Status:
RECRUITING
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
Lead Sponsor:
The Hong Kong Polytechnic University
Collaborating Sponsors:
The Affiliated Hospital of Qingdao University
Conditions:
Heart Failure (HF)
Eligibility:
All Genders
18-75 years
Phase:
NA
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 feasibl...
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-bl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT06876441
Start Date
April 1 2025
End Date
April 1 2026
Last Update
November 19 2025
Active Locations (1)
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1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000