Multiple SclerosisNCT05469568
Hybrid Rehabilitation Approach Through Group Exercise and Telerehabilitation in Patients With Multiple Sclerosis
A study testing Circuit training followed by telerehabilitation in people with Multiple Sclerosis, run by Brno University Hospital at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Circuit training followed by telerehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Jul 2022to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Circuit training followed by telerehabilitation, Usual care
- Keywords
- Multiple Sclerosis, Telerehabilitation, Circuit Training, Movement Skills, Quality of Life
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circuit training followed by telerehabilitationOther
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 careOther
Patients have usual information about importance of regular movement activities and recommendation of proper exercises
| Study group | Role | What they receive |
|---|---|---|
| Circuit training and telerehabilitation | Experimental | 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. Receives: Other: Circuit training followed by telerehabilitation |
| Usual Care | Sham comparator | 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 Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Movement skills score at 12 weeks and 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.
Measured: Baseline, 12 weeks, 6 months
Secondary outcomes (4)
Change from Baseline Depression score at 12 weeks and 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.
Measured: Baseline, 12 weeks, 6 months
Change from Baseline Walking skills score at 12 weeks and 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.
Measured: Baseline, 12 weeks, 6 months
Exercise adherence
Number of added movement activities in application. Higher scores mean better adherence to exercise.
Measured: 6 months
Change from Baseline Health related quality of life score at 12 weeks and 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.
Measured: Baseline, 12 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start15 Jul 2022
- Primary completion26 Sep 2025
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ladislav Batalik, Brno University Hospital
- Investigators
- Ladislav Batalik, Principal investigator, Department of Rehabilitation, University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05469568
- Sponsor's protocol ID
- Hybrid rehabilitation approach
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2022
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Rehabilitation Approach Through Group Exercise and Telerehabilitation in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05469568
- Acronym / sponsor ID
- Hybrid rehabilitation approach
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Telerehabilitation, Circuit Training, Movement Skills, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circuit training and telerehabilitation | Experimental | Other: Circuit training followed by telerehabilitationThe 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. |
| Usual Care | Sham comparator | Other: Usual carePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circuit training followed by telerehabilitationPatients 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. | Other | Circuit training and telerehabilitation |
| Usual carePatients have usual information about importance of regular movement activities and recommendation of proper exercises | Other | Usual Care |
Primary outcome
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.
4 secondary outcomes
Change from Baseline Depression score at 12 weeks and 6 months
Time frame: Baseline, 12 weeks, 6 months
Change from Baseline Walking skills score at 12 weeks and 6 months
Time frame: Baseline, 12 weeks, 6 months
Exercise adherence
Time frame: 6 months
Change from Baseline Health related quality of life score at 12 weeks and 6 months
Time frame: Baseline, 12 weeks, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ladislav Batalik principal investigator
Department of Rehabilitation, University Hospital Brno, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circuit training followed by telerehabilitation in people with Multiple Sclerosis, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Movement skills score at 12 weeks and 6 months (time frame: Baseline, 12 weeks, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.