Clinical trial NCT06624345: Interval Inspiratory Training and Aerobic Exercise for Muscle Recovery in Myasthenia Gravis Post-Hospitalization
Official title: Inspiratory Training and Aerobic Exercise for Muscle Recovery in Myasthenia Gravis Post-Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myasthenia Gravis
Keywords: myasthenia gravis
inspiratory muscle training
respiratory muscle strength
spirometery
Lead sponsor: Chang Gung University
Sponsor class: OTHER
Collaborators: name: Chang Gung University of Science and Technology
name: Kaohsiung Chang Gung Memorial Hospital,Taiwan
First posted: 2024-10-03
Enrollment: 68
Sex: ALL
Minimum age (years): 18
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 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.

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.

Eligibility criteria: 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 \&amp;lt; 0.7 and FEV1 \&amp;lt; 50% predicted)

Primary outcomes:
measure: Maximum inspiratory pressure
timeFrame: Six weeks
Secondary outcomes:
measure: Dyspnea Severity Assessment
timeFrame: Six weeks
measure: Forced expiratory volume at one second
timeFrame: Six weeks
measure: Peak expiratory flow
timeFrame: Six weeks
measure: Maximum expiratory pressure
timeFrame: Six weeks
measure: Forced Vital Capacity
timeFrame: Six weeks
measure: Six-minute walk test
timeFrame: Six weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University of Science and Technology
name: Jui-Fang Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: