Exercise for Stable Myasthenia Gravis

October 28, 2016 updated by: Charlene Elaine Hafer-Macko, Baltimore VA Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland and Baltimore VA Medical Center
        • Principal Investigator:
          • Charlene Hafer-Macko, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exercise
Multimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular Fitness, Economy of Gait, Physiologic Reserve
Time Frame: Baseline and 3 months
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Ambulatory function (6 minute walk, 5 day step activity and accelerometer data)
Time Frame: Baseline and 3 month
Baseline and 3 month
Muscle strength by dynamometer
Time Frame: Baseline and 3 month
Baseline and 3 month
Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale
Time Frame: Baseline and 3 months
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
Baseline and 3 months
Body Composition by DEXA and CT of mid-thigh and hip
Time Frame: Baseline and 3 months
Baseline and 3 months
Quantitative MG Scale
Time Frame: Baseline and 3 months
Baseline and 3 months
Pulmonary function tests - FVC and maximal inspiratory and expiratory pressure
Time Frame: Baseline and 3 months
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baltimore VA Medical Center

Collaborators

University of Maryland

Investigators

  • Principal Investigator: Charlene E Hafer-Macko, MD, Baltimore VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Myasthenia and Exercise

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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