Exercise for Stable Myasthenia Gravis

NCT01047761 | Unknown Phase 1 DMC

• 1 other identifier: Myasthenia and Exercise
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Myasthenia Gravis

Keywords

Myasthenia Gravis; Exercise; Fitness; Body Composition; Physical Activity; Pulmonary Function; Balance

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Fitness, Economy of Gait, Physiologic Reserve

  Baseline and 3 months

Secondary Outcomes (7)

• Ambulatory function (6 minute walk, 5 day step activity and accelerometer data)

  Baseline and 3 month

• Muscle strength by dynamometer

  Baseline and 3 month

• Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale

  Baseline and 3 months

• Cardiovascular risk profile (fasting glucose, oral glucose tolerance test, HbA1c, lipids), smoking status, and body mass index

  Baseline and 3 months

• Body Composition by DEXA and CT of mid-thigh and hip

  Baseline and 3 months

Study Arms (1)

exercise

EXPERIMENTAL

Multimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening.

Other: Exercise

Interventions

Exercise OTHER

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

exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable generalized myasthenia gravis
• adults age 18-70

You may not qualify if:

• 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

Sponsors & Collaborators

• Baltimore VA Medical Center: lead
• University of Maryland: collaborator

Study Sites (1)

University of Maryland and Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Related Links

• Myasthenia Gravis Foundation of America
• University of Maryland Myasthenia Gravis Center

MeSH Terms

Conditions

Myasthenia Gravis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Charlene E Hafer-Macko, MD

  Baltimore VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlene Hafer-Macko, MD

CONTACT

410-328-3100; cmacko@grecc.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Myasthenia Gravis and Exercise

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

US (1)