search
Back to results

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

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Circuit training followed by telerehabilitation
Usual care
Sponsored by
Brno University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Telerehabilitation, Circuit Training, Movement Skills, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Michaela SládečkováRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Circuit training and telerehabilitation

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Exercise adherence
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
Short Form Survey (SF-36) - 36-item. Maximum value is 100 points, minimum value is 36 point. Higher score mean a better outcome.

Full Information

First Posted
June 23, 2022
Last Updated
November 1, 2022
Sponsor
Brno University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05469568
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brno University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Telerehabilitation, Circuit Training, Movement Skills, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Circuit training and telerehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Circuit training followed by telerehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Patients have usual information about importance of regular movement activities and recommendation of proper exercises
Primary Outcome Measure Information:
Title
Change from Baseline Movement skills score at 12 weeks and 6 months
Description
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.
Time Frame
Baseline, 12 weeks, 6 months
Secondary Outcome Measure Information:
Title
Change from Baseline Depression score at 12 weeks and 6 months
Description
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.
Time Frame
Baseline, 12 weeks, 6 months
Title
Change from Baseline Walking skills score at 12 weeks and 6 months
Description
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.
Time Frame
Baseline, 12 weeks, 6 months
Title
Exercise adherence
Description
Number of added movement activities in application. Higher scores mean better adherence to exercise.
Time Frame
6 months
Title
Change from Baseline Health related quality of life score at 12 weeks and 6 months
Description
Short Form Survey (SF-36) - 36-item. Maximum value is 100 points, minimum value is 36 point. Higher score mean a better outcome.
Time Frame
Baseline, 12 weeks, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michaela Sládečková, PT
Phone
00420532236337
Email
sladeckova.michaela@fnbrno.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Michaela Sládečková
Phone
00420532236337
Email
sladeckova.michaela@fnbrno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ladislav Batalik
Organizational Affiliation
Department of Rehabilitation, University Hospital Brno, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michaela Sládečková
City
Brno
State/Province
Czech Republic
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaela Sladečková
Phone
+420532233123
Email
sladeckova.michaela@fnbrno.cz

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs