Recruiting
Phase 1

Home Exercise Program

Sponsor:

Baltimore VA Medical Center

Code:

NCT01047761

Conditions

Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

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

Study ID

NCT01047761

Start date

Jan, 2010

Status verified date

Oct, 2016

Completion date

Dec, 2020

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: exercise

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

Interventions

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

Primary outcome measure

  • Cardiovascular Fitness, Economy of Gait, Physiologic Reserve [ Time Frame: Baseline and 3 months ]

Central Contacts and Locations

Central contacts

Charlene Hafer-Macko, MD

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

Locations

University of Maryland and Baltimore VA Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator:

Charlene Hafer-Macko, MD

More Information

Sponsor

Baltimore VA Medical Center

Last update posted

Nov 1, 2016

Last verified

Oct, 2016

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baltimore VA Medical Center on 2016-11-01.