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

NCT ID: NCT06624345

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myasthenia Gravis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type 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

Subjects received routine care.

Group Type SHAM_COMPARATOR

Control Group

Intervention Type PROCEDURE

Subjects received routine care.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Control Group

Subjects received routine care.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung University of Science and Technology

OTHER

Sponsor Role collaborator

Kaohsiung Chang Gung Memorial Hospital,Taiwan

UNKNOWN

Sponsor Role collaborator

Chang Gung University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hui-Ling Lin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jui-Fang Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40426137 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202002115A3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of Inspiratory Muscle Exercise on Health
NCT07095179 NOT_YET_RECRUITING NA