defined as physical abilities, pain, sleep, energy, emotional reaction, energy level and social isolation. Questions are evaluated according to the patients' yes/no responses and are scored between 0 and 100. High scores indicate high level health status in the specified item. Total scores are summed in all fields. | Changes after 12 weeks | 
| Quality of life scale (QoLS) | QoLS is a standardized interview consisting of 41 questions clustered in four subscales: functional and economic scale, social and recreational scale, affect and life in general scale, and medical problems scale. Each question in the scale is evaluated over 5 points. (1 is negative at all times and 5 is the best response). | Changes after 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Telerehabilitation, Supervised exercises, Structured exercise, Quality of Life, Activities of Daily Living