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

NCT06624345 | Completed

• 1 other identifier: 202002115A3
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myasthenia Gravis

Keywords

myasthenia gravis; inspiratory muscle training; respiratory muscle strength; spirometery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Dyspnea Severity Assessment

  Six weeks

• Forced expiratory volume at one second

  Six weeks

• Peak expiratory flow

  Six weeks

• Maximum expiratory pressure

  Six weeks

• Forced Vital Capacity

  Six weeks

Study Arms (2)

Inspiratory Muscle Training

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

Subjects received routine care.

Procedure: Control Group

Interventions

Inspiratory muscle training PROCEDURE

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.

Inspiratory Muscle Training

Control Group PROCEDURE

Subjects received routine care.

Control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung University: lead
• Chang Gung University of Science and Technology: collaborator
• Kaohsiung Chang Gung Memorial Hospital,Taiwan: collaborator

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Related Publications (1)

• Chang CL, Fang TP, Tsai HM, Chen HC, Liu SF, Lin HL, Liu JF. Inspiratory muscle training and aerobic exercise for respiratory muscle strength in myasthenia gravis post-hospitalization- a randomized controlled trial. BMC Pulm Med. 2025 May 27;25(1):266. doi: 10.1186/s12890-025-03733-7.

  PMID: 40426137 DERIVED

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

Control Groups

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)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jui-Fang Liu, PhD

  Chang Gung University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: January 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available 3 years after the registration
• Access Criteria: The data is available upon request from the principal investigator.

Locations

TW (1)