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
  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

Resource links provided by NLM:


Further study details as provided by Baltimore VA Medical Center:

Primary Outcome Measures:
  • Cardiovascular Fitness, Economy of Gait, Physiologic Reserve [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
Arms Assigned Interventions
Experimental: exercise 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


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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047761

Contacts
Contact: Charlene Hafer-Macko, MD 410-328-3100 cmacko@grecc.umaryland.edu

Locations
United States, Maryland
University of Maryland and Baltimore VA Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Charlene Hafer-Macko, MD         
Sponsors and Collaborators
Baltimore VA Medical Center
University of Maryland
Investigators
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: August 19, 2013
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:
Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2014