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

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Heart Failure (HF)

Treatments: Other: Usual Care Group; Behavioral: HDTC training program

Study type: Interventional

Funder types: Other

Identifiers

NCT06876441

HSEARS20240904005

Details and patient eligibility

About

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 feasible and acceptable, this full scale will then conducted based on the refined protocol. The full scale RCT 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.

Full 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-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 attend usual care plus 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

Usual care

Active Comparator group

Description:

Participants (HF individuals and their caregivers) in this arm will receive a 30-min online comprehensive education and nurse-led support through telephone consultations in the aspects of symptom management, medication, dietary and exercise suggestions, psychosocial support, and regular monthly follow-up.

Treatment:

Other: Usual Care Group

HDTC training program

Experimental group

Description:

HF individual and caregiver dyads in the HDTC group will receive the usual care and also the HDTC training program, including a 30-minute educational seminar, a 1-hour dyadic coaching session, and 12-week Tai Chi training. The 24-form Yang-style Tai Chi will be adopted.

Treatment:

Behavioral: HDTC training program