Hybrid Rehabilitation Approach Through Group Exercise and Telerehabilitation in Patients With Multiple Sclerosis

Sponsor

Brno University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05469568

Collaborator

(none)

Enrollment

Location

Arms

29.3

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to determine the benefits of outpatient group rehabilitation with subsequent telerehabilitation. The patient will participate in a 12-week circuit training, including training once a week in a group of six under the guidance of two physiotherapists. After the outpatient rehabilitation, the patient will gain access to a mobile application and will be asked to record all physical activities there.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Circuit training followed by telerehabilitation Other: Usual care	N/A

Detailed Description

In the Czech population more than 20,000 people have been diagnosed with multiple sclerosis (MS), an autoimmune disease affecting a patient's central nervous system. This disease has a wide range of symptoms, with the most common ones being various motor disorders that negatively affect the locomotor function and patients' quality of life.

The positive effect of physical activity on human health is well known. This study aims to examine the effect of hybrid exercise program on people with MS. This exercise program includes ambulatory circuit training for twelve weeks followed by telerehabilitation. The aim of the study is to find out whether the exercise program will positively affect the movement skills of probands and improve their quality of life. Testing will done before the start of the exercise program, after twelve weeks and after 6 months. Movement skills will be tested by a set of movement tests called miniBEST test. For measuring quality of life the investigators will the SF-36 questionnaire will be used. Another goal will analyze participants' satisfaction with the intervention and adherence to regular physical activity.

The investigators anticipate that regular physical training combined with telerehabilitation will increase the motivation and effectiveness of independent training in people with MS leading to improvment of physical fitness, physical activity levels and quality of life.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Hybrid Rehabilitation Approach Through Group Exercise and Telerehabilitation in Patients With Multiple Sclerosis

Anticipated Study Start Date :

Jul 13, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Dec 20, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Circuit training and telerehabilitation The experimental group will participate in a 12-week rehabilitation program, including training once a week. After the end of this outpatient program, participants will gain access to a mobile application in which participants will record all their physical activities.The mobile application will also include a library of exercises taught during the outpatient program so patients can practice them at home.	Other: Circuit training followed by telerehabilitation Patients participate in an ambulatory rehabilitation program (12 weeks) and then gain access to mobile application to record their movement activities. This application will aslo inlude a library with exercise vidoes from the ambulatory program. These videos should inspire patients to do the exercises at home.
Sham Comparator: Usual Care Patients have usual care and usual information about importance of regular movement activities and recommendation of proper exercises. Patients don't visit ambulatory rehabilitation program and they don't have access to an application	Other: Usual care Patients have usual information about importance of regular movement activities and recommendation of proper exercises

Arm

Intervention/Treatment

Experimental: Circuit training and telerehabilitation

The experimental group will participate in a 12-week rehabilitation program, including training once a week. After the end of this outpatient program, participants will gain access to a mobile application in which participants will record all their physical activities.The mobile application will also include a library of exercises taught during the outpatient program so patients can practice them at home.

Other: Circuit training followed by telerehabilitation

Patients participate in an ambulatory rehabilitation program (12 weeks) and then gain access to mobile application to record their movement activities. This application will aslo inlude a library with exercise vidoes from the ambulatory program. These videos should inspire patients to do the exercises at home.

Sham Comparator: Usual Care

Patients have usual care and usual information about importance of regular movement activities and recommendation of proper exercises. Patients don't visit ambulatory rehabilitation program and they don't have access to an application

Other: Usual care

Patients have usual information about importance of regular movement activities and recommendation of proper exercises

Outcome Measures

Primary Outcome Measures

Change from Baseline Movement skills score at 12 weeks and 6 months [Baseline, 12 weeks, 6 months]
Mini Balance Evaluation Systems Test (Mini BESTest) - 14-item scale for measure postural stability. Maximum value is 28 points, minimum value is 0 point. Higher scores mean a better outcome.

Secondary Outcome Measures

Change from Baseline Depression score at 12 weeks and 6 months [Baseline, 12 weeks, 6 months]
Beck's Depression Inventory (BDI) - 21-item, self-report rating. Maximum value is 63 points, minimum value is 0 point. Higher scores mean a worse outcome.
Change from Baseline Walking skills score at 12 weeks and 6 months [Baseline, 12 weeks, 6 months]
12-Item Multiple Sclerosis Walking Scale - self-report rating. Maximum value is 60 points, minimum value is 12 point. Higher scores mean a worse outcome.
Exercise adherence [6 months]
Number of added movement activities in application. Higher scores mean better adherence to exercise.
Change from Baseline Health related quality of life score at 12 weeks and 6 months [Baseline, 12 weeks, 6 months]
Short Form Survey (SF-36) - 36-item. Maximum value is 100 points, minimum value is 36 point. Higher score mean a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18
Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria
Minimal one month from last relapse
Possibility to use smartphone or tablet because of using rehabilitation application

Exclusion Criteria:

Illnesses which can limiting exercises activities (e.g. orthopedic, cardiology or other neurological diseases)
Cognitive deficit which can limiting cooperation (fill a questionnaire, comply with movement task, using application)
Relapse of diseases during study