Multi-modal Exercise Program for Chronic Stable Myasthenia Gravis
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cardiovascular Fitness, Economy of Gait, Physiologic Reserve
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable generalized myasthenia gravis
- •adults age 18-70
排除标准
- •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
研究组 & 干预措施
exercise
Multimodal exercises that include walking, breathing exercises, dynamic balance, and core strengthening.
干预措施: Exercise (Other)
结局指标
主要结局
Cardiovascular Fitness, Economy of Gait, Physiologic Reserve
时间窗: Baseline and 3 months
次要结局
- Muscle strength by dynamometer(Baseline and 3 month)
- Quantitative MG Scale(Baseline and 3 months)
- Ambulatory function (6 minute walk, 5 day step activity and accelerometer data)(Baseline and 3 month)
- Cardiovascular risk profile (fasting glucose, oral glucose tolerance test, HbA1c, lipids), smoking status, and body mass index(Baseline and 3 months)
- Pulmonary function tests - FVC and maximal inspiratory and expiratory pressure(Baseline and 3 months)
- Myasthenia Quality of Life Scale, SF-36, and Visual Analogue Fatigue Scale(Baseline and 3 months)
- Body Composition by DEXA and CT of mid-thigh and hip(Baseline and 3 months)
研究者
Charlene Elaine Hafer-Macko
Myasthenia Gravis and Exercise
Baltimore VA Medical Center