To Investigate the Effect of Aerobic Exercise on Neurophysiological Values and Functionality in Individuals With Multiple Sclerosis.

October 9, 2019 updated by: Furkan BİLEK, Firat University

Multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system, is characterized by myelin, oligodendrocytes and axon damage.

Physical exercises can be beneficial to patients, reduce fatigue and improve their strength, endurance and quality of life. Exercise has the potential to improve and / or preserve functionality, aerobic condition, strength, fatigue, health-related quality of life, depression, and cognition in MS patients. It has been reported that aerobic exercise increases muscle strength and endurance in peak oxygen intake and decreases fatigue and improves activity level, balance and walking patterns.

It is important to control the problems caused by ataxia in MS patients, to improve balance and postural reactions and to increase proximal muscle and trunk stabilization. For this purpose, movements are voluntarily and graded. Progress in exercises is achieved by making changes in the speed, width and complexity of movement. However, Frenkel Coordination exercises for extremity ataxia are usually included in the physiotherapy and rehabilitation program.

Little is known about the role and function of the iris in the nervous system with the discovery of Irisin and its precursor protein FNDC5. Evidence that the plasma level of iris increases during physical exercise suggests that it may also have beneficial and neuroprotective effects in the brain. Increased physical exercise has been shown to be associated with FNDC5 expression and ultimately more secretion of the iris.

The effect of elevated plasma iris levels after aerobic exercise on functionality in MS patients is unknown. Moon et al. Observed that cellular proliferation in mouse hippocampus cells was dose-dependent due to iris. In spraque dawley-type male rats, the presence of significant iris in the myelin sheath of the skeletal muscle shows that this tissue is an important source of iris. Based on these findings, it is thought that exercise-induced iris, which is an important cause of disability in MS, may have beneficial effects on the recovery of normal function in these patients. Whether iris affects nerve conduction velocity will be determined by electromyography analysis before and after aerobic exercise. In addition, the relationship between aerobic exercise and motor and sensory function and iris will be investigated and evaluated with functional tests.

Study Overview

Detailed Description

Purpose of the research:

The aim of this study is to investigate the effect of aerobic exercise on neurophysiological values and functionality in individuals with multiple sclerosis.

The aim of this study is to determine whether aerobic exercise has positive effects on neurophysiological values and functionality in MS patients and to investigate this in a multidisciplinary and multidisciplinary manner.

Materials and Methods:

Patients with MS who were referred to the physiotherapy and rehabilitation program by the Physical Medicine and Rehabilitation specialist at Fırat University Training and Research Hospital will be included in the study.

In this study, patients with MS will be divided into two groups by stratified randomization method. Stratification will be performed in the early period of MS (EDSS 0.5-2.5) and in the late period of MS (EDSS 3-5.5). For a total of 18 sessions, only Frenkel Coordination exercises will be done to the control group, and Frenkel Coordination exercises and aerobic exercise will be applied to the study group.

Physiotherapy and Rehabilitation Program Control Group: Patients will receive Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) for 6 weeks. There will be a 1 minute break between each exercise set.

Study Group: Patients will receive Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) for 6 weeks. There will be a 1 minute break between each exercise set. Following this, an aerobic exercise of 30 minutes will be performed on the bicycle ergometer with electronic brake. Subjects will be advised not to do any exercise two days before or on that day and to eat only a light meal at least two hours before the test. The intensity of the exercise will be adjusted based on maximum oxygen consumption (VO2 max) specific to each individual.

Each exercise session;

  • 5 min warm-up = 30% of VO2 max
  • 20 min exercise = 50-60% of VO2 max
  • 5 minutes cooling in the form. The goal of aerobic exercise is to increase physical capacity, which is represented by maximum oxygen uptake (VO2max) and mechanical power generated during exercise. Training programs should be conducted at least 2 to 3 times per week (60-80% maximum work rate or 60% VO2max) for 30 to 60 minutes at moderate concentrations. These programs are effective in increasing aerobic capacity and power output in MS (16).

Oxygen consumption (VO2), exhaled carbon dioxide (VCO2), minute ventilation (VE), respiratory rate (RR), respiration change rate (RER) and oxygen saturation (SaO2) will be recorded.

Evaluation Protocol:

Electromyography (EMG), max VO2 values and iris levels are analyzed before and after treatment and scales and questionnaires will be applied to evaluate the functional levels.

Within the scope of EMG evaluation, motor and sensory conduction studies of ulnar and median nerve in upper extremity, peroneal and tibial nerve in lower extremity, F response and H-reflex study in motor nerves, sensory conduction study of sural nerve in lower extremity are planned. H reflex is a monosynaptic reflection carried by 1a sensory fibers that synapse with alpha motor neuron. Response F shows the repeated discharges of alpha motor neurons and is a test used for the evaluation of diseases that cause transmission slowdown.

The VO2 max measurement will be performed using the incremental exercise test to determine the maximum aerobic capacity. After resting for 5 minutes (sitting on the ergometer), patients will be asked to start cycling on the ergometer starting at 25W. The load will be increased by 25W every 3 minutes until depletion. Subjects will be encouraged to continue the exercise as much as possible orally. Oxygen consumption (VO2), exhaled carbon dioxide (VCO2), minute ventilation (VE), respiration rate (RR), respiration change rate (RER), oxygen saturation (SaO2) and heart rate will be recorded. In the statistical analysis, only VO2 max values will be examined.

For the analysis of the level of iris, blood samples will be taken from gel biochemistry tubes as appropriate for the analyzes to be performed from the patients at the end of the aerobic capacity assessment. Blood samples will be separated by centrifugation at 3000rpm for 10min and the obtained sera will be placed in small portions in ependorf tubes and stored at -80 ° C until analysis. Irisin levels will be studied using commercial ELISA (enzyme-linked immunosorbent assay) kits in accordance with the kit user manual.

Multiple Sclerosis Functional Composite (MSFC), Ataxia Assessment and Rating Scale (SARA), Modified Borg Scale (MBS) to determine the effect of aerobic exercise on functionality in individuals with MS , Fatigue Impact Scale (FIS), Leeds Multiple Sclerosis Quality of Life Scale (Leeds Multiple Sclerosis Quality of L)

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • EDSS score in the range of 0.5-5.5,
  • Patients with relapsing-remitting type MS
  • Patients diagnosed with MS who did not receive steroid therapy or were discontinued 3 months before starting the study.

Exclusion Criteria:

  • Has an acute MS attack or has a history of attacks in the last 3 months,
  • Have orthopedic or systemic problems to prevent participation in the exercises,
  • Another known neuromuscular disorder other than MS,
  • Immunomodulatory therapy started in the last 6 months,
  • Have visual involvement or diplopia,
  • Upper spasticity of lower limbs (Ashworth score 3 or 4),
  • Patients with cardio-pulmonary problems that would prevent their participation in the exercise.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic exercise+Frenkel coordination Study group
Patients will be given Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) 3 times a week for 6 weeks. There will be a 1 minute break between each exercise set. Following this, an aerobic exercise of 30 minutes will be performed on the bicycle ergometer with electronic brake. Subjects will be advised not to do any exercise two days before or on that day and to eat only a light meal at least two hours before the test. The intensity of the exercise will be adjusted based on maximum oxygen consumption (VO2 max) specific to each individual.

Each exercise session;

  • 5 min warm-up = 30% of VO2 max
  • 20 min exercise = 50-60% of VO2 max
  • 5 minutes cooling in the form. The goal of aerobic exercise is to increase physical capacity, which is represented by maximum oxygen uptake (VO2max) and mechanical power generated during exercise. Training programs should be conducted at least 2 to 3 times per week (60-80% maximum work rate or 60% VO2max) for 30 to 60 minutes at moderate concentrations. These programs are effective in increasing aerobic capacity and power output in MS.
Patients will be given Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) 3 times a week for 6 weeks. 1 minute break between each exercise set
Active Comparator: Frenkel coordination exercise group - Control group
Patients will be given Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) 3 times a week for 6 weeks. There will be a 1 minute break between each exercise set.
Patients will be given Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) 3 times a week for 6 weeks. 1 minute break between each exercise set

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological - Irisin Hormone
Time Frame: 8 mounth
For the analysis of the level of iris, blood samples will be taken from gel biochemistry tubes as appropriate for the analyzes to be performed from the patients at the end of the aerobic capacity assessment. Blood samples will be separated by centrifugation at 3000rpm for 10min and the obtained sera will be placed in small portions in ependorf tubes and stored at -80 ° C until analysis. Irisin levels will be studied in accordance with the kit user manual using commercial ELISA (enzyme-linked immunosorbent assay) kits
8 mounth
Neurophysiological - EMG
Time Frame: 8 mounth
In the scope of EMG evaluation, the motor and sensory conduction studies of the ulnar and median nerve in the upper extremity, the peroneal and tibial nerves in the lower extremity, the F response and H-reflex study in the motor nerves, and the sensory conduction study of the sural nerve in the lower extremity are planned.
8 mounth
VO2 Max
Time Frame: 8 mounth
The VO2 max measurement will be performed using the incremental exercise test to determine the maximum aerobic capacity. After resting for 5 minutes (sitting on the ergometer), patients will be asked to start cycling on the ergometer starting at 25W. The load will be increased by 25W every 3 minutes until depletion.
8 mounth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiple Sclerosis Functional Composites (MSFC)
Time Frame: 8 mounth
Multiple Sclerosis Functional Composites (MSFC) was developed by the National MS Society's Clinical Outcomes Assessment Task Force. Objective assessment of functional disability score and help to maintain the standard of patient follow-up. It consists of 25 Step Walk Test, 9 Hole Peg Test, Step Auditory Serial Addition Test (PASAT) subtests. PASAT is used to measure the speed of auditory information processing, computational skills and attention from executive functions. It has two forms, A and B, and is performed with a standard voice recording. Each form has two subtests. In the first subtest, the numbers are repeated at three-second intervals, and the patient is expected to add the next number he heard. Each time, the patient must add the previous and the new number. 9 Perforated Peg Test is a test that measures upper extremity functions (hand and arm) and motor speed.
8 mounth
Ataxia Scale (SARA)
Time Frame: 8 mounth
The Ataxia Scale (SARA) is a scale used to assess ataxia including clinical dysfunction, limb movements, kinetic functions, posture and gait disorders, speech and oculomotor disorders. SARA subscores are posture and gait, speech, kinetic functions of the extremities
8 mounth
Leeds Multiple Sclerosis Quality of Life Scale (LMSQoL)
Time Frame: 8 mounth
The Leeds Multiple Sclerosis Quality of Life Scale (LMSQoL) was developed to assess the quality of life of individuals with MS. The eight-item form of this scale is directed towards fatigue, loneliness, energy, health concerns, family relationships, appearances, other people's attitudes, and the future. It is stated that LMSQoL is sensitive and reliable for the studied population and it is fast and easy to use in the clinical setting.
8 mounth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Nilüfer ÇETİŞLİ KORKMAZ, Pamukkale University
  • Principal Investigator: Zübeyde ERCAN, Firat University
  • Principal Investigator: Gökhan ALKAN, Firat University
  • Principal Investigator: Murat GÖNEN, Firat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 21, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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