The Effects of Two Different Types of Exercise Programs to Increase Physical Activity in Patients With MS
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Supervised Exercise Program
Online Education Program
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Rehabilitation, Physical Activity, Exercise
Eligibility Criteria
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
Sites / Locations
- Istanbul University-Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Supervised Exercise Program Group
Online Education Program Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The Leisure-Time Exercise Questionnaire
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.
Pedometer
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.
Secondary Outcome Measures
6 Minute Walk Test
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.
Multiple Sclerosis Walking Scale-12
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.
Fatigue Severity Scale
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
Multiple Sclerosis International Quality of Life Questionnaire
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.
Brief International Cognitive Assessment for MS
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.
Bioelectrical Impedance Analysis
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.
Muscle Strength Test
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.
Full Information
NCT ID
NCT04175418
First Posted
November 21, 2019
Last Updated
June 19, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Prof.Dr.Mazhar Osman Mental Health and Psychiatric Diseases Education, Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04175418
Brief Title
The Effects of Two Different Types of Exercise Programs to Increase Physical Activity in Patients With MS
Official Title
The Effects of a Supervised Exercise Program Versus Online Education Program to Increase Physical Activity in Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
January 8, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Prof.Dr.Mazhar Osman Mental Health and Psychiatric Diseases Education, Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Rehabilitation, Physical Activity, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supervised Exercise Program Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Online Education Program Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Supervised Exercise Program
Intervention Description
The exercise program in this group includes aerobic (walking) training and exercises to strengthen the upper and lower extremities and trunk muscles.
Intervention Type
Other
Intervention Name(s)
Online Education Program
Intervention Description
The exercise program in this group includes aerobic (walking) training and home exercises to strengthen the upper and lower extremities and trunk muscles.
Primary Outcome Measure Information:
Title
The Leisure-Time Exercise Questionnaire
Description
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.
Time Frame
1-3 minutes
Title
Pedometer
Description
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.
Time Frame
one week
Secondary Outcome Measure Information:
Title
6 Minute Walk Test
Description
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.
Time Frame
6 minutes
Title
Multiple Sclerosis Walking Scale-12
Description
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.
Time Frame
3-5 minutes
Title
Fatigue Severity Scale
Description
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
Time Frame
3-5 minutes
Title
Multiple Sclerosis International Quality of Life Questionnaire
Description
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.
Time Frame
5-7 minutes
Title
Brief International Cognitive Assessment for MS
Description
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.
Time Frame
15 minutes
Title
Bioelectrical Impedance Analysis
Description
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.
Time Frame
1-2 minutes
Title
Muscle Strength Test
Description
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.
Time Frame
45 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonca Zenginler Yazgan, Ph.D
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effects of Two Different Types of Exercise Programs to Increase Physical Activity in Patients With MS
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