Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis

Обзор

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.

Вмешательства

• Поведенческое Light Intensity Exercise
  12 weeks light intensity strength and endurance NeuroWell exercise program, specifically developed for individuals with neurological disorders or injuries. Participants have the intensity goals descripted in the experimental arm.
• Поведенческое Moderate Intensity Exercise
  12 weeks moderate intensity strength and endurance NeuroWell exercise program, specifically developed for individuals with neurological disorders or injuries. Participants have the intensity goals descripted in the experimental arm.

Первичные конечные точки

• Feasibility of light and moderate intensity exercise [Срок оценки: 12 weeks]
• Acceptability of light and moderate intensity exercise [Срок оценки: 12 weeks]
• Tolerability of light and moderate intensity exercise [Срок оценки: 12 weeks]

Вторичные конечные точки (4)

• Cardiovascular Test - 6-minute walk test [Срок оценки: 12 weeks]
• Cardiovascular and Strength test [Срок оценки: 12 weeks]
• Strength Test - 1-RM Upper Limb [Срок оценки: 12 weeks]
• Strength Test - 1-RM Lower Limb [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• HealthPartners Neuroscience Center — Saint Paul

Идентификаторы

NCT: NCT06491238 · A24-169

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗