- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06491238
Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis (MG-Ex)
March 20, 2026 updated by: HealthPartners Institute
The overall purpose of this pilot study is to examine the feasibility, acceptability, and tolerability of light and moderate intensity exercise in adults with MGeffect of light vs. moderate intensity exercise on health outcomes.
Participants will be enrolled into the NeuroWell exercise program, which is geared toward individuals with neurological disorders or injuries and led by Certified Exercise Physiologists (CEPs) at the HealthPartners Neuroscience Center.
A total of 20 people with MG will be enrolled in this study and participate in a small group exercise program 3 times a week for 12 weeks.
Participants will be randomized into two exercise groups: 1) Light intensity or 2) Moderate intensity.
We hypothesize that light and moderate intensity exercise will be feasible, acceptable, and tolerable in adults with MG and that individuals in the light intensity exercise group will be able to achieve the same improvement in health outcomes as the moderate intensity group.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Coordinator
- Phone Number: 651-495-6363
- Email: ClinicalTrials@HealthPartners.com
Study Locations
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55130
- Recruiting
- HealthPartners Neuroscience Center
-
Contact:
- Clinical Trial Coordinator
- Phone Number: 651-495-6363
- Email: ClincialTrials@HealthPartners.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Ability to provide and provision of signed and dated informed consent form.
- Age 18-80
- Diagnosis of generalized MG.
- On a stable MG prescription medication regimen for the last 3 months.
Exclusion Criteria:
- Non-English speaking
- Regular exercise participation within the month prior to study enrollment or any outside exercise participation during the study intervention period.
- Significant cognitive impairment of any etiology that would impact study participation.
- History of heart failure, chronic lung disease, angina or any other condition that causes unreasonable shortness of breath on exertion.
- History of any serious neurological, psychiatric, or substance use disorders that would impact study participation.
- Women who are currently pregnant or planning to become pregnant during the study.
- Any other medical conditions that could affect their ability to participate in exercise for the study duration (as determined by study investigators).
- Active participation or past participation ≤3 months in any other interventional research study.
- Unwilling to participate in all study related activities.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Light intensity Exercise
Aerobic intensity levels: Heart rate reserve (HRR) 30-39%, 9-11 Borg Rate of Perceived Exertion (RPE) Strength intensity levels: %One Repetition Max (1RM) 40-50%, OMNI RPE 1-4
|
12 weeks light intensity strength and endurance NeuroWell exercise program, specifically developed for individuals with neurological disorders or injuries.
Participants have the intensity goals descripted in the experimental arm.
|
|
Experimental: Moderate intensity Exercise
Aerobic intensity levels: HRR 40-59%, 12-13 Borg RPE Strength intensity levels: %1RM 60-80%, OMNI RPE 5-6
|
12 weeks moderate intensity strength and endurance NeuroWell exercise program, specifically developed for individuals with neurological disorders or injuries.
Participants have the intensity goals descripted in the experimental arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of light and moderate intensity exercise
Time Frame: 12 weeks
|
Percent of participants recruited of potential participants contacted.
Range: [0-100].
Higher percentage indicates higher feasibility
|
12 weeks
|
|
Acceptability of light and moderate intensity exercise
Time Frame: 12 weeks
|
Percent of participants who complete the program of participants who start the program.
Range: [0-100].
Higher percentage indicates higher acceptability
|
12 weeks
|
|
Tolerability of light and moderate intensity exercise
Time Frame: 12 weeks
|
Percent of classes participants complete during the course of the program.
Range: [0-100].
Higher percentage indicates higher tolerability.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular Test - 6-minute walk test
Time Frame: 12 weeks
|
Pre-post change in distance a person can walk during the 6-minute walk test.
Change = Post distance - pre distance.
Larger positive difference in distance indicates a larger improvement in cardiovascular health from pre-post program.
|
12 weeks
|
|
Strength Test - 1-RM Upper Limb
Time Frame: 12 weeks
|
Pre-post change in weight that can be lifted during the 1-RM test.
Change = Post 1-RM upper limb weight -pre 1-RM upper limb weight.
Larger positive difference in weight lifted indicates a larger improvement in upper limb strength from pre-post program.
|
12 weeks
|
|
Strength Test - 1-RM Lower Limb
Time Frame: 12 weeks
|
Pre-post change in weight that can be lifted during the 1-RM test.
Change = Post 1-RM lower limb weight -pre 1-RM lower limb weight.
Larger positive difference in weight lifted indicates a larger improvement in lower limb strength from pre-post program.
|
12 weeks
|
|
Cardiovascular and Strength test
Time Frame: 12 weeks
|
Pre-post change in time it takes a person to transfer from seated to standing position and then back to seated position 5 times.
Change = Post time- pre time.
Larger positive difference in time indicates a larger improvement in cardiovascular health and strength from pre-post program.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 16, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
June 21, 2024
First Submitted That Met QC Criteria
June 30, 2024
First Posted (Actual)
July 9, 2024
Study Record Updates
Last Update Posted (Actual)
March 23, 2026
Last Update Submitted That Met QC Criteria
March 20, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neuromuscular Diseases
- Autoimmune Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Neurodegenerative Diseases
- Paraneoplastic Syndromes, Nervous System
- Nervous System Neoplasms
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Myasthenia Gravis
Other Study ID Numbers
- A24-169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myasthenia Gravis
-
Myasthenia Gravis Foundation of AmericaAlira HealthRecruitingMyasthenia Gravis | Myasthenia Gravis, Generalized | Myasthenia Gravis Crisis | Myasthaenia Gravis | Myasthenia Gravis, Ocular | Myasthenia Gravis, Thymectomy | Myasthenia Gravis, Adult Form | Myasthenia Gravis Generalised | Myasthenia Gravis, MuSK | Myasthenia Gravis Exacerbations | Myasthenia | Myasthenia... and other conditionsUnited States
-
Assiut UniversityRecruitingNervous System Diseases | Autoimmune Diseases of the Nervous System | Thymoma | Myasthenia Gravis | Neuromuscular Junction Diseases | Myasthenia Gravis, Generalized | Myasthenia Gravis Crisis | Myasthenia Gravis, Ocular | Myasthenia Gravis, Juvenile Form | Thymus Hyperplasia | Myasthenia Gravis With Exacerbation... and other conditionsEgypt
-
argenxRecruitingGeneralized Myasthenia Gravis | Myasthenia Gravis | gMG | Generalized Myasthenia Gravis (gMG) | MG | AChR-Ab Seropositive Generalized Myasthenia GravisUnited States, Poland, Italy, Belgium, Spain
-
argenxRecruitingGeneralized Myasthenia Gravis | Myasthenia Gravis | gMG | Generalized Myasthenia Gravis (gMG) | MG | AChR-Ab Seropositive Generalized Myasthenia GravisUnited States, Spain, Belgium, Poland, Italy
-
University of Colorado, DenverargenxRecruitingMyasthenia Gravis Crisis | Myasthenia Gravis Exacerbations | AChR Myasthenia GravisUnited States
-
Shanghai Zhongshan HospitalHuashan Hospital; West China Hospital; Tang-Du Hospital; Second Affiliated Hospital... and other collaboratorsNot yet recruitingMyasthenia Gravis Associated With Thymoma | Efgartigimod | Intravenous ImmunoglobulinChina
-
argenxCompletedGeneralized Myasthenia Gravis | gMG | MG - Myasthenia GravisGeorgia, United States, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain
-
argenxActive, not recruitingGeneralized Myasthenia Gravis | Myasthenia Gravis | Myasthenia Gravis, Generalized | gMGUnited States, Belgium, Denmark, Germany, China, Netherlands, Norway, Spain, Saudi Arabia, United Kingdom, Czechia, Serbia, Poland, Greece, Georgia, Romania, Finland, Hungary, France, Canada, Portugal, Cyprus
-
Universiti Putra MalaysiaEnrolling by invitationExperimental MyastheniaChina
-
Universiti Putra MalaysiaCompletedExperimental MyastheniaChina
Clinical Trials on Light Intensity Exercise
-
Wayne State UniversityCompletedChildren | AdolescentsUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
The Netherlands Cancer InstituteDutch Cancer SocietyCompletedHodgkin Lymphoma | Diffuse Large B Cell LymphomaNetherlands
-
Hospices Civils de LyonCompleted
-
Peking University Sixth HospitalBeijing HuiLongGuan Hospital; Yan'an Third People's HospitalRecruiting
-
University of Texas at AustinRecruiting
-
University of AlbertaAlberta Diabetes InstituteCompletedExercise Intensity, Glycemic Control and Abdominal Fat in People With Type 2 Diabetes: A Pilot StudyType 2 Diabetes MellitusCanada
-
Western University, CanadaCompleted
-
National Center for Complementary and Integrative...Completed