Clinical trial NCT05469568: Hybrid Rehabilitation Approach Through Group Exercise and Telerehabilitation in Patients With Multiple Sclerosis
Official title: Hybrid Rehabilitation Approach Through Group Exercise and Telerehabilitation in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Telerehabilitation
Circuit Training
Movement Skills
Quality of Life
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Movement skills score at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks, 6 months
Secondary outcomes:
measure: Change from Baseline Depression score at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks, 6 months
measure: Change from Baseline Walking skills score at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks, 6 months
measure: Exercise adherence
timeFrame: 6 months
measure: Change from Baseline Health related quality of life score at 12 weeks and 6 months
timeFrame: Baseline, 12 weeks, 6 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Michaela Sládečková
state: Czech Republic
Study officials:
affiliation: Department of Rehabilitation, University Hospital Brno, Czech Republic
name: Ladislav Batalik
role: PRINCIPAL_INVESTIGATOR
References: