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The Effect of Spinal Stabilization Exercises in Patients With Myasthenia Gravis

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ClinicalTrials.gov Identifier: NCT03743740
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Ali Naim Ceren, Hacettepe University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Myasthenia Gravis Other: Spinal stabilization exercise Not Applicable

Detailed Description:

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.

Then, these papers will be placed on the envelopes, these envelopes will be mixed in a box and patients will be asked to withdraw from these envelopes.

Thus, patients will be divided into 2 groups. Assessments will be made by Yeliz Salcı and Ebru Kütük Çalıkçı. The assessors will not know who is in the which group. Treatment intervention will be done by Ali Naim Ceren. The assessors will evaluate patients without knowing the patients' groups. So the work will be single blind. Group 1, 3 days per week for 6 weeks so that it will be taken to the physiotherapy program consisting of spinal stabilization exercises. Also the treatment will be supported by home program exercises. The patients will be rested for 4 weeks to eliminate the effects of the spinal stabilization program. After this period, only the home program will be given for 6 weeks. In Group 2; treatment will start with a 6-week home program, followed by a 4-week break.

At the end of this period to be 3 days a week for 6 weeks spinal stabilization exercise program will be implemented. In addition to this exercise program, patients will be given a home program. The home program will include breathing exercises tailored to the patient's needs, calisthenic exercises, and MAT activities.

Assessments will be made at the beginning of the treatment, after 6 weeks of treatment, at the end of 4 weeks of rest and at the end of 6 weeks of treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Spinal Stabilization Exercises on Fatigue, Muscle Strength, Pulmonary Functions and Functional Capacity in Patients With Myasthenia Gravis
Estimated Study Start Date : December 3, 2018
Estimated Primary Completion Date : March 22, 2019
Estimated Study Completion Date : April 8, 2019


Arm Intervention/treatment
Experimental: Group 1

first, patients will undergo spinal stabilization exercise and home based program 3 days per week for 6 weeks.

then, exercises will be suspended for 4 weeks. then, patients will undergo home based program 3 days per week for 6 weeks.

Other: Spinal stabilization exercise
The effects of spinal stabilization exercise in patients with myasthenia gravis will be investigated.There is no study in the literature that previously applied spinal stabilization exercises in patients with myasthenia gravis. The benefits of spinal stabilization exercises in other diseases are shown.
Other Name: home based program

Experimental: Group 2
first, patients will undergo home based program 3 days per week for 6 weeks. then, exercises will be suspended for 4 weeks. then, patients will undergo spinal stabilization exercise and home based program 3 days per week for 6 weeks.
Other: Spinal stabilization exercise
The effects of spinal stabilization exercise in patients with myasthenia gravis will be investigated.There is no study in the literature that previously applied spinal stabilization exercises in patients with myasthenia gravis. The benefits of spinal stabilization exercises in other diseases are shown.
Other Name: home based program




Primary Outcome Measures :
  1. muscle strength of extremity muscle in patient with Myasthenia Gravis [ Time Frame: 6 weeks ]
    change in muscle strength will be measured with a digital hand held dynamometer

  2. fatigue perception [ Time Frame: 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.

  3. fatigue [ Time Frame: 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.

  4. respiratory functions [ Time Frame: 6 weeks ]
    respiratory functions will be assessed with respiratory function tests. Respiratory function tests will be performed with portable spirometry.

  5. functional capacity [ Time Frame: 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.


Secondary Outcome Measures :
  1. Quality of Life Assessment [ Time Frame: 6 weeks ]
    It will be evaluated with Myastenia GravisvQuality of Life Questionnaire 15



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743740


Contacts
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Contact: Ali N Ceren +90 554 5662055 alinaimceren@gmail.com

Sponsors and Collaborators
Hacettepe University

Publications:
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Responsible Party: Ali Naim Ceren, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03743740     History of Changes
Other Study ID Numbers: KA-17132
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myasthenia Gravis
Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases