Cardiac RehabilitationNCT05320848
Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease
A study testing cardiac rehabilitation in people with Cardiac Rehabilitation, run by Shenzhen People's Hospital at 1 site in China.
Trial summary
Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease. Current guidelines support its use in patients after acute coronary syndrome, coronary artery bypass grafting, coronary stent placement, valve surgery, and stable chronic systolic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 1 Feb 2025
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cardiovascular disease
Who cannot join
- Incalculable TFC
- Coronary artery spasm or ectasia
- LV ejection fraction < 52% in males or < 54% in females
- Abnormal heart structure (congenital heart disease, cardiomyopathies, or valvular dysfunction)
- Pericardial disease (pericardial effusion or constrictive pericarditis)
- Previous history of myocardial infarction
Show all 14Show fewer
- Uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 105 mmHg)
- Hyperthyroidism
- Hypothyroidism
- Malignancy
- Autoimmune disease
- Infection
- Pulmonary, hepatic, and renal disorders
- Haematological disorders (anaemia, bone marrow involved by neoplastic disease, or red blood cell transfusions)
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease. Current guidelines support its use in patients after acute coronary syndrome, coronary artery bypass grafting, coronary stent placement, valve surgery, and stable chronic systolic heart failure. Its use in these conditions is supported by a robust body of research demonstrating improved clinical outcomes. Despite this evidence, cardiac rehabilitation referral and attendance remains low and interventions to increase its use need to be developed.
Read the detailed description
The trial was conducted in Shenzhen in China. This study will recruit 100 patients with cardiovascular disease with a median and minimum follow-up of 24 and 6 months. Patients will be individually randomized to receive either a cardiac rehabilitation program (n = 50) or enhanced standard care involving educational advice (n = 50). The co-primary outcomes are: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the Quality of Life-5 Dimensions-5 Level visual analogue scale.
- Conditions
- Cardiac Rehabilitation
- Being tested
- cardiac rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac rehabilitationBehavioural
Cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | the patients treated with cardiac rehabilitation intervention. Receives: Behavioral: cardiac rehabilitation |
| Control group | No intervention | the patients treated without cardiac rehabilitation intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
first occurrence of major adverse cardiovascular events (MACE)
first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization)
Measured: 3 years
maximum oxygen uptake
maximum oxygen uptake
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Feb 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320848
- Sponsor's protocol ID
- SY-CSF-001
- Status last verified
- Apr 2022
- First submitted
- 4 Aug 2021
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.
PubMed 26730878Ruano-Ravina A, Pena-Gil C, Abu-Assi E, Raposeiras S, van 't Hof A, Meindersma E, Bossano Prescott EI, Gonzalez-Juanatey JR. Participation and adherence to cardiac rehabilitation programs. A systematic review. Int J Cardiol. 2016 Nov 15;223:436-443. doi: 10.1016/j.ijcard.2016.08.120. Epub 2016 Aug 13.
PubMed 27557484Wong WP, Feng J, Pwee KH, Lim J. A systematic review of economic evaluations of cardiac rehabilitation. BMC Health Serv Res. 2012 Aug 8;12:243. doi: 10.1186/1472-6963-12-243.
PubMed 22873828Ragupathi L, Stribling J, Yakunina Y, Fuster V, McLaughlin MA, Vedanthan R. Availability, Use, and Barriers to Cardiac Rehabilitation in LMIC. Glob Heart. 2017 Dec;12(4):323-334.e10. doi: 10.1016/j.gheart.2016.09.004. Epub 2017 Mar 13.
PubMed 28302548Edwards K, Jones N, Newton J, Foster C, Judge A, Jackson K, Arden NK, Pinedo-Villanueva R. The cost-effectiveness of exercise-based cardiac rehabilitation: a systematic review of the characteristics and methodological quality of published literature. Health Econ Rev. 2017 Oct 19;7(1):37. doi: 10.1186/s13561-017-0173-3.
PubMed 29052044
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Cardiac Rehabilitation on the Treatment of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05320848
- Acronym / sponsor ID
- SY-CSF-001
- Conditions
- Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 11 Apr 2022 (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 valuable treatment for patients with a broad spectrum of cardiac disease. Current guidelines support its use in patients after acute coronary syndrome, coronary artery bypass grafting, coronary stent placement, valve surgery, and stable chronic systolic heart failure. Its use in these conditions is supported by a robust body of research demonstrating improved clinical outcomes. Despite this evidence, cardiac rehabilitation referral and attendance remains low and interventions to increase its use need to be developed.
Detailed description
The trial was conducted in Shenzhen in China. This study will recruit 100 patients with cardiovascular disease with a median and minimum follow-up of 24 and 6 months. Patients will be individually randomized to receive either a cardiac rehabilitation program (n = 50) or enhanced standard care involving educational advice (n = 50). The co-primary outcomes are: 1) first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the Quality of Life-5 Dimensions-5 Level visual analogue scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: cardiac rehabilitationthe patients treated with cardiac rehabilitation intervention. |
| Control group | No intervention | –the patients treated without cardiac rehabilitation intervention. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cardiovascular disease
Key exclusion criteria (14 listed)
- Incalculable TFC
- Coronary artery spasm or ectasia
- LV ejection fraction < 52% in males or < 54% in females
- Abnormal heart structure (congenital heart disease, cardiomyopathies, or valvular dysfunction)
- Pericardial disease (pericardial effusion or constrictive pericarditis)
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 |
|---|---|---|
| cardiac rehabilitationCardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease. | Behavioural | Treatment group |
Primary outcome
first occurrence of major adverse cardiovascular events (MACE)
Time frame: 3 years
first occurrence of major adverse cardiovascular events (MACE) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization)
maximum oxygen uptake
Time frame: 3 years
maximum oxygen uptake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Background: PubMed 26730878Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.
- Background: PubMed 27557484Ruano-Ravina A, Pena-Gil C, Abu-Assi E, Raposeiras S, van 't Hof A, Meindersma E, Bossano Prescott EI, Gonzalez-Juanatey JR. Participation and adherence to cardiac rehabilitation programs. A systematic review. Int J Cardiol. 2016 Nov 15;223:436-443. doi: 10.1016/j.ijcard.2016.08.120. Epub 2016 Aug 13.
- Background: PubMed 22873828Wong WP, Feng J, Pwee KH, Lim J. A systematic review of economic evaluations of cardiac rehabilitation. BMC Health Serv Res. 2012 Aug 8;12:243. doi: 10.1186/1472-6963-12-243.
- Background: PubMed 28302548Ragupathi L, Stribling J, Yakunina Y, Fuster V, McLaughlin MA, Vedanthan R. Availability, Use, and Barriers to Cardiac Rehabilitation in LMIC. Glob Heart. 2017 Dec;12(4):323-334.e10. doi: 10.1016/j.gheart.2016.09.004. Epub 2017 Mar 13.
- Background: PubMed 29052044Edwards K, Jones N, Newton J, Foster C, Judge A, Jackson K, Arden NK, Pinedo-Villanueva R. The cost-effectiveness of exercise-based cardiac rehabilitation: a systematic review of the characteristics and methodological quality of published literature. Health Econ Rev. 2017 Oct 19;7(1):37. doi: 10.1186/s13561-017-0173-3.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac rehabilitation in people with Cardiac Rehabilitation, run by Shenzhen People's Hospital 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 1 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 11 Apr 2022. 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?
Results are not available in the source record.
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?
first occurrence of major adverse cardiovascular events (MACE) (time frame: 3 years). 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 NCT05320848, which also lists 5 linked publications.
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 Apr 2022.