Clinical trial NCT06876441: 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
Official title: A Randomized Controlled Trial to Evaluate the Effect of the Home-based Digital-assisted Dyadic Tai Chi (HDTC) Training Program on Cardiac Function Among Sedentary Individuals With Heart Failure (HF) and Care Burden of Their Caregivers.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure (HF)
Keywords: heart failure
Tai Chi
dyadic
cardiac function
care burden
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of Qingdao University
First posted: 2025-03-14
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: cardiac function of HF individuals
timeFrame: From enrollment to the end of intervention at 12 weeks
Secondary outcomes:
measure: exercise tolerance of HF individuals
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: sedentary behavior of HF individuals
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: hospital admission of HF individuals
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Health-related QoL of HF individuals
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: care burden of caregivers
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: QoL of caregivers
timeFrame: From enrollment to the end of intervention at 12 weeks
Other outcomes:
measure: Exercise self-efficacy of HF individuals
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: Fear of Activity of HF individuals
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: mutuality of HF-caregiver dyads
timeFrame: From enrollment to the end of intervention at 12 weeks
measure: depression, anxiety, and stress of HF-caregiver dyads
timeFrame: From enrollment to the end of intervention at 12 weeks
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References: