Telerehabilitation vs Supervised Exercises in MS

May 30, 2020 updated by: Ela Tarakci, Istanbul University

Effectiveness of Structured Exercise Program on Quality of Life and Activities of Daily Living in Persons With Multiple Sclerosis: Telerehabilitation vs Supervised Program

Multiple sclerosis (MS) is a complex neurodegenerative autoimmune disease. People with MS (PwMS) have low quality of life (QoL) and activities of daily living (ADL). Exercise is a safe and effective rehabilitation tool for PwMS. A structured and personalized exercise program can improve physical fitness, functional capacity, quality of life and modifiable disorders in PwMS. On the other hand, Telerehabilitation is an alternative rehabilitation method in PwMS. The purpose of this study is to investigate the effectiveness of exercise programs and telerehabilitation on ADL and QoL in PwMS, and compare the effects of supervised exercise and home-based exercise programs for the PwMS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants are randomly assigned to the structured supervised exercise or structured home-based groups. Interventions in Group 1 (n=15) includes one session per day, 3 days a week over a 12-weeks structured exercise program under the supervision of a physical therapist. Group 2 (n=15) includes a 12-week structured home-based exercise program checked and controlled through telerehabilitation three times a week. All measurements pre-post intervention.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34815
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

patients with:

  1. Stable period at the time of application to the clinic
  2. Expanded Disability Status Scale Levels between 2 - 6.5
  3. Appropriate cognitive level to understand the exercises
  4. No diseases to affect their participation in exercise programs

Exclusion Criteria:

patients with:

  1. Poorly controlled diabetes, hypertension or other medical conditions to be incompatible with study participation,
  2. A new history of previous attacks
  3. No reliable informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supervised Exercise Group
One session per day, 3 days per week over a 12-weeks structured exercise program under supervision of a physical therapist.
Behavioral: Structured Supervised Exercise
Structured Exercise Program under the supervision of Physical Therapist
Experimental: Telerehabilitation Group
One session per day, 3 days per week over a 12-weeks structured exercise program through Telerehabilitation
Behavioral: Structured telerehabilitation
Structured Exercise Program checked and controlled through telerehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Independence Measure (FIM)
Time Frame: Changes after 12 weeks
FIM is a tool used for evaluation of primary ADL of people with disability. FIM items include self care, sphincter control, transfers, locomotion, communication, and social cognition subgroups. Grading is based on 7 points. 7: complete independence, 6: modified independence, 5, 4 and 3: modified dependence, 2 and 1: complete dependence.
Changes after 12 weeks
Nottingham Health Profile, First section (NHP-I)
Time Frame: Changes after 12 weeks
NHP is a tool used for measuring and definition of QoL regarding the health status in general. NHP-I contains 38 yes/no statements, focusing on different aspects of the general health problems, including six dimensions of subjective health defined as physical abilities, pain, sleep, energy, emotional reaction, energy level and social isolation. Questions are evaluated according to the patients' yes/no responses and are scored between 0 and 100. High scores indicate high level health status in the specified item. Total scores are summed in all fields.
Changes after 12 weeks
Quality of life scale (QoLS)
Time Frame: Changes after 12 weeks
QoLS is a standardized interview consisting of 41 questions clustered in four subscales: functional and economic scale, social and recreational scale, affect and life in general scale, and medical problems scale. Each question in the scale is evaluated over 5 points. (1 is negative at all times and 5 is the best response).
Changes after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Collaborators

Medipol University
Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Ela Tarakci, Professor, etarakci@istanbul.edu.tr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

February 10, 2020

Study Completion (Actual)

May 30, 2020

Study Registration Dates

First Submitted

May 30, 2020

First Submitted That Met QC Criteria

May 30, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

May 30, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-TeleRehab2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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