Exercise for Stable Myasthenia Gravis

NCT ID: NCT01047761

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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

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Myasthenia Gravis

Keywords

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Myasthenia Gravis Exercise Fitness Body Composition Physical Activity Pulmonary Function Balance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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exercise

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

Group Type EXPERIMENTAL

Exercise

Intervention Type 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

Interventions

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Exercise

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland

OTHER

Sponsor Role collaborator

Baltimore VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Charlene Elaine Hafer-Macko

Myasthenia Gravis and Exercise

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charlene E Hafer-Macko, MD

Role: PRINCIPAL_INVESTIGATOR

Baltimore VA Medical Center

Locations

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University of Maryland and Baltimore VA Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Charlene Hafer-Macko, MD

Role: CONTACT

Phone: 410-328-3100

Email: [email protected]

Related Links

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http://www.myasthenia.org/

Myasthenia Gravis Foundation of America

http://www.umm.edu/mg/

University of Maryland Myasthenia Gravis Center

Other Identifiers

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Myasthenia and Exercise

Identifier Type: -

Identifier Source: org_study_id