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.

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.

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.

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.