Myasthenia GravisNCT06624345
Interval Inspiratory Training and Aerobic Exercise for Muscle Recovery in Myasthenia Gravis Post-Hospitalization
A study testing Inspiratory muscle training in people with Myasthenia Gravis, run by Chang Gung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Inspiratory muscle training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myasthenia Gravis
- Being tested
- Inspiratory muscle training, Control Group
- Keywords
- myasthenia gravis, inspiratory muscle training, respiratory muscle strength, spirometery
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingProcedure or surgery
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 GroupProcedure or surgery
Subjects received routine care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Inspiratory muscle training |
| Control group | Sham comparator | Subjects received routine care. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum inspiratory pressure
Maximum inspiratory pressure was measured by instructing each subject to exert their maximum inspiratory force against a pressure gauge.
Measured: Six weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: Six weeks
Peak expiratory flow
The peak expiratory flow was measured using a respiratory mechanics monitor during three forceful expirations.
Measured: Six weeks
Maximum expiratory pressure
Maximum expiratory pressure was measured by instructing each subject to exert their maximum expiratory force against a pressure gauge.
Measured: 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.
Measured: 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.
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung University of Science and Technology, Kaohsiung Chang Gung Memorial Hospital,Taiwan
- Responsible party
- Principal investigator, Hui-Ling Lin, Chang Gung Memorial Hospital
- Investigators
- Jui-Fang Liu, PhD, Principal investigator, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624345
- Sponsor's protocol ID
- 202002115A3
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data is available upon request from the principal investigator.
Publications
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.
PubMed 40426137
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Training and Aerobic Exercise for Muscle Recovery in Myasthenia Gravis Post-Hospitalization
- ClinicalTrials.gov ID
- NCT06624345
- Acronym / sponsor ID
- 202002115A3
- Conditions
- Myasthenia Gravis
- Keywords
- myasthenia gravis, inspiratory muscle training, respiratory muscle strength, spirometery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Collaborators
- Chang Gung University of Science and Technology, Kaohsiung Chang Gung Memorial Hospital,Taiwan
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Procedure: Inspiratory muscle trainingSubjects participated in a combination of inspiratory muscle training and aerobic exercise for approximately 30 minutes per day over a period of six weeks. |
| Control group | Sham comparator | Procedure: Control GroupSubjects received routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainingPatients 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. | Procedure or surgery | Inspiratory Muscle Training |
| Control GroupSubjects received routine care. | Procedure or surgery | Control group |
Primary outcome
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.
6 secondary outcomes
Dyspnea Severity Assessment
Time frame: Six weeks
Forced expiratory volume at one second
Time frame: Six weeks
Peak expiratory flow
Time frame: Six weeks
Maximum expiratory pressure
Time frame: Six weeks
Forced Vital Capacity
Time frame: Six weeks
Six-minute walk test
Time frame: Six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 40426137Chang 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.
- Individual participant dataSharing planned: Yes. The data is available upon request from the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jui-Fang Liu, PhD principal investigator
Chang Gung University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Myasthenia Gravis, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum inspiratory pressure (time frame: Six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06624345, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.