Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
Study NCT ID:
NCT01047761
Status:
UNKNOWN
Last Update Posted:
2016-11-01
First Post:
2010-01-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise for Stable Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-28', 'studyFirstSubmitDate': '2010-01-12', 'studyFirstSubmitQcDate': '2010-01-12', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular Fitness, Economy of Gait, Physiologic Reserve', 'timeFrame': 'Baseline and 3 months'}], 'secondaryOutcomes': [{'measure': 'Ambulatory function (6 minute walk, 5 day step activity and accelerometer data)', 'timeFrame': 'Baseline and 3 month'}, {'measure': 'Muscle strength by dynamometer', 'timeFrame': 'Baseline and 3 month'}, {'measure': 'Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Cardiovascular risk profile (fasting glucose, oral glucose tolerance test, HbA1c, lipids), smoking status, and body mass index', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Body Composition by DEXA and CT of mid-thigh and hip', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Quantitative MG Scale', 'timeFrame': 'Baseline and 3 months'}, {'measure': 'Pulmonary function tests - FVC and maximal inspiratory and expiratory pressure', 'timeFrame': 'Baseline and 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myasthenia Gravis', 'Exercise', 'Fitness', 'Body Composition', 'Physical Activity', 'Pulmonary Function', 'Balance'], 'conditions': ['Myasthenia Gravis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.myasthenia.org/', 'label': 'Myasthenia Gravis Foundation of America'}, {'url': 'http://www.umm.edu/mg/', 'label': 'University of Maryland Myasthenia Gravis Center'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable generalized myasthenia gravis\n* adults age 18-70\n\nExclusion Criteria:\n\n* already performing regular exercise\n* unstable angina\n* recent (\\<3 month) myocardial infarction, stroke, hospitalization for major illness or major surgery\n* chronic pain or orthopedic condition restricting exercise\n* active cancer, excluding basal cell cancer\n* anemia (HCT \\<30)\n* pregnancy\n* myasthenia gravis exacerbation in past 3 months'}, 'identificationModule': {'nctId': 'NCT01047761', 'briefTitle': 'Exercise for Stable Myasthenia Gravis', 'organization': {'class': 'FED', 'fullName': 'Baltimore VA Medical Center'}, 'officialTitle': 'Multi-modal Exercise Program for Chronic Stable Myasthenia Gravis', 'orgStudyIdInfo': {'id': 'Myasthenia and Exercise'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exercise', 'description': 'Multimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening.', 'interventionNames': ['Other: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': '3 month exercise intervention, three days a week Progressive in duration - up to 1 hour daily; Progressive in intensity\n\nMulti-modal exercise program includes a) aerobic - walking, b) resistive training with therabands and core exercises, and c) breathing exercises', 'armGroupLabels': ['exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charlene Hafer-Macko, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Maryland and Baltimore VA Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Charlene Hafer-Macko, MD', 'role': 'CONTACT', 'email': 'cmacko@grecc.umaryland.edu', 'phone': '410-328-3100'}], 'overallOfficials': [{'name': 'Charlene E Hafer-Macko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baltimore VA Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baltimore VA Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'University of Maryland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Myasthenia Gravis and Exercise', 'investigatorFullName': 'Charlene Elaine Hafer-Macko', 'investigatorAffiliation': 'Baltimore VA Medical Center'}}}}