Exercise for Stable Myasthenia Gravis
Primary Purpose
Myasthenia Gravis
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Myasthenia Gravis focused on measuring Myasthenia Gravis, Exercise, Fitness, Body Composition, Physical Activity, Pulmonary Function, Balance
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
Sites / Locations
- University of Maryland and Baltimore VA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
exercise
Arm Description
Multimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening.
Outcomes
Primary Outcome Measures
Cardiovascular Fitness, Economy of Gait, Physiologic Reserve
Secondary Outcome Measures
Ambulatory function (6 minute walk, 5 day step activity and accelerometer data)
Muscle strength by dynamometer
Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale
Cardiovascular risk profile (fasting glucose, oral glucose tolerance test, HbA1c, lipids), smoking status, and body mass index
Body Composition by DEXA and CT of mid-thigh and hip
Quantitative MG Scale
Pulmonary function tests - FVC and maximal inspiratory and expiratory pressure
Full Information
NCT ID
NCT01047761
First Posted
January 12, 2010
Last Updated
October 28, 2016
Sponsor
Baltimore VA Medical Center
Collaborators
University of Maryland
1. Study Identification
Unique Protocol Identification Number
NCT01047761
Brief Title
Exercise for Stable Myasthenia Gravis
Official Title
Multi-modal Exercise Program for Chronic Stable Myasthenia Gravis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baltimore VA Medical Center
Collaborators
University of Maryland
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myasthenia Gravis
Keywords
Myasthenia Gravis, Exercise, Fitness, Body Composition, Physical Activity, Pulmonary Function, Balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exercise
Arm Type
Experimental
Arm Description
Multimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Cardiovascular Fitness, Economy of Gait, Physiologic Reserve
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Ambulatory function (6 minute walk, 5 day step activity and accelerometer data)
Time Frame
Baseline and 3 month
Title
Muscle strength by dynamometer
Time Frame
Baseline and 3 month
Title
Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale
Time Frame
Baseline and 3 months
Title
Cardiovascular risk profile (fasting glucose, oral glucose tolerance test, HbA1c, lipids), smoking status, and body mass index
Time Frame
Baseline and 3 months
Title
Body Composition by DEXA and CT of mid-thigh and hip
Time Frame
Baseline and 3 months
Title
Quantitative MG Scale
Time Frame
Baseline and 3 months
Title
Pulmonary function tests - FVC and maximal inspiratory and expiratory pressure
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlene Hafer-Macko, MD
Phone
410-328-3100
Email
cmacko@grecc.umaryland.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlene E Hafer-Macko, MD
Organizational Affiliation
Baltimore VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland and Baltimore VA Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlene Hafer-Macko, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.myasthenia.org/
Description
Myasthenia Gravis Foundation of America
URL
http://www.umm.edu/mg/
Description
University of Maryland Myasthenia Gravis Center
Learn more about this trial
Exercise for Stable Myasthenia Gravis
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