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

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Other: Usual care; Other: Circuit training followed by telerehabilitation

• Registration Number: NCT05469568
• Lead Sponsor: Brno University Hospital

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.

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 Timeline

• Study First Submitted: 2022-06-23
• Study Start: 2022-07-15
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	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
Circuit training and telerehabilitation	Circuit training followed by 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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 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.
Exercise adherence	6 months	Number of added movement activities in application. Higher scores mean better adherence to exercise.

Trial Locations

Locations (1)

Michaela Sládečková; 🇨🇿 Brno, Czech Republic, Czechia