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

Not Applicable

Recruiting

• Conditions: Heart Failure (HF)

• Registration Number: NCT06876441
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

The proposed study 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

This 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 also attend 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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-29
• Study Start: 2025-04
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 236

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
cardiac function of HF individuals	From enrollment to the end of intervention at 12 weeks	The primary outcome of this study is the cardiac function, measured by NT-proBNP and LVEF. NT-proBNP will be measured through blood test in the clinical laboratory of the Affiliated Hospital of Qingdao University. And the same assay kits will be used to ensure the test consistency and stability. LVEF is another 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.

Secondary Outcome Measures

Name	Time	Method
exercise tolerance of HF individuals	From enrollment to the end of intervention at 12 weeks	The 6MWT will be used to assess exercise tolerance.
sedentary behavior of HF individuals	From enrollment to the end of intervention at 12 weeks	HF individuals' sedentary behavior will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
hospital admission of HF individuals	From enrollment to the end of intervention at 12 weeks	The HF individual's hospital admission status will be presented based on the number of hospital admissions during the intervention period, including emergency visits.
Health-related QoL of HF individuals	From enrollment to the end of intervention at 12 weeks	Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a specific and commonly used scale for measuring QoL among HF patients, which will be used to assess QoL.
care burden of caregivers	From enrollment to the end of intervention at 12 weeks	The Chinese version of the Zarit Caregiver Burden Interview (ZBI), will be used to measure caregivers' perceived burden of providing care.
QoL of caregivers	From enrollment to the end of intervention at 12 weeks	The Family Caregiver Quality of Life (FAMQOL) is a specific instrument designed by Nauser in 2011 to assess the QoL among caregivers of HF patients.

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China