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

NCT ID: NCT06876441

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-04-30

Brief Summary

Firstly, we will conduct a pilot RCT before this full scale RCT to assess the feasibility, acceptability, and preliminary efficacy of the HDTC training program. If the HDTC training program is feasible and acceptable, this full scale will then conducted based on the refined protocol. The full scale RCT aims to assess the effectiveness of the HDTC training program in improving cardiac function and secondary outcomes among sedentary heart failure individuals, while simultaneously reducing care burden and improving other outcomes for their caregivers.

Detailed Description

The pilot part is a two-arm parallel, single-blinded randomized controlled trial. 20 HF dyads will be enrolled and attend the 12 weeks intervention. The full scale RCT is a two-arm parallel, single-blinded randomized controlled trial. A total of 118 HF individuals and 118 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, and 12-week Tai Chi training. Data on cardiac function, exercise tolerance, 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Usual care

Participants (HF individuals and their caregivers) in this arm will receive 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.

Group Type: ACTIVE_COMPARATOR

Usual Care Group

Intervention Type: OTHER

HF-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.

HDTC training program

HF individual and caregiver dyads in the HDTC group will receive the usual care and also the HDTC training program, including a 30-minute educational seminar, a 1-hour dyadic coaching session, and 12-week Tai Chi training. The 24-form Yang-style Tai Chi will be adopted.

Group Type: EXPERIMENTAL

HDTC training program

Intervention Type: BEHAVIORAL

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 once a week and follow instructional videos twice a week, with each session lasting 50 minutes. The finalized contents will be determined based on the pilot RCT.

Interventions

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 once a week and follow instructional videos twice a week, with each session lasting 50 minutes. The finalized contents will be determined based on the pilot RCT.

Intervention Type: BEHAVIORAL

Usual Care Group

HF-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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• HF individuals:

• aged 18 to 75 years
• diagnosed with CHF based on the Chinese Guidelines for Diagnosis and Treatment of Heart Failure 2024
• 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 HF 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

XIE Yao Jie Grace

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yao Jie Xie, PhD

Role: CONTACT

grace.yj.xie@polyu.edu.hk

3400 3798 ext. 852

Yan Zhang, Master

Role: CONTACT

23037811r@connect.polyu.hk

67083645 ext. 852

Facility Contacts

Yao Jie Xie, PhD

Role: primary

grace.yj.xie@polyu.edu.hk

34003798 ext. 852

Other Identifiers

HSEARS20240904005

Identifier Type: -

Identifier Source: org_study_id