Home-based Tai Chi program for heart failure patients and their caregivers
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.
This study is testing whether a home-based Tai Chi program can help heart failure patients feel better and make it easier for their caregivers to support them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Qingdao, Shandong) |
| Trial ID | NCT06876441 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a Home-based Digital-assisted Dyadic Tai Chi (HDTC) training program aimed at improving cardiac function in sedentary individuals with heart failure (HF) while also addressing the care burden on their caregivers. The study involves 118 HF patients and 118 caregivers, who will be randomly assigned to either the HDTC group, which includes Tai Chi training and educational sessions, or a control group receiving usual care. Outcomes such as cardiac function, exercise tolerance, and quality of life will be measured at baseline and after 4 and 12 weeks. The trial employs rigorous statistical analyses to assess the impact of the intervention on both patients and caregivers.
Who should consider this trial
Good fit: Ideal candidates include sedentary individuals aged 18 to 75 with mild to moderate heart failure who can independently practice Tai Chi.
Not a fit: Patients planning surgery within the next 6 months or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance cardiac function and quality of life for heart failure patients while alleviating caregiver stress.
How similar studies have performed: Previous studies have shown positive outcomes with Tai Chi interventions for heart failure, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Qingdao, Shandong
- The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Yao Jie Xie, PhD
- Email: grace.yj.xie@polyu.edu.hk
- Phone: 3400 3798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.