Exercise for Stable Myasthenia Gravis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myasthenia Gravis |
Other: Exercise |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multi-modal Exercise Program for Chronic Stable Myasthenia Gravis |
- Cardiovascular Fitness, Economy of Gait, Physiologic Reserve [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
- Ambulatory function (6 minute walk, 5 day step activity and accelerometer data) [ Time Frame: Baseline and 3 month ] [ Designated as safety issue: No ]
- Muscle strength by dynamometer [ Time Frame: Baseline and 3 month ] [ Designated as safety issue: No ]
- Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
- Cardiovascular risk profile (fasting glucose, oral glucose tolerance test, HbA1c, lipids), smoking status, and body mass index [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
- Body Composition by DEXA and CT of mid-thigh and hip [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
- Quantitative MG Scale [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
- Pulmonary function tests - FVC and maximal inspiratory and expiratory pressure [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2020 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
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Other: Exercise
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
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Charlene Hafer-Macko, MD | 410-328-3100 | cmacko@grecc.umaryland.edu |
| United States, Maryland | |
| University of Maryland and Baltimore VA Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Principal Investigator: Charlene Hafer-Macko, MD | |
| Principal Investigator: | Charlene E Hafer-Macko, MD | Baltimore VA Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Charlene Elaine Hafer-Macko, Myasthenia Gravis and Exercise, Baltimore VA Medical Center |
| ClinicalTrials.gov Identifier: | NCT01047761 History of Changes |
| Other Study ID Numbers: | Myasthenia and Exercise |
| Study First Received: | January 12, 2010 |
| Last Updated: | March 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Baltimore VA Medical Center:
|
Myasthenia Gravis Exercise Fitness Body Composition |
Physical Activity Pulmonary Function Balance |
Additional relevant MeSH terms:
|
Myasthenia Gravis Muscle Weakness Autoimmune Diseases of the Nervous System Nervous System Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Autoimmune Diseases |
Immune System Diseases Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Pathologic Processes Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013