Heart Failure (HF)NCT06876441
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 study testing HDTC training program in people with Heart Failure (HF), run by The Hong Kong Polytechnic University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure (HF)
- What is being tested?
- HDTC training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Yao Jie Xie, PhD, 34003798 ext. 852, grace.yj.xie@polyu.edu.hk
Yao Jie Xie, PhD
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Heart Failure (HF)
- Being tested
- HDTC training program, Usual Care Group
- Keywords
- heart failure, Tai Chi, dyadic, cardiac function, care burden
- Medical subject headings
- Heart Failure, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDTC training programBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: HDTC training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: From enrollment to the end of intervention at 4 weeks and 12 weeks
Secondary outcomes (9)
sedentary behavior of CHF individuals
CHF individuals' sedentary behavior will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Measured: From enrollment to the end of intervention at 4 and 12 weeks
Fear of Activity of CHF individuals
Fear of Activity in Patients with Chronic Heart Failure (Fact-CHF) will be used to assess HF patients' fear of exercise. This scale consists of 15 items, using a 5-point Likert scale where 0 represents 'never' and 4 represents 'always'. The total score ranges from 0 to 60, with higher scores indicating higher levels of fear.
Measured: From enrollment to the end of intervention at 4 and 12 weeks
Exercise self-efficacy of CHF individuals
Exercise self-efficacy will be assessed utilizing the Self-Efficacy for Exercise Scale (SEE) , which specifically measures an individual's confidence in performing exercise despite various barriers. The scale consists of 9 items with scores ranging from 0 to 90, with higher score indicating greater confidence in participating in exercise activities.
Measured: From enrollment to the end of intervention at 4 and 12 weeks
hospital admission of CHF individuals
CHF individual's hospital admission status will be presented based on the number of hospital admissions during the intervention period, including emergency visits.
Measured: From enrollment to the end of intervention at 12 weeks
Health-related QoL of CHF individuals
Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a specific and commonly used scale for measuring QoL among HF patients, which will be used to assess QoL.
Measured: From enrollment to the end of intervention at 4 and12 weeks
care burden of caregivers
The Chinese version of the Zarit Caregiver Burden Interview (ZBI), will be used to measure caregivers' perceived burden of providing care.
Measured: From enrollment to the end of intervention at 4 and 12 weeks
QoL of caregivers
The Family Caregiver Quality of Life (FAMQOL) is a specific instrument designed by Nauser in 2011 to assess the QoL among caregivers of HF patients.
Measured: From enrollment to the end of intervention at 4 and 12 weeks
mutuality of CHF-caregiver dyads
Mutuality, is a dyadic-level variable influencing caregiver's contribution to CHF self-care, with a good relationship improving the dyadic health of both patients and caregivers. The Mutuality Scale (MS) will be used, containing 15 items categorized into four dimensions: love and affection, shared values, shared enjoyable activities, and reciprocity. Responses are rated using a 5-point Likert type (0=not at all, 4=quite a lot). The mean item score will be computed as the final score, ranging from 0 to 4, with a higher score denoting better mutuality.
Measured: From enrollment to the end of intervention at 4 and 12 weeks
depression, anxiety, and stress of CHF-caregiver dyads
The Depression Anxiety Stress Scales-21 (DASS-21) will be used to assess the severity of psychological distress about depression, anxiety, and stress over the preceding week of both CHF patients and their caregivers. Each of the three DASS-21 subscales contains 7 items, with a total of 21 items. A Likert scale ranging from 0 to 3 is employed, with recommended cut-off scores of 9, 7, and 14 for depression, anxiety, and stress, respectively. The higher the score, the higher the level of anxiety, depression, and stress.
Measured: From enrollment to the end of intervention at 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Apr 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure (HF)Studies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University
- Responsible party
- Principal investigator, XIE Yao Jie Grace, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876441
- Sponsor's protocol ID
- HSEARS20240904005
- Status last verified
- Nov 2025
- First submitted
- 10 Mar 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Ngai FW, Wei L, Lu X, Liang J, Xie YJ. Effects of home-based digital-assisted dyadic Tai Chi training in Chinese chronic heart failure patients and family caregivers: a randomised controlled trial protocol. BMJ Open. 2026 Apr 28;16(4):e114352. doi: 10.1136/bmjopen-2025-114352.
PubMed 42049291
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06876441
- Acronym / sponsor ID
- HSEARS20240904005
- Conditions
- Heart Failure (HF)
- Keywords
- heart failure, Tai Chi, dyadic, cardiac function, care burden
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual Care GroupParticipants (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. |
| HDTC training program | Experimental | Behavioral: HDTC training programCHF 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- CHF individuals:
- caregivers:
Key exclusion criteria (7 listed)
- HF individuals:
- caregivers: · formal caregivers, such as nurses, will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDTC training programParticipants 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. | Behavioural | HDTC training program |
| Usual Care GroupCHF-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. | Other | Usual care |
Primary outcome
functional capacity of CHF individuals
Time frame: From enrollment to the end of intervention at 4 weeks and 12 weeks
The six-minute walking test (6MWT) will be used to assess exercise tolerance of CHF individuals (LVEF reduced or not)
cardiac function of CHF individuals
Time frame: From enrollment to the end of intervention at 4 weeks and 12 weeks
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.
9 secondary outcomes
sedentary behavior of CHF individuals
Time frame: From enrollment to the end of intervention at 4 and 12 weeks
Fear of Activity of CHF individuals
Time frame: From enrollment to the end of intervention at 4 and 12 weeks
Exercise self-efficacy of CHF individuals
Time frame: From enrollment to the end of intervention at 4 and 12 weeks
hospital admission of CHF individuals
Time frame: From enrollment to the end of intervention at 12 weeks
Health-related QoL of CHF individuals
Time frame: From enrollment to the end of intervention at 4 and12 weeks
care burden of caregivers
Time frame: From enrollment to the end of intervention at 4 and 12 weeks
QoL of caregivers
Time frame: From enrollment to the end of intervention at 4 and 12 weeks
mutuality of CHF-caregiver dyads
Time frame: From enrollment to the end of intervention at 4 and 12 weeks
depression, anxiety, and stress of CHF-caregiver dyads
Time frame: From enrollment to the end of intervention at 4 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Derived from this study: PubMed 42049291Zhang Y, Ngai FW, Wei L, Lu X, Liang J, Xie YJ. Effects of home-based digital-assisted dyadic Tai Chi training in Chinese chronic heart failure patients and family caregivers: a randomised controlled trial protocol. BMJ Open. 2026 Apr 28;16(4):e114352. doi: 10.1136/bmjopen-2025-114352.
- Individual participant dataSharing planned: No
Related trials for Heart Failure (HF)
Not yet recruitingPhase 3
MUTTON-HF Pilot Expansion
Heart Failure
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
Heart Failure, Heart Failure NYHA Class II
Active, not recruiting
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Left Ventricular Ejection Fraction, Heart Failure (HF)
RecruitingPhase 3
Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
Heart Failure, Heart Failure With Reduced Ejection Fraction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HDTC training program in people with Heart Failure (HF), run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao Jie Xie, PhD (3400 3798 ext. 852, grace.yj.xie@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional capacity of CHF individuals (time frame: From enrollment to the end of intervention at 4 weeks and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06876441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.