The Effects of Internet-Based and Supervised Exercise Programs in People With Multiple Sclerosis

NCT06210581 | Unknown

• 1 other identifier: IUC2023-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is resarch and compare the effects of supervised exercise programs and internet-based exercise programs, which have started to benefit from their effects in recent years, known for not requiring conditions such as transportation distance, cost and time, on motor disorders and quality of life in people with multiple sclerosis (MS). This study conducting for develop a new perspective on conventional physiotherapy and rehabilitation practices. Our study will be performed in people with MS with a high EDSS score, is seen as an important contribution for the literature.

Conditions

Multiple Sclerosis

Keywords

Balance; Multiple Sclerosis; Exercise

Outcome Measures

Primary Outcomes (1)

• 2 Minutes Walk Test (2MWT) (The change between the initial value and the value after 2 months will be evaluated).

  This test is performed for the assessment of walking endurance. The patient is informed about the test before starting the test. The distance that a person walks along a 25-meter corridor in 2 minutes is calculated in meters. During the test, patients who have tiredness and shortness of breath can have a rest.

  Baseline and end of weeks 8.

Secondary Outcomes (10)

• Fatigue Severity Scale (FSS) (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

• 12 Item MS Walking Scale (MSWS- 12) (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

• Modified Falls Efficacy Scale (MFES) (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

• Canadian Occupational Performance Measure (COPM) (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

• Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) (The change between the initial value and the value after 2 months will be evaluated).

  Baseline and end of weeks 8.

Study Arms (2)

Group I

EXPERIMENTAL

The treatment sessions will be terminated by performing relaxation exercises combined with stretching and breathing exercises.

Other: Supervised Exercise Program Group

Group II

OTHER

Patients who are in the internet-based exercise program group will register cite ''https://www.telenororehab.com /'' which is web- based physiotherapy program for exercises.

Other: Internet Based Exercise Program Group

Interventions

Supervised Exercise Program Group OTHER

The exercise programs will performed with the physiotherapist. The treatment programs of the patients will start with warm-up exercises and continue with aerobic exercises. Strengthening exercises will be performed in lying, sitting and standing positions. Body weight or free weight will be used for strengthening exercises. Balance exercises will be performed in sitting and standing positions and will be performed with or without support according to the patients conditions. The treatment sessions will be terminated by performing relaxation exercises combined with stretching and breathing exercises.

Group I

Internet Based Exercise Program Group OTHER

Patients who are in the internet-based exercise program group will register cite ''https://www.telenororehab.com /'' which is web- based physiotherapy program for exercises. After the first evaluation patients will be given a username and password to log in to the system. Before starting the exercise programs, the pages on how patients can log in to the system, how they can reach the physiotherapist through the system and how they can find individual exercise programs will be shown before the study. After logging in to their own pages, patients will be able to access video-based exercise programs that have been specially prepared for them. Patients in the Internet-based exercise program group will also be given the same exercise programs as the supervised exercise program group. The entry-exit times of patients to the system and the duration of maintaining exercise programs will be controlled from the administrator section on the system.

Group II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with MS by a neurologist
• Being between ages of 18-65
• Not having had an attack in the last 3 months
• The score of Expanded Disability Status Scale (EDSS) is 5.5- 7.5
• Not participating in a another physiotherapy and rehabilitation program
• Having internet access

You may not qualify if:

• Pregnancy
• Severe cognitive impairment that effects participating to rehabilitation
• The cardiopulmonary disease that will prevent aerobic exercise
• Having a major hearing and/or vision problem
• Having a major speech disorder

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, 34100, Turkey (Türkiye)

RECRUITING

Related Links

• Article
• Article
• Article
• Article
• Article

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Yonca ZENGINLER YAZGAN

  Istanbul University-Cerrahpasa Faculty of Health Science

  STUDY CHAIR

• Murat KURTUNCU

  Istanbul University Faculty of Medicine Department of Neurology

  STUDY CHAIR

Central Study Contacts

Tahire Başak DEMIR

CONTACT

+90 539 484 85 42; tahirebasak.demir@ogr.iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: May 29, 2023
• Primary Completion: May 29, 2024
• Study Completion: October 29, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)