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临床试验/NCT03743740
NCT03743740已完成不适用

The Effect of Spinal Stabilization Exercises on Fatigue, Muscle Strength, Pulmonary Functions and Functional Capacity in Patients With Myasthenia Gravis

Hacettepe University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
muscle strength of extremity muscle in patient with Myasthenia Gravis

研究概览

简要总结

Myasthenia Gravis (MG) is an autoimmune disease characterized by increased exercise-induced fatigue and muscle weakness. MG is a disease caused by impaired receptor function due to antibodies to nicotinic acetylcholine receptors in postsynaptic region in voluntary skeletal muscles.Spinal stabilization exercises, which use the basic principles of motor learning, aiming to improve the coordination, contraction rate and endurance of the body muscles by increasing kinesthetic awareness, can be used to strengthen body stability.

The aim of this study was to investigate the effects of spinal stabilization exercises on fatigue, muscle strength, pulmonary functions and functional capacity in patients with MG.

详细描述

Myasthenia Gravis (MG) is an autoimmune disease characterized by increased exercise-induced fatigue and muscle weakness. MG is a disease caused by impaired receptor function due to antibodies to nicotinic acetylcholine receptors in postsynaptic region in voluntary skeletal muscles. The disease usually begins with ptosis from ocular symptoms. With the progression of the disease, symptoms of bulbar muscles and extremity muscles are added to the ocular symptoms. Bulbar symptoms occur when speaking, swallowing, chewing difficulties and difficulty breathing, while the symptoms in the extremity muscles arise as the difficulty of raising the arms uphill and the strain of climbing stairs.

The weakness of the limb muscles is proximal and distal in the arms and more proximal muscles in the legs. As the disease progresses, weakness occurs in most striated muscles. This causes weakness in the trunk muscles.

In the literature, the physiotherapy methods used in MG patients include breathing exercises, aerobic exercises and resistant exercises.Spinal stabilization exercises enable activation of the trunk muscles.

Spinal stabilization exercises, which use the basic principles of motor learning, aiming to improve the coordination, contraction rate and endurance of the body muscles by increasing kinesthetic awareness, can be used to strengthen body stability. Spinal stabilization exercises are a type of exercise that aims more smooth limb movements with a strong spine, ensuring smoothness and stability of the spine. In the literature, there is no study using spinal stabilization exercises in MG patients. The aim of this study was to investigate the effects of spinal stabilization exercises on fatigue, muscle strength, pulmonary functions and functional capacity in patients with MG.

Method The study was planned as randomized, single-blind and cross-over. Randomization will be done with closed envelope system. Group 1 will be written on five sheets and group 2 will be written on another five sheets.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

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

入选标准

  • Being diagnosed with MG by a neurologist,
  • Aged between18-65 years,
  • To be in Stage II or III according to the Clinical Classification of the Medialia Gravis Functional Assessment (MGFA),
  • The Mini Mental Test score should be over 24 in order to be cooperative to the physiotherapist's instructions,
  • To volunteer to participate in the study.

排除标准

  • Having a cognitive problem and having a Mini Mental Test score below 24
  • To have had myasthenic crisis in the last month,
  • Modification of medical treatment and dose in the last month,
  • Systemic, orthopedic and neurological disease in addition to the disease
  • Participation in physiotherapy program in the last six months.

结局指标

主要结局

muscle strength of extremity muscle in patient with Myasthenia Gravis

时间窗: 6 weeks

change in muscle strength will be measured with a digital hand held dynamometer

fatigue perception

时间窗: 6 weeks

fatigue perception will be assessed with visual analog scale (VAS). VAS is a straight line with a length of 10 cm meaning of 0 is that I am not tired. The meaning of 10 is that I am too tired. According to the degree of fatigue patients feel, patients give a score in this range.

respiratory functions

时间窗: 6 weeks

respiratory functions will be assessed with respiratory function tests. Respiratory function tests will be performed with portable spirometry.

functional capacity

时间窗: 6 weeks

functional capacity will be assessed with 6 minute walk test. The 6-minute walk test will record the distance traveled in the 30-meter corridor at maximal speed for 6 minutes.

fatigue

时间窗: 6 weeks

fatigue will be assessed with fatigue severity scale (FSS). FSS is a scale with scores ranging from 7 to 63. It includes 9 questions. Increase of score in this scale means that fatigue severity is increasing.

次要结局

  • Quality of Life Assessment(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Naim Ceren

Principal Investigator

Hacettepe University

研究点 (2)

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