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Exercise Intensity for Myasthenia Gravis (MG-Ex Trial)

N/A

Recruiting

Research Sponsored by HealthPartners Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-80

Diagnosis of generalized MG

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to compare the effects of light and moderate intensity exercise on health outcomes in individuals with neurological disorders or injuries. Participants will join a specialized exercise program and attend group sessions three times a week for

Who is the study for?

This trial is for individuals with Myasthenia Gravis, a condition causing muscle weakness. It's designed to test whether different exercise intensities affect their health outcomes. Participants will join the NeuroWell program and must be able to exercise three times a week for 12 weeks.

What is being tested?

The study compares light vs. moderate intensity exercises in managing Myasthenia Gravis symptoms. A total of 20 participants will be randomly assigned to one of two groups, exercising under supervision by Certified Exercise Physiologists at the Neuroscience Center.

What are the potential side effects?

Since this trial involves physical exercise, potential side effects may include muscle soreness, fatigue, or exacerbation of symptoms related to Myasthenia Gravis depending on individual tolerance and response to activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have been diagnosed with generalized myasthenia gravis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any cognitive issues that would affect my participation in the study.

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I have a condition like heart failure or lung disease that makes me unusually short of breath.

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I am not pregnant and do not plan to become pregnant during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cardiovascular Test - 6-minute walk test

Functional strength - Sit to stand test

Strength Test - 1-RM Lower Limb

+1 more

Secondary study objectives

Fatigue - Fatigue Severity Scale

MG-Activities of Daily Living (ADL)

MG-Quality of life (QOL)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Moderate intensity ExerciseExperimental Treatment1 Intervention

Aerobic intensity levels: HRR 40-59%, 12-13 Borg RPE Strength intensity levels: %1RM 60-80%, OMNI RPE 5-6

Group II: Light intensity ExerciseExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Moderate Intensity Exercise

2019

Completed Phase 4

~150

0 / 5Eligibility criteria met