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Completed

NCT Number: NCT04175418

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supervised exercise program

Other

The exercise program in this group includes aerobic (walking) training and exercises to strengthen the upper and lower extremities and trunk muscles.

online education program

Other

The exercise program in this group includes aerobic (walking) training and home exercises to strengthen the upper and lower extremities and trunk muscles.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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. 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

  4. 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. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Nov 25, 2019
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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