Myasthenia GravisPhase 1NCT01047761
Exercise for Stable Myasthenia Gravis
A Phase 1 study testing Exercise in people with Myasthenia Gravis, run by Baltimore VA Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable generalized myasthenia gravis
- adults age 18-70
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Maryland and Baltimore VA Medical Center
Baltimore, Maryland, 21201
Charlene Hafer-Macko, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Myasthenia Gravis
- Being tested
- Exercise
- Keywords
- Myasthenia Gravis, Exercise, Fitness, Body Composition, Physical Activity, Pulmonary Function, Balance
- Medical subject headings
- Myasthenia Gravis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | Multimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Fitness, Economy of Gait, Physiologic Reserve
Measured: Baseline and 3 months
Secondary outcomes (7)
Ambulatory function (6 minute walk, 5 day step activity and accelerometer data)
Measured: Baseline and 3 month
Muscle strength by dynamometer
Measured: Baseline and 3 month
Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale
Measured: Baseline and 3 months
Cardiovascular risk profile (fasting glucose, oral glucose tolerance test, HbA1c, lipids), smoking status, and body mass index
Measured: Baseline and 3 months
Body Composition by DEXA and CT of mid-thigh and hip
Measured: Baseline and 3 months
Quantitative MG Scale
Measured: Baseline and 3 months
Pulmonary function tests - FVC and maximal inspiratory and expiratory pressure
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland
- Responsible party
- Principal investigator, Charlene Elaine Hafer-Macko, Baltimore VA Medical Center
- Investigators
- Charlene E Hafer-Macko, MD, Principal investigator, Baltimore VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047761
- Sponsor's protocol ID
- Myasthenia and Exercise
- Status last verified
- Oct 2016
- First submitted
- 12 Jan 2010
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modal Exercise Program for Chronic Stable Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT01047761
- Acronym / sponsor ID
- Myasthenia and Exercise
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, Exercise, Fitness, Body Composition, Physical Activity, Pulmonary Function, Balance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Collaborators
- University of Maryland
- Study start
- Jan 2010
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Other: ExerciseMultimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable generalized myasthenia gravis
- adults age 18-70
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise3 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 | Other | exercise |
Primary outcome
Cardiovascular Fitness, Economy of Gait, Physiologic Reserve
Time frame: Baseline and 3 months
7 secondary outcomes
Ambulatory function (6 minute walk, 5 day step activity and accelerometer data)
Time frame: Baseline and 3 month
Muscle strength by dynamometer
Time frame: Baseline and 3 month
Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale
Time frame: 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
Body Composition by DEXA and CT of mid-thigh and hip
Time frame: Baseline and 3 months
Quantitative MG Scale
Time frame: Baseline and 3 months
Pulmonary function tests - FVC and maximal inspiratory and expiratory pressure
Time frame: Baseline and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Myasthenia Gravis Foundation of AmericaLink provided by the sponsor.
- University of Maryland Myasthenia Gravis CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlene E Hafer-Macko, MD principal investigator
Baltimore VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise in people with Myasthenia Gravis, run by Baltimore VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlene Hafer-Macko, MD (410-328-3100, cmacko@grecc.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Fitness, Economy of Gait, Physiologic Reserve (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016; AzTrials last refreshed its copy on 27 Oct 2026.