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Active, Not Recruiting

NCT Number: NCT05469568

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michaela Sládečková

Brno, Czech Republic, 625 00, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Circuit training followed by telerehabilitation

Other

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.

Usual Care

Other

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

Primary outcomes

  1. Change from Baseline Movement skills score at 12 weeks and 6 months

    Time frame: 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 outcomes

  1. Change from Baseline Depression score at 12 weeks and 6 months

    Time frame: 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.

  2. Change from Baseline Walking skills score at 12 weeks and 6 months

    Time frame: 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.

  3. Exercise adherence

    Time frame: 6 months

    Number of added movement activities in application. Higher scores mean better adherence to exercise.

  4. Change from Baseline Health related quality of life score at 12 weeks and 6 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 21, 2022
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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