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临床试验/NCT05778747
NCT05778747已完成不适用

Feasibility of the Heart to Heart Yoga Program in Patients With Heart Failure and Caregivers

Misook L. Chung2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
Interleukin 6

研究概览

简要总结

A two-group (intervention vs. usual care), randomized controlled design will be used to determine the feasibility and acceptability of the intervention, the Heart2Heart program, and determine efficacy on physical and psychological outcomes in patients with heart failure (HF) and caregivers. A total of 20 patients with HF and 20 caregivers (n= 40) will be randomly assigned to the intervention or usual care group stratified by patient and caregiver groups. Only participants in the intervention will be asked to attend the 12-week sessions (two sessions per week; a total of 24 sessions in 12 weeks) via video conferencing (i.e., ZOOM). The short-term intervention efficacy will be assessed following week of the completion of 12-weeks sessions. Primary psychological outcomes include depressive symptoms, anxiety, stress, and quality of life. Primary physical outcomes include physical activity level, sleep quality, and perceived symptoms.

详细描述

Heart2Heart Intervention. In this study, the Heart to Heart Yoga intervention is a therapeutic and standardized form of yoga intervention that is adapted from MediYoga designed to fit the needs of patients with heart failure (HF) and family caregivers who may have physical limitations and to fit cultural and social norms in Kentucky. The Heart to Heart Yoga intervention key personnel include two primary investigators, two professional yoga instructors, and one PhD student who are all nurses and were certified Medi-Yoga instructor Level 1 by completing more than 120 hours of Medi-yoga training course for medical professionals. The intervention will use a gradual, physical/ psychological yoga adaptation approach, and it will be delivered two times per week (40 -60 minutes per session) via videoconference technology for 12 weeks (total 24 sessions). Real-time, face-to-face, video conferencing technology is used. In the recent systematic literature review, yoga has been delivered for 12 weeks in patients with HF. The the12-week duration was selected in this study by considering variations of individual adaptation and available evidence in the literature. Yoga sessions will be delivered by two registered nurses who were yoga instructors and certified MediYoga instructors.

The 12-weeks of intervention include three structured sessions. At each session, the first part will focus on deep breathing (5- 11 minutes), followed by physical posture movement (3 -11 minutes), and then meditation (6 -11 minutes), based on the structured gradual adaptation program. Participants will be instructed to modify movements to ensure comfort and safety. For example, if a participant is more comfortable seated in a chair instead of the floor, the instructor will demonstrate exercise modification while ensuring target muscles are utilized. All sessions will be delivered as group sessions using a video-conferencing program on a digital multimedia device. Each week, three yoga sessions are available to allow participants flexibility in attendance. The intervention group also receives a short-video clip each week (up to 10 minutes) and recommend to follow to practice yoga for 10 minutes per day, and a total of 50 minutes per week while not attending sessions. Participants will record practice time in a Yoga log booklet.

The investigators will limit the number of participants up to 10 at each session by monitoring enrollment rates. Participants will also receive materials that include yoga poses guides and mats. Without explicit skill demonstration and training, the intervention group will receive the printed information and links to the AHA's Life's Simple 7 program.

Usual Care Group. Participants in the usual care group will also receive the printed information and links to the AHA's Life's Simple 7 program without explicit skills and training, including education and stress management. Stress management will be encouraged by watching and practicing yoga programs by providing a yoga mat.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • After obtaining the signed consent, we will screen depressive symptoms using the 9-items of the Patient Health Questionnaire (see the detailed process of screening depressive symptom criterion in the procedure) because we will target only patients and caregivers who experience at least mild depressive symptoms.
  • major clinical cognitive impairment (i.e., dementia, Alzheimer's disease, and severe stroke)
  • co-existing terminal illness (e.g., cancer)
  • major psychiatric disorder other than depression
  • referral for heart transplantation.

结局指标

主要结局

Interleukin 6

时间窗: 12 weeks

Physical activity

时间窗: 12 weeks

Sit and stand

Stress

时间窗: 12 weeks

Cohen's Perceived Stress Scale

Feasibility of Intervention

时间窗: 12 weeks

Intervention evaluations will include a Likert style questionnaire to assess feasibility. Open-ended questions and comments will be utilized to gather additional information on any barriers or facilitators of participation and completion. feasibility data will be collected by each group's recruitment and retention rates by tracking eligible and enrolled participants using the consort diagram. We will also track participants' attendance rates and total attendance time (minutes) by monitoring the recorded sessions for the intervention acceptability. We will also collect participants' intervention satisfaction, enjoyment of the session, willingness to engage in yoga at home, and difficulty following yoga instruction using an 11-point numeric analog scale (0= not at all,10= very much) each session. We will also collect the Treatment Acceptability Adherence Scale (TAAS) and the Client Satisfaction Questionnaire (CSQ).

C Reactive Protein

时间窗: 12 weeks

Depressive Symptoms

时间窗: 12 weeks

Patient Health Questionnaire-9 (PHQ-9)

Brain Derived Neurotrophic Factor

时间窗: 12 weeks

Anxiety

时间窗: 12 weeks

Hospital Anxiety and Depressive Symptoms Scale (HADS)

Sleep Quality

时间窗: 12 weeks

Pittsburgh Sleep Quality Index

Perceived Symptoms

时间窗: 12 weeks

Heart Failure Somatic Symptom Checklist

Caregiver Burden

时间窗: 12 weeks

Zarit Burden Interview (ZBI)

Quality of Life

时间窗: 12 weeks

European Quality of Life (EQ-5D)

次要结局

未报告次要终点

研究者

发起方
Misook L. Chung
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Misook L. Chung

Professor

University of Kentucky

研究点 (2)

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