Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of light and moderate intensity exercise
研究概览
简要总结
The overall purpose of this pilot study is to examine the feasibility, acceptability, and tolerability of light and moderate intensity exercise in adults with MGeffect of light vs. moderate intensity exercise on health outcomes. Participants will be enrolled into the NeuroWell exercise program, which is geared toward individuals with neurological disorders or injuries and led by Certified Exercise Physiologists (CEPs) at the HealthPartners Neuroscience Center. A total of 20 people with MG will be enrolled in this study and participate in a small group exercise program 3 times a week for 12 weeks. Participants will be randomized into two exercise groups: 1) Light intensity or 2) Moderate intensity. We hypothesize that light and moderate intensity exercise will be feasible, acceptable, and tolerable in adults with MG and that individuals in the light intensity exercise group will be able to achieve the same improvement in health outcomes as the moderate intensity group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide and provision of signed and dated informed consent form.
- •Age 18-80
- •Diagnosis of generalized MG.
- •On a stable MG prescription medication regimen for the last 3 months.
排除标准
- •Non-English speaking
- •Regular exercise participation within the month prior to study enrollment or any outside exercise participation during the study intervention period.
- •Significant cognitive impairment of any etiology that would impact study participation.
- •History of heart failure, chronic lung disease, angina or any other condition that causes unreasonable shortness of breath on exertion.
- •History of any serious neurological, psychiatric, or substance use disorders that would impact study participation.
- •Women who are currently pregnant or planning to become pregnant during the study.
- •Any other medical conditions that could affect their ability to participate in exercise for the study duration (as determined by study investigators).
- •Active participation or past participation ≤3 months in any other interventional research study.
- •Unwilling to participate in all study related activities.
结局指标
主要结局
Feasibility of light and moderate intensity exercise
时间窗: 12 weeks
Percent of participants recruited of potential participants contacted. Range: \[0-100\]. Higher percentage indicates higher feasibility
Acceptability of light and moderate intensity exercise
时间窗: 12 weeks
Percent of participants who complete the program of participants who start the program. Range: \[0-100\]. Higher percentage indicates higher acceptability
Tolerability of light and moderate intensity exercise
时间窗: 12 weeks
Percent of classes participants complete during the course of the program. Range: \[0-100\]. Higher percentage indicates higher tolerability.
次要结局
- Cardiovascular Test - 6-minute walk test(12 weeks)
- Cardiovascular and Strength test(12 weeks)
- Strength Test - 1-RM Upper Limb(12 weeks)
- Strength Test - 1-RM Lower Limb(12 weeks)