A Pilot and Feasibility Study of a Yoga Intervention in Heart Failure Patients With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Brain structure
研究概览
简要总结
Mild cognitive impairment is highly prevalent in patients with heart failure and results in poor well-being and quality of life. While yoga has proven effective in promoting cognitive health in older adults through its gentle movements, controlled breathing, and meditation, its effects on patients with heart failure remain unknown. Therefore, this feasibility and pilot study plans to deliver a 12-week yoga intervention and test its effects on cognitive function in patients with heart failure and mild cognitive impairment.
详细描述
A prospective, 2-arm comparative feasibility design will be used. The investigators will enroll 24 patients with a confirmed heart failure diagnosis with mild cognitive impairment. Patients will be randomized equally into yoga intervention or control group. Patients in the yoga intervention group will receive a 60-minute yoga session twice per week for 12-week. Survey, cognitive function data, MRI scans, and blood samples will be collected at baseline and at 3 months (after completion of yoga intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 55 years and older
- •Confirmed heart failure diagnosis with mild cognitive impairment
- •New York Heart Association functional class II-IV
排除标准
- •Co-existing neurological disorders, traumatic brain injury, psychiatric disorders, or terminal illnesses
- •Have implanted defibrillator, left ventricular assist device placement or cardiac transplant
- •Have any other implanted metals that interfere with the MRI magnetic field for patient safety
- •Substance abuse
- •Unable to perform yoga due to physical limitations or severity of illness
研究组 & 干预措施
Yoga intervention
干预措施: Yoga intervention (Behavioral)
Control condition
干预措施: Control condition (Behavioral)
结局指标
主要结局
Brain structure
时间窗: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
Using structural magnetic resonance imaging to examine brain structure between intervention and control groups. Less brain alteration is optimal.
Brain functional connectivity
时间窗: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
Functional magnetic resonance imaging is used to examine functional connectivity between intervention and control groups. A balance of activity across different brain regions is optimal.
Serum brain-derived neurotrophic factor
时间窗: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
A blood sample will be obtained using phlebotomy to measure the levels of serum brain-derived neurotrophic factor and reported in pg/mL. Higher concentrations are optimal.
Cognitive function
时间窗: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
Using cognitive tests to examine cognitive function and performance between intervention and control groups. A higher score on cognitive tests indicates better cognitive function.
次要结局
未报告次要终点
研究者
Chin-Yen Lin
Assistant Professor
Auburn University