Aortic StenosisNCT06418555
Construction and Application Plan of Home Cardiac Rehabilitation for Patients Undergoing TAVR
A study testing A home rehabilitation program centered on exercise in people with Aortic Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Cardiac rehabilitation is a long-term process, but patients have poor compliance with cardiac rehabilitation. The theory of behavior change rotation aims to comprehensively intervene from three aspects: ability, opportunity, and motivation, promoting individual behavior change by selecting the best intervention… Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- A home rehabilitation program centered on exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2024to 10 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Patients undergoing TAVR who were classified as Grade I-III by the New York Heart Association (NYHA); Patients are able to use mobile devices such as smartphones; Patients who have obtained admission qualifications after undergoing digital home cardiac rehabilitation risk assessment by the rehabilitation team; The patient and their family members voluntarily participate in this study and are willing to provide an informed consent form; Able to use remote rehabilitation diagnosis and treatment systems Exclusion Criteria: Malignant tumors or those with serious complications; Patients with hearing and visual impairments; Patients with limited physical activity due to other diseases; Patients with obvious cognitive or mental disorders; Patients without Internet connection after returning home from hospital; Patients who have participated in or participated in other trials or rehabilitation plans within the past three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Digital Home-based Cardiac Rehabilitation Program for TAVR Patients Based: a Randomized Controlled Trial
Cardiac rehabilitation is a long-term process, but patients have poor compliance with cardiac rehabilitation. The theory of behavior change rotation aims to comprehensively intervene from three aspects: ability, opportunity, and motivation, promoting individual behavior change by selecting the best intervention function and maximizing the use of available resources. To improve the compliance of TAVR patients with digital home cardiac rehabilitation, this study is based on the needs of TAVR patients and their caregivers for digital home cardiac rehabilitation. Based on the best evidence summary of TAVR patients' home cardiac rehabilitation, a home cardiac rehabilitation plan for TAVR patients is constructed using the theory of behavior change wheels. The Delphi method is used to revise the plan, develop a TAVR patient home cardiac rehabilitation management system, and conduct clinical application research on the plan to explore the intervention effect of TAVR patients' home cardiac rehabilitation based on real-time information intervention.
Read the detailed description
Conduct home cardiac rehabilitation assessment 1-6 days before discharge; In the first week after discharge, cultivate the patient's motivation for rehabilitation; In the second week after discharge, create a home rehabilitation environment; In the third week after discharge, health education on risk factor management; Health education on anticoagulation management in the fourth week after discharge; 5 weeks after discharge, home symptom and follow-up management education; Carry out home exercise and monitoring from 1 to 12 weeks after discharge.
- Conditions
- Aortic Stenosis
- Being tested
- A home rehabilitation program centered on exercise
- Keywords
- Cardiac Rehabilitation, Extended Care, Aortic Stenosis, TAVR
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A home rehabilitation program centered on exerciseBehavioural
Establish a multidisciplinary team, with team members combining clinical experience, summarizing the best evidence as the basis, and using the theory of behavior change wheels as the framework, to preliminarily construct a home-based cardiac rehabilitation plan suitable for TAVR patients in China's national conditions. Conduct expert consultation using the Delphi method to form the final version of the home cardiac rehabilitation plan for TAVR patients.
| Study group | Role | What they receive |
|---|---|---|
| Home Rehabilitation Team | Experimental | Adding an immediate information-based intervention to the routine home care intervention with a home cardiac rehabilitation program intervention for TAVR patients. Receives: Behavioral: A home rehabilitation program centered on exercise |
| Routine care group | Experimental | Routine care Receives: Behavioral: A home rehabilitation program centered on exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home-based cardiac rehabilitation exercise adherence
Measured at the time of the patient's follow-up visit to the clinic
Measured: After surgery, and 3 months after discharge
Secondary outcomes (4)
Modified Barthel Index
Measured at the time of the patient's follow-up visit to the clinic
Measured: After surgery, and 3 months after discharge
Minnesota Living with Heart Failure questionnaire
Measured at the time of the patient's follow-up visit to the clinic
Measured: After surgery, and 3 months after discharge
Tilburg Frailty Indicator
Measured at the time of the patient's follow-up visit to the clinic
Measured: After surgery, and 3 months after discharge
Postoperative related complications
Measured at the time of the patient's follow-up visit to the clinic
Measured: After surgery, and 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start18 Jan 2024
- Primary completion10 Aug 2024
- Study completion10 Aug 2024
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 Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingying Jia, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418555
- Sponsor's protocol ID
- 2023-0921
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jia YY, Dong MQ, Feng J, Hu JN, Hu HT, Yuan TM, Song JP. The effectiveness of a nurse-led home-based cardiac rehabilitation based on instant information intervention in the prognosis of patients with TAVR: A randomized controlled trial protocol. Curr Probl Cardiol. 2025 Mar;50(3):102967. doi: 10.1016/j.cpcardiol.2024.102967. Epub 2024 Dec 8.
PubMed 39657845
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Digital Home-based Cardiac Rehabilitation Program for TAVR Patients Based: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06418555
- Acronym / sponsor ID
- 2023-0921
- Conditions
- Aortic Stenosis
- Keywords
- Cardiac Rehabilitation, Extended Care, Aortic Stenosis, TAVR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 17 May 2024 (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.
Cardiac rehabilitation is a long-term process, but patients have poor compliance with cardiac rehabilitation. The theory of behavior change rotation aims to comprehensively intervene from three aspects: ability, opportunity, and motivation, promoting individual behavior change by selecting the best intervention function and maximizing the use of available resources. To improve the compliance of TAVR patients with digital home cardiac rehabilitation, this study is based on the needs of TAVR patients and their caregivers for digital home cardiac rehabilitation. Based on the best evidence summary of TAVR patients' home cardiac rehabilitation, a home cardiac rehabilitation plan for TAVR patients is constructed using the theory of behavior change wheels. The Delphi method is used to revise the plan, develop a TAVR patient home cardiac rehabilitation management system, and conduct clinical application research on the plan to explore the intervention effect of TAVR patients' home cardiac rehabilitation based on real-time information intervention.
Detailed description
Conduct home cardiac rehabilitation assessment 1-6 days before discharge; In the first week after discharge, cultivate the patient's motivation for rehabilitation; In the second week after discharge, create a home rehabilitation environment; In the third week after discharge, health education on risk factor management; Health education on anticoagulation management in the fourth week after discharge; 5 weeks after discharge, home symptom and follow-up management education; Carry out home exercise and monitoring from 1 to 12 weeks after discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Rehabilitation Team | Experimental | Behavioral: A home rehabilitation program centered on exerciseAdding an immediate information-based intervention to the routine home care intervention with a home cardiac rehabilitation program intervention for TAVR patients. |
| Routine care group | Experimental | Behavioral: A home rehabilitation program centered on exerciseRoutine care |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| A home rehabilitation program centered on exerciseEstablish a multidisciplinary team, with team members combining clinical experience, summarizing the best evidence as the basis, and using the theory of behavior change wheels as the framework, to preliminarily construct a home-based cardiac rehabilitation plan suitable for TAVR patients in China's national conditions. Conduct expert consultation using the Delphi method to form the final version of the home cardiac rehabilitation plan for TAVR patients. | Behavioural | Home Rehabilitation Team, Routine care group |
Primary outcome
Home-based cardiac rehabilitation exercise adherence
Time frame: After surgery, and 3 months after discharge
Measured at the time of the patient's follow-up visit to the clinic
4 secondary outcomes
Modified Barthel Index
Time frame: After surgery, and 3 months after discharge
Minnesota Living with Heart Failure questionnaire
Time frame: After surgery, and 3 months after discharge
Tilburg Frailty Indicator
Time frame: After surgery, and 3 months after discharge
Postoperative related complications
Time frame: After surgery, and 3 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Derived from this study: PubMed 39657845Jia YY, Dong MQ, Feng J, Hu JN, Hu HT, Yuan TM, Song JP. The effectiveness of a nurse-led home-based cardiac rehabilitation based on instant information intervention in the prognosis of patients with TAVR: A randomized controlled trial protocol. Curr Probl Cardiol. 2025 Mar;50(3):102967. doi: 10.1016/j.cpcardiol.2024.102967. Epub 2024 Dec 8.
- Individual participant dataSharing planned: No
Related trials for Aortic Stenosis
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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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. This study is not recruiting at the moment.
Yingying Jia study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A home rehabilitation program centered on exercise in people with Aortic Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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?
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: finished, as of the sponsor's last update on 24 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home-based cardiac rehabilitation exercise adherence (time frame: After surgery, and 3 months after discharge). 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 NCT06418555, 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 24 Feb 2025.