NCT03743740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

December 3, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2019

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

November 8, 2018

Last Update Submit

March 15, 2020

Conditions

Myasthenia Gravis

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • respiratory functions

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

    6 weeks

  • 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 Outcomes (1)

  • Quality of Life Assessment

    6 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Interventions

Spinal stabilization exerciseOTHER

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.

Also known as: home based program
Group 1Group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (7)

  • Gilhus NE. Myasthenia Gravis. N Engl J Med. 2016 Dec 29;375(26):2570-2581. doi: 10.1056/NEJMra1602678. No abstract available.

    PMID: 28029925BACKGROUND

  • 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.

    PMID: 18296944BACKGROUND

  • 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.

    PMID: 27922503BACKGROUND

  • 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.

    PMID: 16780988BACKGROUND

  • 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.

    PMID: 26437790BACKGROUND

  • 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.

    PMID: 30230561BACKGROUND

  • 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.

    PMID: 26000922BACKGROUND

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 16, 2018

Study Start

December 3, 2018

Primary Completion

March 22, 2019

Study Completion

April 8, 2019

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations

TU(1)