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NCT Number: NCT06624345

Interval 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Control Group

Procedure

Subjects received routine care.

Primary outcomes

  1. Maximum inspiratory pressure

    Time frame: Six weeks

    Maximum inspiratory pressure was measured by instructing each subject to exert their maximum inspiratory force against a pressure gauge.

Secondary outcomes

  1. Dyspnea Severity Assessment

    Time frame: Six weeks

    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.

  2. Forced expiratory volume at one second

    Time frame: Six weeks

    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.

  3. Peak expiratory flow

    Time frame: Six weeks

    The peak expiratory flow was measured using a respiratory mechanics monitor during three forceful expirations.

  4. Maximum expiratory pressure

    Time frame: Six weeks

    Maximum expiratory pressure was measured by instructing each subject to exert their maximum expiratory force against a pressure gauge.

  5. Forced Vital Capacity

    Time frame: Six weeks

    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.

  6. Six-minute walk test

    Time frame: Six weeks

    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.

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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