Exercise for Stable Myasthenia Gravis

Myasthenia Gravis Clinical Trial

Official title:

Multi-modal Exercise Program for Chronic Stable Myasthenia Gravis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01047761
• Other study ID #: Myasthenia and Exercise
• Status: Recruiting
• Phase: Phase 1
• First received: January 12, 2010
• Last updated: October 28, 2016
• Start date: January 2010
• Est. completion date: December 2020

Study information

• Verified date: October 2016
• Source: Baltimore VA Medical Center
• Contact: Charlene Hafer-Macko, MD
• Phone: 410-328-3100
• Email: cmacko[@]grecc.umaryland.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland and Baltimore VA Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Baltimore VA Medical Center	University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Fitness, Economy of Gait, Physiologic Reserve		Baseline and 3 months	No
Secondary	Ambulatory function (6 minute walk, 5 day step activity and accelerometer data)		Baseline and 3 month	No
Secondary	Muscle strength by dynamometer		Baseline and 3 month	No
Secondary	Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale		Baseline and 3 months	No
Secondary	Cardiovascular risk profile (fasting glucose, oral glucose tolerance test, HbA1c, lipids), smoking status, and body mass index		Baseline and 3 months	No
Secondary	Body Composition by DEXA and CT of mid-thigh and hip		Baseline and 3 months	No
Secondary	Quantitative MG Scale		Baseline and 3 months	No
Secondary	Pulmonary function tests - FVC and maximal inspiratory and expiratory pressure		Baseline and 3 months	No

External Links

•   Myasthenia Gravis Foundation of America
•   University of Maryland Myasthenia Gravis Center