- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01047761
Exercise for Stable Myasthenia Gravis
October 28, 2016 updated by: Charlene Elaine Hafer-Macko, Baltimore VA Medical Center
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland and Baltimore VA Medical Center
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Principal Investigator:
- Charlene Hafer-Macko, MD
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: exercise
Multimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiovascular Fitness, Economy of Gait, Physiologic Reserve
Time Frame: Baseline and 3 months
|
Baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ambulatory function (6 minute walk, 5 day step activity and accelerometer data)
Time Frame: Baseline and 3 month
|
Baseline and 3 month
|
Muscle strength by dynamometer
Time Frame: Baseline and 3 month
|
Baseline and 3 month
|
Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale
Time Frame: Baseline and 3 months
|
Baseline and 3 months
|
Cardiovascular risk profile (fasting glucose, oral glucose tolerance test, HbA1c, lipids), smoking status, and body mass index
Time Frame: Baseline and 3 months
|
Baseline and 3 months
|
Body Composition by DEXA and CT of mid-thigh and hip
Time Frame: Baseline and 3 months
|
Baseline and 3 months
|
Quantitative MG Scale
Time Frame: Baseline and 3 months
|
Baseline and 3 months
|
Pulmonary function tests - FVC and maximal inspiratory and expiratory pressure
Time Frame: Baseline and 3 months
|
Baseline and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Charlene E Hafer-Macko, MD, Baltimore VA Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
January 12, 2010
First Submitted That Met QC Criteria
January 12, 2010
First Posted (Estimate)
January 13, 2010
Study Record Updates
Last Update Posted (Estimate)
November 1, 2016
Last Update Submitted That Met QC Criteria
October 28, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Neoplasms
- Autoimmune Diseases of the Nervous System
- Autoimmune Diseases
- Neoplasms by Site
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Neuromuscular Manifestations
- Nervous System Neoplasms
- Paraneoplastic Syndromes, Nervous System
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Muscle Weakness
- Myasthenia Gravis
Other Study ID Numbers
- Myasthenia and Exercise
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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