Clinical Trial: Exercise for Stable Myasthenia Gravis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Baltimore VA Medical Center

Current Primary Outcome: Cardiovascular Fitness, Economy of Gait, Physiologic Reserve [ Time Frame: Baseline and 3 months ]

Original Primary Outcome: Cardiovascular Fitness [ Time Frame: Baseline and 3 months ]

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Baltimore VA Medical Center

Dates:
Date Received: January 12, 2010
Date Started: January 2010
Date Completion: December 2020
Last Updated: October 28, 2016
Last Verified: October 2016