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Clinical Trials/NCT04175418
NCT04175418
Completed
Not Applicable

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

Istanbul University - Cerrahpasa (IUC)1 site in 1 country21 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
21
Locations
1
Primary Endpoint
The Leisure-Time Exercise Questionnaire
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
February 1, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Gamze Öztürk

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

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

Outcomes

Primary Outcomes

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.

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

  • Fatigue Severity Scale(3-5 minutes)
  • Bioelectrical Impedance Analysis(1-2 minutes)
  • Muscle Strength Test(45 minutes)
  • Multiple Sclerosis Walking Scale-12(3-5 minutes)
  • Multiple Sclerosis International Quality of Life Questionnaire(5-7 minutes)
  • Brief International Cognitive Assessment for MS(15 minutes)
  • 6 Minute Walk Test(6 minutes)

Study Sites (1)

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