RecruitingNot ApplicableNCT06876441

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.


Sponsor

The Hong Kong Polytechnic University

Enrollment

256 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria14

  • 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
  • MWD \>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 Criteria7

  • 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.

Interventions

BEHAVIORALHDTC training program

Participants will receive usual care plus HDTC training program, including four parts: (1)30-minute educational seminar via WeChat: provide disease knowledge, propose strategies to replace sedentary behavior, and introduce Tai Chi. (2)1-hour online nurse-lead dyadic coaching session: introduce dyadic Tai Chi, clarify the roles and responsibilities, and establish a shared goal among dyads. (3)1-hour preliminary Tai Chi training session: face-to-face, introduce online Tai Chi learning, demonstrations on using heart rate monitor. (4)12-week Tai Chi training: Dyads learn Tai Chi following Tai Chi master online. The frequency gradually increased from 2 to 3 classes per week and duration extending from 30 to 50 minutes. Subsequently, they will practice Tai Chi with the master twice a week and slef-practce follow instructional videos once a week, with each session lasting 50 minutes.

OTHERUsual Care Group

CHF-caregiver dyads in the control group will receive the usual care, including 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 every month.


Locations(1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

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NCT06876441


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