The Effects of Two Different Types of Exercise Programs to Increase Physical Activity in Patients With MS

June 19, 2023 updated by: Gamze Öztürk, Istanbul University - Cerrahpasa (IUC)

The Effects of a Supervised Exercise Program Versus Online Education Program to Increase Physical Activity in Patients With Multiple Sclerosis

Multiple Sclerosis (MS) is a chronic, inflammatory, neurodegenerative, autoimmune disease of the central nervous system. It is thought that MS, which is one of the main causes of non-traumatic neurological dysfunction in young adults, affects approximately two and a half million people worldwide. The annual cost caused by MS is reported to be between $ 8,528 and $ 54,244 per patient. Due to the destruction of the central nervous system, MS has a wide range of sensory, motor, cerebellar and cognitive dysfunctions. These dysfunctions may lead to a limitation of physical activity in people with MS. In addition, people with MS may limit their physical activity because they fear the worsening of their symptoms. Physical inactivity and sedentary life style are thought to be among the reasons that increase the risk of developing chronic diseases such as cancer, hypercholesterolemia, hypertension, arthritis, osteoporosis, obesity, type 2 diabetes, depression and cardiovascular diseases in people with MS. It is reported that these chronic diseases secondary to MS increase mortality by 1.7 times. In addition, these diseases have been associated with increased disability, decreased quality of life, and hospitalization. Physical inactivity can increase disability and mortality by aggravating health problems caused by the disease. For this reason, it is emphasized that there should be studies to increase physical activity in people with MS. Studies have shown that physical activity improves muscle strength, aerobic capacity, gait and balance and reduces fatigue in people with MS. In addition, it is stated that physical activity increases self-efficacy and improves positive perspective in patients with MS. When the literature is examined, it is seen that there are studies about physical activity in MS but they have methodological limitations. There are a limited number of studies on the effectiveness of the programs planned to increase the level of physical activity. The aim of our study was to investigate the effects of physical activity program and online training program on physical activity in patients with MS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

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 Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34000
        • 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

25 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being diagnosed with Multiple Sclerosis
  • Being between 25 and 60 age range
  • Not having attacks during last 3 months
  • Having ≤ 5.5 Expanded Disability Status Scale
  • Not having received physiotherapy and rehabilitation sessions for at least 3 months
  • Having internet access

Exclusion Criteria:

  • Pregnancy
  • Blurred vision
  • Use of assistive devices for ambulation
  • Having another diagnosis rather than Multiple Sclerosis

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 Program Group
Participants in the supervised exercise group were included to a program that consisted of 16 individual physiotherapist supervised sessions (two 60-minutes sessions/week), which were prepared to improve physical activity.
Other: Supervised Exercise Program
The exercise program in this group includes aerobic (walking) training and exercises to strengthen the upper and lower extremities and trunk muscles.
Experimental: Online Education Program Group
Participants in the online education group were included to a program that consisted of 16 online sessions (two 60-minutes sessions/week), which were prepared to improve physical activity.
Other: Online Education Program
The exercise program in this group includes aerobic (walking) training and home exercises to strengthen the upper and lower extremities and trunk muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Leisure-Time Exercise Questionnaire
Time Frame: 1-3 minutes
It is a self-reported leisure-time exercise questionnaire which consists of 2 parts. The first part seeks information about the number of times one engages in mild, moderate and strenuous leisure-time exercise bouts of at least 15 min duration in a typical week. The weekly frequency of mild, moderate and strenuous exercise bouts are multiplied by 3, 5, and 9 metabolic equivalents (METs) and the total score is recorded. Second part seeks information about frequency of activity which is long enough to work up sweat in a typical week.
1-3 minutes
Pedometer
Time Frame: one week
It is one of the objective methods used to evaluate physical activity. It is used to record the number of steps taken. The estimated step length is entered in the device and recorded as a step when the vertical swing of the body exceeds a certain threshold.
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Minute Walk Test
Time Frame: 6 minutes
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked on a 30 meter course over a span of 6 minutes.
6 minutes
Multiple Sclerosis Walking Scale-12
Time Frame: 3-5 minutes
It is a scale consisting of 12 questions about mobility which is used to measure walking capacity. The limitations of walking in the last two weeks are questioned. Answers are scored between 1-5 (1 = almost none, 5 = excessive). A high score indicates that the ability to walk is affected or that the patient has difficulty in walking.
3-5 minutes
Fatigue Severity Scale
Time Frame: 3-5 minutes
It is a scale that evaluates the fatigue of MS patients in daily functions. The assessment consists of 9 questions, each question is scored between 1 (strongly disagree) to 7 (strongly agree). The result score is the average value of nine questions. High score indicates increased fatigue severity
3-5 minutes
Multiple Sclerosis International Quality of Life Questionnaire
Time Frame: 5-7 minutes
The scale consists of 31 questions in 6 sub-groups including physical status, symptoms, psychological status, self-esteem, relationship with friends, family and medical staff. The answers are scored between 0 and 5 and a score between 0 and100 is obtained. The higher the score, the higher the level of quality of life.
5-7 minutes
Brief International Cognitive Assessment for MS
Time Frame: 15 minutes
The Brief International Cognitive Assessment for MS is composed of 3 parts.In these parts, data processing speed, verbal memory, and visual memory are evaluated.
15 minutes
Bioelectrical Impedance Analysis
Time Frame: 1-2 minutes
It is a method that is based on measurement of body resistance with the aid of alternative electric current. Body components are calculated by this method.
1-2 minutes
Muscle Strength Test
Time Frame: 45 minutes
The isokinetic dynamometer and handheld dynamometer are used to assess muscle strength. In this study, the isokinetic dynamometer will be used to evaluate the knee extensor and flexor concentric muscle strength and the handheld dynamometer will be used to evaluate upper extremity muscle strength including arm flexors, abductors, elbow flexors and lower extremity muscle strength including hip flexors and abductors.
45 minutes

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa (IUC)

Collaborators

Prof.Dr.Mazhar Osman Mental Health and Psychiatric Diseases Education, Research Hospital

Investigators

  • Study Director: Yonca Zenginler Yazgan, Ph.D, Istanbul University - Cerrahpasa (IUC)

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)

November 1, 2019

Primary Completion (Actual)

January 8, 2020

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

November 21, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IU-C

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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