NCT06876441

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

A Randomized Controlled Trial to Evaluate the Effect of the Home-based Digital-assisted Dyadic Tai Chi (HDTC) Training Program Among Sedentary Individuals With Heart Failure (HF) and Their Caregivers.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The full scale RCT is a two-arm parallel, single-blinded randomized controlled trial. A total of 128 CHF individuals and 128 caregivers will be enrolled and allocated to the HDTC group and the control group in a 1:1 ratio. Participants in the control group will receive usual care. Those in the HDTC group will attend usual care plus the HDTC training program, including a 30-minute educational seminar, a 1-hour dyadic coaching session, a preliminary Tai Chi training session, and 12-week Tai Chi training. Data on functional capacity, cardiac function, exercise self-efficacy, fear of activity, sedentary behavior, hospital admission, health-related quality of life, depression, anxiety, stress, and mutuality for HF individuals, as well as care burden, quality of life, depression, anxiety, stress, and mutuality of caregivers, will be collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) after the intervention. The intention-to-treat analysis (ITT), modified ITT analysis, and per-protocol analysis will be conducted. The generalized estimating equation (GEE) model will be used to measure changes in outcome variables.

Conditions

• Heart Failure (HF)

Interventions

Type	Name	Description
BEHAVIORAL	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.
OTHER	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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-03-14
• Last updated: 2026-03-11

Locations

1 site across 1 country: China