Interval Inspiratory Training and Aerobic Exercise for Muscle Recovery in Myasthenia Gravis Post-Hospitalization

Inspiratory Training and Aerobic Exercise for Muscle Recovery in Myasthenia Gravis Post-Hospitalization

The goal of this clinical trial is to determine whether inspiratory muscle training aids in the recovery of respiratory muscle strength and helps prevent further muscle weakness in patients with myasthenia gravis.

The primary research questions are:

Does inspiratory muscle training enhance respiratory muscle strength recovery? Does the intervention lead to improved lung volumes? Participants underwent daily inspiratory muscle training and aerobic exercise for six consecutive weeks.

Study Overview

• Status: Completed
• Conditions: Myasthenia Gravis
• Intervention / Treatment: Procedure: Control Group; Procedure: Inspiratory muscle training

Detailed Description

Patients with myasthenia gravis who experience acute exacerbations requiring hospitalization often suffer a significant decline in muscle strength, followed by partial recovery after the acute phase. This randomized controlled trial aims to evaluate the potential of early inspiratory muscle training and aerobic exercise in promoting muscle strength recovery and preventing further weakness. The study will assess differences in lung function, respiratory muscle strength, and dyspnea levels following the intervention after patients are discharged from the hospital post-acute exacerbation.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hospitalized due to a myasthenia gravis crisis
• Cleared for discharge from the hospital
• Capable of completing six weeks of home-based respiratory muscle and exercise training

Exclusion Criteria:

• Myasthenia Gravis Foundation of America (MGFA) classification I or V
• Presence of concurrent heart, kidney, liver, or metabolic diseases, or malignant tumors
• Ability to follow exercise instructions
• New York Heart Association (NYHA) Class III/IV
• Pulmonary disease (FEV1/FVC ratio < 0.7 and FEV1 < 50% predicted)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group; Subjects received routine care.	Procedure: Control Group; Subjects received routine care.
Experimental: Inspiratory Muscle Training; Subjects participated in a combination of inspiratory muscle training and aerobic exercise for approximately 30 minutes per day over a period of six weeks.	Procedure: Inspiratory muscle training; Patients in the IMT group received the intervention using a threshold loading device set at a pressure range of 5-39 cmH₂O. They were instructed to perform six sets of five breaths, totaling 30 breaths, twice daily for six weeks. Additionally, the aerobic exercise regimen included upper limb exercises (raising arms without resistance), a lower limb stepping warm-up, and a walking routine consisting of 5 minutes of slow walking, 2 minutes of brisk walking, and another 5 minutes of slow walking, for a total of 30 minutes per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum inspiratory pressure	Maximum inspiratory pressure was measured by instructing each subject to exert their maximum inspiratory force against a pressure gauge.	Six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnea Severity Assessment	Dyspnea severity was assessed by a rating of perceived exertion, using the Borg Scale which ranged from 0 (no respiratory difficulty) to 10 (extreme respiratory difficulty), with higher scores indicating more severe breathing difficulty.	Six weeks
Forced expiratory volume at one second	The forced expiratory volume at one second was obtained, using spirometry, by having the patient take a deep breath and then exhale forcefully. The test results were based on three reproducible measurements.	Six weeks
Peak expiratory flow	The peak expiratory flow was measured using a respiratory mechanics monitor during three forceful expirations.	Six weeks
Maximum expiratory pressure	Maximum expiratory pressure was measured by instructing each subject to exert their maximum expiratory force against a pressure gauge.	Six weeks
Forced Vital Capacity	Forced vital capacity was measured using spirometry. Patients were instructed to take a deep breath and then exhale forcefully. The results were based on the average of three reproducible measurements.	Six weeks
Six-minute walk test	Patients were instructed to walk as fast as possible, while pulse oxygen saturation levels, heart rate, and Borg scale scores were monitored and recorded before, during, and after the test.	Six weeks

Collaborators and Investigators

• Sponsor: Chang Gung University
• Collaborators: Chang Gung University of Science and Technology; Kaohsiung Chang Gung Memorial Hospital,Taiwan
• Investigators: Principal Investigator: Jui-Fang Liu, PhD, Chang Gung University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 12, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: inspiratory muscle training; myasthenia gravis; respiratory muscle strength; spirometery
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Neoplasms; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Respiration Disorders; Neoplasms by Site; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Nervous System Neoplasms; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Respiratory Aspiration; Muscle Weakness; Myasthenia Gravis
• Other Study ID Numbers: 202002115A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data is available upon request from the principal investigator.
• IPD Sharing Time Frame: The data will become available 3 years after the registration
• IPD Sharing Access Criteria: The data is available upon request from the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No