Exercise for Stable Myasthenia Gravis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Baltimore VA Medical Center
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
Charlene Elaine Hafer-Macko, Baltimore VA Medical Center
ClinicalTrials.gov Identifier:
NCT01047761
First received: January 12, 2010
Last updated: August 19, 2013
Last verified: August 2013

January 12, 2010
August 19, 2013
January 2010
December 2015   (final data collection date for primary outcome measure)
Cardiovascular Fitness, Economy of Gait, Physiologic Reserve [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
Cardiovascular Fitness [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01047761 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Exercise for Stable Myasthenia Gravis
Multi-modal Exercise Program for Chronic Stable Myasthenia Gravis

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myasthenia Gravis
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

Experimental: exercise
Intervention: Other: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2020
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Charlene Hafer-Macko, MD 410-328-3100 cmacko@grecc.umaryland.edu
United States
 
NCT01047761
Myasthenia and Exercise
Yes
Charlene Elaine Hafer-Macko, Baltimore VA Medical Center
Baltimore VA Medical Center
University of Maryland
Principal Investigator: Charlene E Hafer-Macko, MD Baltimore VA Medical Center
Baltimore VA Medical Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP