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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

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