Clinical trial NCT01047761: Exercise for Stable Myasthenia Gravis
Official title: Multi-modal Exercise Program for Chronic Stable Myasthenia Gravis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Myasthenia Gravis
Keywords: Myasthenia Gravis
Exercise
Fitness
Body Composition
Physical Activity
Pulmonary Function
Balance
Lead sponsor: Baltimore VA Medical Center
Sponsor class: FED
Collaborators: name: University of Maryland
First posted: 2010-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular Fitness, Economy of Gait, Physiologic Reserve
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Ambulatory function (6 minute walk, 5 day step activity and accelerometer data)
timeFrame: Baseline and 3 month
measure: Muscle strength by dynamometer
timeFrame: Baseline and 3 month
measure: Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale
timeFrame: Baseline and 3 months
measure: Cardiovascular risk profile (fasting glucose, oral glucose tolerance test, HbA1c, lipids), smoking status, and body mass index
timeFrame: Baseline and 3 months
measure: Body Composition by DEXA and CT of mid-thigh and hip
timeFrame: Baseline and 3 months
measure: Quantitative MG Scale
timeFrame: Baseline and 3 months
measure: Pulmonary function tests - FVC and maximal inspiratory and expiratory pressure
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland and Baltimore VA Medical Center
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center
name: Charlene E Hafer-Macko, MD
role: PRINCIPAL_INVESTIGATOR
References: