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Exercise for Stable Myasthenia Gravis

B

Baltimore VA Medical Center

Status and phase

Unknown
Phase 1

Conditions

Myasthenia Gravis

Treatments

Other: Exercise

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01047761
Myasthenia and Exercise

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

exercise
Experimental group
Description:
Multimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening.
Treatment:
Other: Exercise

Trial contacts and locations

1

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Central trial contact

Charlene Hafer-Macko, MD

Data sourced from clinicaltrials.gov

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