The Effects of a Supervised Exercise Program Versus Online Education Program to Increase Physical Activity in Patients With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Pedometer
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Supervised Exercise Program (Other)
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.
Intervention: Online Education Program (Other)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- 6 Minute Walk Test(6 minutes)
- 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)
Investigators
Gamze Öztürk
Principal Investigator
Istanbul University - Cerrahpasa (IUC)