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Trial Title:
Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis
NCT ID:
NCT06491238
Condition:
Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Light Intensity Exercise
Description:
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.
Arm group label:
Light intensity Exercise
Intervention type:
Behavioral
Intervention name:
Moderate Intensity Exercise
Description:
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.
Arm group label:
Moderate intensity Exercise
Summary:
The purpose of this pilot study is to examine the effect 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
individuals in the light intensity exercise group will be able to achieve the same
improvement in outcomes as the moderate intensity group.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
HealthPartners Neuroscience Center
Address:
City:
Saint Paul
Zip:
55130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trial Coordinator
Phone:
651-495-6363
Email:
ClincialTrials@HealthPartners.com
Start date:
September 16, 2024
Completion date:
July 2025
Lead sponsor:
Agency:
HealthPartners Institute
Agency class:
Other
Source:
HealthPartners Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06491238