Effect of the Home-based Digital-assisted Dyadic Tai Chi (HDTC) Training Program Among Sedentary Individuals With HF and Their Caregivers: a Randomized Controlled Trial

NCT06876441 · tracked via the Priya Life Science China tracker

Sponsor

The Hong Kong Polytechnic University

Phase

Not applicable

Started

2025-04-01

Last updated

2026-03-11

Condition(s) studied

Heart Failure (HF)

Investigational drug(s) / intervention(s)

HDTC training programUsual Care Group

HDTC training program: Participants 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: CHF-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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * CHF individuals: * 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) * stable phase of disease in the past four weeks and capable of independently practice Tai Chi without any musculoskeletal disorders that may impede joint movement * sit more than 8 h/d in the past month * own a smartphone * volunteer to participate and provide informed consent. * caregivers: * age ≥18 years old * primary caregiver at home, who has emotional ties or social obligations with CHF individuals and provides daily care * able to exercise Tai Chi without help * volunteer to participate and provide informed consent. Exclusion Criteria: * HF individuals: * 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) * currently participate in similar or related studies. * caregivers: · formal caregivers, such as nurses, will be excluded.

Primary outcome measure(s)

functional capacity of CHF individuals — From enrollment to the end of intervention at 4 weeks and 12 weeks
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 — From enrollment to the end of intervention at 4 weeks and 12 weeks
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.

Trial sites (1)

Facility	City	Region	Status
The Affiliated Hospital of Qingdao University	Qingdao	Shandong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06876441 on ClinicalTrials.gov ↗ ← All trials in China