Clinical trial NCT06158815: Investigation of the Effects of Proprioceptive Neuromuscular Facilitation Exercises in Patients with Myasthenia Gravis
Official title: Investigation of the Effects of Proprioceptive Neuromuscular Facilitation Exercises on Fatigue, Muscle Strength and Functional Parameters in Patients with Myasthenia Gravis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myasthenia Gravis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate of the effects of proprioceptive neuromuscular facilitation exercises on fatigue, muscle strength and functional parameters in patient with Myasthenia Gravis. The main questions it aims to answer are:

* Do proprioceptive neuromuscular facilitation exercises reduce fatigue in patients with Myasthenia Gravis?
* Do proprioceptive neuromuscular facilitation exercises increase muscle strength in patients with Myasthenia Gravis?
* Do proprioceptive neuromuscular facilitation exercises improve functional parameters in patients with Myasthenia Gravis?
* How well can patients with Myasthenia Gravis tolerate proprioceptive neuromuscular facilitation exercises? Participants will be divided into 2 groups as control group and exercise group with block randomization method. In this single-blind randomized controlled study, the participants in the control group will be placed on a waiting list without any intervention during the 6-week study period and at the end of the study, the interventions applied to the exercise group will be applied exactly the same. Proprioceptive neuromuscular facilitation exercises will be applied to the exercise group 3 days a week, 1 hour a day for 6 weeks. Individuals will be evaluated at the beginning and at the end of the study.

Researchers will compare exercise and control group to see if there are effects of proprioceptive neuromuscular exercises patients with Myasthenia Gravis.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* Being between the ages of 18-65
* It must be confirmed by the Neurologist that the patient has been diagnosed with adult onset and Achr+ generalized Myasthenia Gravis and has been in a stable condition for the last 6 months.
* Being in class II or III according to the American Myasthenia Gravis Foundation Clinical Classification

Exclusion Criteria:

* Having a cognitive problem or having a Mini Mental Test score below 24
* Change in the type and dose of medical treatment within the last 6 months
* Having another cardiorespiratory, metabolic, systemic, rheumatological, orthopaedic and neurological disease (unstable and at a level that prevents participation in the exercise programme) in addition to Myasthenia Gravis
* Having a body mass index below 17 kg/m2 and above 30 kg/m2
* Having participated in any physiotherapy program any intervention study for the last 6 months
* Having undergone pregnancy, birth or surgical operation in the last 6 months.

Primary outcomes:
measure: chalder fatigue scale
timeFrame: baseline and immediately after the intervention
measure: Fatigue Impact Scale
timeFrame: baseline and immediately after the intervention
measure: fatigue severity scale
timeFrame: baseline and immediately after the intervention
measure: Surface electromyography
timeFrame: baseline and immediately after the intervention
measure: Six Minute Walk Test
timeFrame: baseline and immediately after the intervention
Secondary outcomes:
measure: muscle strength
timeFrame: baseline and immediately after the intervention
measure: functional capacity
timeFrame: baseline and immediately after the intervention
measure: Myasthenia Gravis-Activities of Daily Living Scale
timeFrame: baseline and immediately after the intervention
measure: Myasthenia Gravis Quality of Life Scale
timeFrame: baseline and immediately after the intervention
measure: Myasthenia Gravis Composite Scale
timeFrame: baseline and immediately after the intervention
measure: visual analog scale
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Physical Therapy and Rehabilitation
state: Altındag
Study officials:
affiliation: Hacettepe University
name: sevim erdem özdamar, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: yeliz salcı, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: rıdvan m adın, M.Sc.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: ali n ceren, M.Sc.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: ayla fil balkan, Assoc. Prof.
role: STUDY_CHAIR
References: