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临床试验/NCT04121637
NCT04121637Unknown不适用

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

Firat University0 个研究点目标入组 22 人开始时间: 2019年10月21日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
22
主要终点
Physiological - Irisin Hormone

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants and the person who will make the analysis will not know the applications

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Physiological - Irisin Hormone

时间窗: 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

Neurophysiological - EMG

时间窗: 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.

VO2 Max

时间窗: 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.

次要结局

  • Multiple Sclerosis Functional Composites (MSFC)(8 mounth)
  • Leeds Multiple Sclerosis Quality of Life Scale (LMSQoL)(8 mounth)
  • Ataxia Scale (SARA)(8 mounth)

研究者

发起方
Firat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Furkan BİLEK

Principal Investigator

Firat University

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