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The Effect of Spinal Stabilization Exercises in Patients With Myasthenia Gravis

Primary Purpose

Myasthenia Gravis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Spinal stabilization exercise
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myasthenia Gravis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

muscle strength of extremity muscle in patient with Myasthenia Gravis
change in muscle strength will be measured with a digital hand held dynamometer
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.
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.
respiratory functions
respiratory functions will be assessed with respiratory function tests. Respiratory function tests will be performed with portable spirometry.
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.

Secondary Outcome Measures

Quality of Life Assessment
It will be evaluated with Myastenia GravisvQuality of Life Questionnaire 15

Full Information

First Posted
November 8, 2018
Last Updated
March 15, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03743740
Brief Title
The Effect of Spinal Stabilization Exercises in Patients With Myasthenia Gravis
Official Title
The Effect of Spinal Stabilization Exercises on Fatigue, Muscle Strength, Pulmonary Functions and Functional Capacity in Patients With Myasthenia Gravis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
April 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Spinal stabilization exercise
Other Intervention Name(s)
home based program
Intervention Description
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.
Primary Outcome Measure Information:
Title
muscle strength of extremity muscle in patient with Myasthenia Gravis
Description
change in muscle strength will be measured with a digital hand held dynamometer
Time Frame
6 weeks
Title
fatigue perception
Description
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.
Time Frame
6 weeks
Title
fatigue
Description
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.
Time Frame
6 weeks
Title
respiratory functions
Description
respiratory functions will be assessed with respiratory function tests. Respiratory function tests will be performed with portable spirometry.
Time Frame
6 weeks
Title
functional capacity
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Quality of Life Assessment
Description
It will be evaluated with Myastenia GravisvQuality of Life Questionnaire 15
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28029925
Citation
Gilhus NE. Myasthenia Gravis. N Engl J Med. 2016 Dec 29;375(26):2570-2581. doi: 10.1056/NEJMra1602678. No abstract available.
Results Reference
background
PubMed Identifier
18296944
Citation
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.
Results Reference
background
PubMed Identifier
27922503
Citation
Nicolle MW. Myasthenia Gravis and Lambert-Eaton Myasthenic Syndrome. Continuum (Minneap Minn). 2016 Dec;22(6, Muscle and Neuromuscular Junction Disorders):1978-2005. doi: 10.1212/CON.0000000000000415.
Results Reference
background
PubMed Identifier
16780988
Citation
Feasson L, Camdessanche JP, El Mandhi L, Calmels P, Millet GY. Fatigue and neuromuscular diseases. Ann Readapt Med Phys. 2006 Jul;49(6):289-300, 375-84. doi: 10.1016/j.annrmp.2006.04.015. Epub 2006 Apr 25. English, French.
Results Reference
background
PubMed Identifier
26437790
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.
Results Reference
background
PubMed Identifier
30230561
Citation
Salci Y, Karanfil E, Balkan AF, Kutukcu EC, 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.
Results Reference
background
PubMed Identifier
26000922
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.
Results Reference
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The Effect of Spinal Stabilization Exercises in Patients With Myasthenia Gravis

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