The full scale RCT aims to assess the effectiveness of the HDTC training program in improving functional capacity, cardiac function and secondary outcomes among sedentary chronic heart failure (CHF) individuals, while simultaneously reducing care burden and improving other outcomes for their caregivers.
aged 18 to 75 years
diagnosed with CHF, regardless of the HF phenotype (HFrEF, HFmrEF, and HFpEF)
categorized as NYHA class I, II or III
6MWD >150 meters (mild to moderate HF)
plan to undergo surgery within the next 6 months
have severe comorbidities, such as cancer, liver or kidney failure, or diagnosed psychiatric disorders
plan to be admitted to a nursing home or other care facilities
regularly practice Tai Chi or engaging in other forms of exercise in the past 3 months (at least 3 times per week, at least 20 minutes of regular exercise each time)
Parallel
HDTC training program
BehavioralParticipants will receive usual care plus HDTC training program, including four parts: (1)30-minute educational seminar via WeChat: provide disease knowledge, propose strategies to replace sedentary behavior, and introduce Tai Chi. (2)1-hour online nurse-lead dyadic coaching session: introduce dyadic Tai Chi, clarify the roles and responsibilities, and establish a shared goal among dyads. (3)1-hour preliminary Tai Chi training session: face-to-face, introduce online Tai Chi learning, demonstrations on using heart rate monitor. (4)12-week Tai Chi training: Dyads learn Tai Chi following Tai Chi master online. The frequency gradually increased from 2 to 3 classes per week and duration extending from 30 to 50 minutes. Subsequently, they will practice Tai Chi with the master twice a week and slef-practce follow instructional videos once a week, with each session lasting 50 minutes.
Usual Care Group
Other interventionCHF-caregiver dyads in the control group will receive the usual care, including a 30-min online comprehensive education and nurse-led support through telephone consultations in the aspects of symptom management, medication, dietary and exercise suggestions, psychosocial support, and regular monthly follow-up every month.
functional capacity of CHF individuals
The six-minute walking test (6MWT) will be used to assess exercise tolerance of CHF individuals (LVEF reduced or not)
cardiac function of CHF individuals
Another primary outcome of this study is the cardiac function of those CHF individuals with HFrEF and HFmrEF, measured by LVEF. LVEF is a crucial parameter for assessing cardiac function. It is an echocardiographic measure that reflects cardiac function by indicating the percentage of blood ejected from the left ventricle with each heartbeat. Three-dimensional echocardiography will be employed to measure LVEF.
sedentary behavior of CHF individuals
CHF individuals' sedentary behavior will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Fear of Activity of CHF individuals
Fear of Activity in Patients with Chronic Heart Failure (Fact-CHF) will be used to assess HF patients' fear of exercise. This scale consists of 15 items, using a 5-point Likert scale where 0 represents 'never' and 4 represents 'always'. The total score ranges from 0 to 60, with higher scores indicating higher levels of fear.
Exercise self-efficacy of CHF individuals
Exercise self-efficacy will be assessed utilizing the Self-Efficacy for Exercise Scale (SEE) , which specifically measures an individual's confidence in performing exercise despite various barriers. The scale consists of 9 items with scores ranging from 0 to 90, with higher score indicating greater confidence in participating in exercise activities.
hospital admission of CHF individuals
CHF individual's hospital admission status will be presented based on the number of hospital admissions during the intervention period, including emergency visits.
Click on the lead sponsor to view all of their trials.
The Hong Kong Polytechnic University
Lead sponsor
The Affiliated Hospital of Qingdao University
Collaborator
