The Effect of Spinal Stabilization Exercises in Patients With Myasthenia Gravis

Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743740
• Other study ID #: KA-17132
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: April 8, 2019

Study information

• Verified date: March 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 8, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Akuthota V, Ferreiro A, Moore T, Fredericson M. Core stability exercise principles. Curr Sports Med Rep. 2008 Feb;7(1):39-44. doi: 10.1097/01.CSMR.0000308663.13278.69. Review. — View Citation

Elsheikh B, Arnold WD, Gharibshahi S, Reynolds J, Freimer M, Kissel JT. Correlation of single-breath count test and neck flexor muscle strength with spirometry in myasthenia gravis. Muscle Nerve. 2016 Jan;53(1):134-6. doi: 10.1002/mus.24929. — View Citation

Féasson L, Camdessanché JP, El Mandhi L, Calmels P, Millet GY. Fatigue and neuromuscular diseases. Ann Readapt Med Phys. 2006 Jul;49(6):289-300, 375-84. Epub 2006 Apr 25. Review. English, French. — View Citation

Gilhus NE. Myasthenia Gravis. N Engl J Med. 2016 Dec 29;375(26):2570-2581. doi: 10.1056/NEJMra1602678. Review. — View Citation

Nicolle MW. Myasthenia Gravis and Lambert-Eaton Myasthenic Syndrome. Continuum (Minneap Minn). 2016 Dec;22(6, Muscle and Neuromuscular Junction Disorders):1978-2005. Review. — View Citation

Salci Y, Karanfil E, Balkan AF, Kütükçü EÇ, Ceren AN, Ayvat F, Bekircan-Kurt CE, Armutlu K. Functional exercise capacity evaluated by timed walk tests in myasthenia gravis. Muscle Nerve. 2019 Feb;59(2):208-212. doi: 10.1002/mus.26345. Epub 2018 Oct 17. — View Citation

Yang Y, Zhang M, Guo J, Ma S, Fan L, Wang X, Li C, Guo P, Wang J, Li H, Li Z. Quality of life in 188 patients with myasthenia gravis in China. Int J Neurosci. 2016;126(5):455-62. doi: 10.3109/00207454.2015.1038712. Epub 2015 Jun 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle strength of extremity muscle in patient with Myasthenia Gravis	change in muscle strength will be measured with a digital hand held dynamometer	6 weeks
Primary	fatigue perception	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.	6 weeks
Primary	fatigue	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.	6 weeks
Primary	respiratory functions	respiratory functions will be assessed with respiratory function tests. Respiratory function tests will be performed with portable spirometry.	6 weeks
Primary	functional capacity	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.	6 weeks
Secondary	Quality of Life Assessment	It will be evaluated with Myastenia GravisvQuality of Life Questionnaire 15	6 weeks