Exercise for Stable Myasthenia Gravis

Phase 1

• Conditions: Myasthenia Gravis
• Interventions: Other: Exercise

• Registration Number: NCT01047761
• Lead Sponsor: Baltimore VA Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-28
• Last Update Posted: 2016-11-01
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
exercise	Exercise	Multimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening.

Primary Outcome Measures

Name	Time	Method
Cardiovascular Fitness, Economy of Gait, Physiologic Reserve	Baseline and 3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Maryland and Baltimore VA Medical Center; 🇺🇸 Baltimore, Maryland, United States