NCT06876441

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 11, 2026

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

March 10, 2025

Last Update Submit

March 8, 2026

Conditions

Heart Failure (HF)

Keywords

heart failureTai Chidyadiccardiac functioncare burden

Outcome Measures

Primary Outcomes (2)

  • functional capacity of CHF individuals

    The six-minute walking test (6MWT) will be used to assess exercise tolerance of CHF individuals (LVEF reduced or not)

    From enrollment to the end of intervention at 4 weeks and 12 weeks

  • cardiac function of CHF individuals

    Another primary outcome of this study is the cardiac function of those CHF individuals with HFrEF and HFmrEF, measured by LVEF. LVEF is a crucial parameter for assessing cardiac function. It is an echocardiographic measure that reflects cardiac function by indicating the percentage of blood ejected from the left ventricle with each heartbeat. Three-dimensional echocardiography will be employed to measure LVEF.

    From enrollment to the end of intervention at 4 weeks and 12 weeks

Secondary Outcomes (9)

  • sedentary behavior of CHF individuals

    From enrollment to the end of intervention at 4 and 12 weeks

  • Fear of Activity of CHF individuals

    From enrollment to the end of intervention at 4 and 12 weeks

  • Exercise self-efficacy of CHF individuals

    From enrollment to the end of intervention at 4 and 12 weeks

  • hospital admission of CHF individuals

    From enrollment to the end of intervention at 12 weeks

  • Health-related QoL of CHF individuals

    From enrollment to the end of intervention at 4 and12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Participants (CHF 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.

Other: Usual Care Group

HDTC training program

EXPERIMENTAL

CHF 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, a preliminary Tai Chi training session, and 12-week Tai Chi training. The 24-form Yang-style Tai Chi will be adopted.

Behavioral: HDTC training program

Interventions

HDTC training programBEHAVIORAL

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.

HDTC training program
Usual Care GroupOTHER

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.

Usual care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Heart FailureCaregiver Burden

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Yao Jie Xie, PhD

CONTACT

3400 3798grace.yj.xie@polyu.edu.hk

Yan Zhang, Master

CONTACT

6708364523037811r@connect.polyu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

April 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

March 11, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)