Engaging Stakeholders and Patients to Evaluate the Feasibility of Yoga to Improve Cognitive Function in Rural Heart Failure Patients in the Deep South
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
- Perceptions and experiences of yoga practice measured by the Essential Properties of Yoga Questionnaire.
研究概览
简要总结
The investigators will conduct a two-phase pilot study to test the feasibility and acceptability of a 12-week Chair Yoga intervention for 20 heart-failure patients. Using a patient-centered approach, investigators will involve stakeholders in designing the protocol, gather patient feedback, and refine the protocol accordingly.
详细描述
The aims of this study include:
Phase 1: Engaging stakeholders and patients to develop the initial study protocol.
- Engage stakeholders and patients to develop the initial study protocol.
- Recruit the first 10 patients to complete a 12-week online yoga intervention and collect data before and after the yoga intervention.
- Evaluate the feasibility of yoga intervention and revise the initial study protocol with stakeholders based on the data collected from the patients.
Phase 2: Pilot the revised protocol and finalize plans.
- Implement the revised study protocol for the next 10 patients, deliver a 12-week online yoga intervention, and collect data before and after the yoga intervention.
- Evaluate the pilot results on the feasibility of yoga intervention to enhance patient-centered outcomes and cognitive function based on the data collected from the patients.
- Finalize the study protocol with stakeholders and disseminate findings with communities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure diagnosis
- •Aged 55 years or older
排除标准
- •Traumatic brain injury, co-existing neurological and psychiatric disorders
- •Implanted defibrillator or metal objects, left ventricular assist device placement, or cardiac transplant
- •Substance abuse
- •Unable to perform yoga due to physical limitations or severity of illness
- •Currently engaged in a yoga program
结局指标
主要结局
Perceptions and experiences of yoga practice measured by the Essential Properties of Yoga Questionnaire.
时间窗: After completion of 12-week intervention.
Rated on Likert scales from 0 (not at all) to 4 (a very large amount).
Cognitive function measured by the Montreal Cognitive Assessment.
时间窗: Baseline
Score ≥26: generally normal (context-dependent); 18-25: mild impairment range; \<18: more likely moderate-severe impairment.
次要结局
- Health-related quality of life measured by the Minnesota Living with Heart Failure Questionnaire.(Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention.)
- Social factors of health measured by the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences.(Baseline)
研究者
Chin-Yen Lin
Assistant Professor
Auburn University