Clinical trial NCT06491238: Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis
Official title: Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myasthenia Gravis
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Feasibility of light and moderate intensity exercise
timeFrame: 12 weeks
measure: Acceptability of light and moderate intensity exercise
timeFrame: 12 weeks
measure: Tolerability of light and moderate intensity exercise
timeFrame: 12 weeks
Secondary outcomes:
measure: Cardiovascular Test - 6-minute walk test
timeFrame: 12 weeks
measure: Cardiovascular and Strength test
timeFrame: 12 weeks
measure: Strength Test - 1-RM Upper Limb
timeFrame: 12 weeks
measure: Strength Test - 1-RM Lower Limb
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
References: