Investigation of the Effects of Proprioceptive Neuromuscular Facilitation Exercises in Patients With Myasthenia Gravis

NCT06158815 | Completed

• 1 other identifier: KA-22017
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Myasthenia Gravis

Outcome Measures

Primary Outcomes (5)

• chalder fatigue scale

  It is an easy, fast and useful scale that evaluates fatigue through self-report. The final version of the scale consists of a total of 11 items, including a 7-item physical fatigue subsection and a 4-item mental fatigue subsection. The individual is asked to respond to the statements using a four-point Likert scale (less than usual, as much as usual, more than usual, much more than usual). Each item is scored between 0-3 and the total score varies between 0-33.

  baseline and immediately after the intervention

• Fatigue Impact Scale

  It is a multidimensional scale that evaluates the physical, cognitive and social effects of fatigue. The scale consists of a total of 40 questions: 10 questions for the physical effects subscale, 10 questions for the cognitive effects subscale, and 20 questions for the social effects subscale. Individuals fill out the scale by taking their last month into consideration. All questions are scored from "0" (no problem) to "4" (very big problem). Higher scores indicate increased degree of fatigue.

  baseline and immediately after the intervention

• fatigue severity scale

  It is a self-report scale consisting of 9 items that evaluates the degree of fatigue severity in the last week. For each item, the patient marks the most appropriate statement on a 7-point Likert scale ranging from 7=strongly agree to 1=strongly disagree. The scores obtained from each item are added up and the total value is divided by 9.

  baseline and immediately after the intervention

• Surface electromyography

  Surface electromyography measurements will be performed to measure the electrical signals coming from the muscles to determine the fatigue of the muscles. It has been shown in the literature that fatigue can be measured by power spectrum analysis in neuromuscular diseases. For this purpose, surface electromyography electrodes will be placed on the vastus lateralis muscle and the middle part of the deltoideus muscle and the participants will be asked to make maximum isometric contraction for 30 seconds. Electromyography signals will be analyzed and median frequencies between 0-5 seconds and 25-30 seconds will be determined and recorded. Wireless surface electromyography sensors and portable data acquisition system will be used to record and store measurements (Delsys (Delsys Inc. Natick, Massachusetts, USA)).

  baseline and immediately after the intervention

• Six Minute Walk Test

  It will be applied to evaluate functional capacity in accordance with the guidelines of the American Thoracic Society. In this test, the participant is walked down a 30-meter straight corridor. Participants are asked to walk for 6 minutes at the maximum speed they can walk during the test. The total distance walked is recorded. The distance walked per minute will also be recorded during this test. From these data, physical fatigue will be calculated according to the fatigue ambulatory index formula.

  baseline and immediately after the intervention

Secondary Outcomes (6)

• muscle strength

  baseline and immediately after the intervention

• functional capacity

  baseline and immediately after the intervention

• Myasthenia Gravis-Activities of Daily Living Scale

  baseline and immediately after the intervention

• Myasthenia Gravis Quality of Life Scale

  baseline and immediately after the intervention

• Myasthenia Gravis Composite Scale

  baseline and immediately after the intervention

Study Arms (2)

control group

NO INTERVENTION

Participants in the control group will be placed on a waiting list without any intervention during the 6-week study period.

exercise group

EXPERIMENTAL

Participants in the exercise group will have face-to-face Proprioceptive Neuromuscular Facilitation Exercises during the 6-week study period.

Other: proprioceptive neuromuscular facilitation exercise

Interventions

proprioceptive neuromuscular facilitation exercise OTHER

The basic principle of Proprioceptive Neuromuscular Facilitation exercises, which is defined as facilitating the responses of the neuromuscular mechanism by stimulating the proprioceptors, is that the movements in the human body have a rotational and oblique character and that a greater response can be obtained with movement against maximum resistance. It is aimed to achieve improvement in strength and movement ability through hand contacts, visual and verbal stimuli.

exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Altındag, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• sevim erdem özdamar, Professor

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• yeliz salcı, Assoc. Prof.

  Hacettepe University

  STUDY CHAIR

• rıdvan m adın, M.Sc.

  Hacettepe University

  STUDY CHAIR

• ayla fil balkan, Assoc. Prof.

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science, Research Assistant

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 6, 2023
• Study Start: December 28, 2022
• Primary Completion: July 9, 2024
• Study Completion: December 25, 2024
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)