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

NCT04175418 | Completed

• 1 other identifier: IU-C
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Rehabilitation; Physical Activity; Exercise

Outcome Measures

Primary Outcomes (2)

• 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.

  1-3 minutes

• 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.

  one week

Secondary Outcomes (7)

• 6 Minute Walk Test

  6 minutes

• Multiple Sclerosis Walking Scale-12

  3-5 minutes

• Fatigue Severity Scale

  3-5 minutes

• Multiple Sclerosis International Quality of Life Questionnaire

  5-7 minutes

• Brief International Cognitive Assessment for MS

  15 minutes

Study Arms (2)

Supervised Exercise Program Group

EXPERIMENTAL

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

Online Education Program Group

EXPERIMENTAL

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

Interventions

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.

Supervised Exercise Program Group

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.

Online Education Program Group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Prof.Dr.Mazhar Osman Mental Health and Psychiatric Diseases Education, Research Hospital: collaborator

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Yonca Zenginler Yazgan, Ph.D

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 25, 2019
• Study Start: November 1, 2019
• Primary Completion: January 8, 2020
• Study Completion: February 1, 2021
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

TU (1)