Exercise for Stable Myasthenia Gravis

Study Overview
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Brief Summary
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Generalized fatigue in myasthenia gravis results in physical deconditioning that reduces fitness and increases risk of obesity, hypertension, elevated cholesterol and type 2 diabetes. This study will examine how active and fit are 30 individuals with chronic, generalized myasthenic subjects. This study will also determine whether a 3 month home exercise program with aerobic, resistive, and pulmonary training can improve physical activity, strength, fitness, lung function and reduce cardiovascular disease risk.

Detailed Description
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Generalized fatigue in myasthenia gravis results in a sedentary lifestyle and profound physical deconditioning, leading to reduced fitness and increased risk of obesity, hypertension, dyslipidemia, and type 2 diabetes. This study will characterize the activity and fitness levels and cardiovascular disease risk profile in 30 chronic, generalized myasthenic subjects. Hypotheses are that a) subjects with myasthenia gravis are physically inactive with reduced fitness level and high incidence of obesity and poor cardiovascular disease risk profile, and b) a 3 month multi-modal home exercise program that includes aerobic, resistive, and pulmonary training components will improve physical activity, strength, fitness, dyspnea, body composition and reduce cardiovascular disease risk. Specific aims are to a) define the baseline physical activity and fitness levels and prevalence of insulin resistance and dyslipidemia in stable sedentary myasthenic subjects, b) determine whether a 3 month moderate intensity home exercise program is safe and feasible in deconditioned, stable myasthenic subjects and c) whether a 3 month comprehensive home exercise program can enhance fitness, strength, and lung function to improve physical activity and reduce cardiovascular disease risk.

Official Title
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Multi-modal Exercise Program for Chronic Stable Myasthenia Gravis

Conditions
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Myasthenia Gravis

Intervention / Treatment
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* Other: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stable generalized myasthenia gravis adults age 18-70 Exclusion Criteria: already performing regular exercise unstable angina recent (<3 month) myocardial infarction, stroke, hospitalization for major illness or major surgery chronic pain or orthopedic condition restricting exercise active cancer, excluding basal cell cancer anemia (HCT <30) pregnancy myasthenia gravis exacerbation in past 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br>Multimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening. | Other: Exercise<br>* 3 month exercise intervention, three days a week Progressive in duration - up to 1 hour daily; Progressive in intensity Multi-modal exercise program includes a) aerobic - walking, b) resistive training with therabands and core exercises, and c) breathing exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Fitness, Economy of Gait, Physiologic Reserve |  | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory function (6 minute walk, 5 day step activity and accelerometer data) |  | Baseline and 3 month | 
| Muscle strength by dynamometer |  | Baseline and 3 month | 
| Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale |  | Baseline and 3 months | 
| Cardiovascular risk profile (fasting glucose, oral glucose tolerance test, HbA1c, lipids), smoking status, and body mass index |  | Baseline and 3 months | 
| Body Composition by DEXA and CT of mid-thigh and hip |  | Baseline and 3 months | 
| Quantitative MG Scale |  | Baseline and 3 months | 
| Pulmonary function tests - FVC and maximal inspiratory and expiratory pressure |  | Baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myasthenia Gravis, Exercise, Fitness, Body Composition, Physical Activity, Pulmonary Function, Balance