Coronary Heart DiseaseNCT06588231
Effect of Individualized Exercise in Elderly Patients With Coronary Heart Disease
A study testing Individual rehabilitation exercise training and optimal medical therapy ：aspirin, clopidogrel, statins. in people with Coronary Heart Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The benefits of cardiac rehabilitation have been supported by a large amount of evidence-based medicine. Cardiac rehabilitation can correct cardiovascular risk factors, reduce morbidity and mortality, and improve quality of life. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Individual rehabilitation exercise training and optimal medical therapy ：aspirin, clopidogrel, statins.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2023to 17 Aug 2025
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary heart disease: coronary angiography confirmed patients with coronary heart disease.
- Age is 60-75 years old, and the clinical sinus rhythm is stable.
- Left ventricular ejection fraction was> 40%.
- Informed consent and voluntary participation.
Who cannot join
- Patients with severe organic cardiac and lung diseases.
- Patients with hemiplegia and other physical action disorders.
- A history of mental illness.
- Uncontrolled hypertension, and hemodynamic instability.
- Severe nephropathy and severe peripheral artery disease.
- Patients with bone and joint diseases who are not suitable for exercise.
- Uncontrolled endocrine system and other diseases.
- Antibiotics and anti-diarrheal medications have not been used for at least 3 months.
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 First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Leilei L Chen, 18651856055, Chenlei19762002@163.com
About this study
Official title: Effect of Individualized Exercise Based on CPET on Multiple Cardiovascular Risk Factors and Cardiopulmonary Function in Elderly Patients With Coronary Heart Disease
The benefits of cardiac rehabilitation have been supported by a large amount of evidence-based medicine. Cardiac rehabilitation can correct cardiovascular risk factors, reduce morbidity and mortality, and improve quality of life.
Read the detailed description
Cardiac rehabilitation includes drug, exercise, nutrition, psychological and behavioral intervention, smoking and alcohol restriction five prescription comprehensive medical measures, so as to improve the symptoms and prognosis of patients. Cardiac rehabilitation can not only delay the progress of the disease and improve the prognosis, but also improve the physical and mental state of patients, which has been recommended by the European Cardiology Association, the American Heart Association and the American Heart Association as Class I in the treatment of cardiovascular disease. Through the comprehensive intervention of patients, their physical, psychological and social functions can be restored to the best state, which can prolong life and significantly improve the quality of life, which is the essence of modern cardiac rehabilitation. Exercise rehabilitation is the core content of cardiac rehabilitation, which refers to the use of appropriate body exercise to help patients promote physical and mental health through exercise prescription and exercise guidance on the basis of comprehensive evaluation. The realization of sports rehabilitation requires a reasonable exercise prescription, which refers to the method of prescribing patients' exercise content and amount of exercise in the form of prescription according to individual physical condition and combining with environment and preference as far as possible. The best exercise prescription should be able to comprehensively promote health-related physical fitness, that is, cardiopulmonary endurance, muscle strength and endurance, flexibility, body composition and neuromotor fitness, and should be formulated in accordance with the principles of FITTVP, including frequency (several times a week), intensity (exertion), time (duration or total time), mode (pattern or type), as well as total and progress.
- Conditions
- Coronary Heart Disease
- Being tested
- Individual rehabilitation exercise training, optimal medical therapy ：aspirin, clopidogrel, statins.
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual rehabilitation exercise trainingBehavioural
Under the guidance of a specialist, medium-and high-intensity interval training was conducted for 16 weeks, 3 times a week, 30-40 minutes each time, including the beginning of 5 minutes of warm-up and the last 5 minutes of cooling-off period, during which the exercise included 4 intervals, with the 85-95% pre intensity of HR reserve for 15-18 minutes, and then with the 50-70% pre intensity of HR reserve for 12-14 minutes, exercise for 3 minutes, and so on for 4 times. Warm-up and cooling-off periods can be done through stretching exercises, flexibility exercises (that is, neck, shoulders, upper back, buttocks and ankles) and low and medium intensity (50-70% heart rate reserve)
optimal medical therapy ：aspirin, clopidogrel, statins.Drug
Also called optimal medical therapy
those in the control group were treated with routine antiplatelet drugs and lipid-lowering drugs after operation. Professional salesmen, according to the specific physical conditions of the patients, formulate corresponding recipes to ensure that the patients have a light diet, low salt, low fat and high nutritional value, and prohibit tobacco and alcohol.
| Study group | Role | What they receive |
|---|---|---|
| the control group | Active comparator | The patients in the control group were treated with routine rehabilitation nursing, while those in the control group were treated with routine antiplatelet drugs and lipid-lowering drugs after operation. Professional salesmen, according to the specific physical conditions of the patients, formulate corresponding recipes to ensure that the patients have a light diet, low salt, low fat and high nutritional value, and prohibit tobacco and alcohol. Receives: Drug: optimal medical therapy ：aspirin, clopidogrel, statins. |
| the exercise group | Experimental | The exercise group was given individualized rehabilitation training intervention on the basis of the control group. After 2 weeks of adaptive exercise training, there were no adverse events and voluntarily continued the participants. Under the guidance of the specialist, the exercise group received moderate and high intensity interval training, 3 times a week, 30-40 minutes each time, including the beginning of 5 minutes of warm-up and the last 5 minutes of cooling-off period. Receives: Behavioral: Individual rehabilitation exercise training; Drug: optimal medical therapy ：aspirin, clopidogrel, statins. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome
Fecal DNA isolation was performed using the QIA amp Fast DNA Stool Mini Kit (Qiagen, cat. 51604). After DNA extraction, fecal DNA was used for library preparation, and whole-genome shotgun sequencing was performed on the Illumina NovaSeq-6000 plat- form. From the raw metagenomic sequencing data, low-quality reads were discarded by the sequencing facility and reads belonging to human contaminations were removed by mapping the data to the reference genomes using Bowtie2. After filtering, on average, 54.8 million paired reads per sample were obtained for subsequent analysis.
Measured: one year
Plasma metabolites profiles
Microbial metabolites profiles were generated using MetaPhlAn4 (version 4.0.3).
Measured: one year
6MWT
6-minute walk test
Measured: one year
LDL
low density lipoprotein
Measured: one year
VO2peak
peak oxygen uptake
Measured: one year
Secondary outcomes (1)
Plasma metabolites concentration
The untargeted metabolome analysis was performed using an LC-MS/MS system.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Oct 2023
- Primary completion17 Dec 2024
- Study completion17 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Leilei, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Leilei Chen, Study director, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588231
- Sponsor's protocol ID
- IECHD
- Status last verified
- Dec 2024
- First submitted
- 28 Aug 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Individualized Exercise Based on CPET on Multiple Cardiovascular Risk Factors and Cardiopulmonary Function in Elderly Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT06588231
- Acronym / sponsor ID
- IECHD
- Conditions
- Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Aug 2025 (estimated)
- First posted
- 19 Sep 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.
The benefits of cardiac rehabilitation have been supported by a large amount of evidence-based medicine. Cardiac rehabilitation can correct cardiovascular risk factors, reduce morbidity and mortality, and improve quality of life.
Detailed description
Cardiac rehabilitation includes drug, exercise, nutrition, psychological and behavioral intervention, smoking and alcohol restriction five prescription comprehensive medical measures, so as to improve the symptoms and prognosis of patients. Cardiac rehabilitation can not only delay the progress of the disease and improve the prognosis, but also improve the physical and mental state of patients, which has been recommended by the European Cardiology Association, the American Heart Association and the American Heart Association as Class I in the treatment of cardiovascular disease. Through the comprehensive intervention of patients, their physical, psychological and social functions can be restored to the best state, which can prolong life and significantly improve the quality of life, which is the essence of modern cardiac rehabilitation. Exercise rehabilitation is the core content of cardiac rehabilitation, which refers to the use of appropriate body exercise to help patients promote physical and mental health through exercise prescription and exercise guidance on the basis of comprehensive evaluation. The realization of sports rehabilitation requires a reasonable exercise prescription, which refers to the method of prescribing patients' exercise content and amount of exercise in the form of prescription according to individual physical condition and combining with environment and preference as far as possible. The best exercise prescription should be able to comprehensively promote health-related physical fitness, that is, cardiopulmonary endurance, muscle strength and endurance, flexibility, body composition and neuromotor fitness, and should be formulated in accordance with the principles of FITTVP, including frequency (several times a week), intensity (exertion), time (duration or total time), mode (pattern or type), as well as total and progress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the control group | Active comparator | Drug: optimal medical therapy ：aspirin, clopidogrel, statins.The patients in the control group were treated with routine rehabilitation nursing, while those in the control group were treated with routine antiplatelet drugs and lipid-lowering drugs after operation. Professional salesmen, according to the specific physical conditions of the patients, formulate corresponding recipes to ensure that the patients have a light diet, low salt, low fat and high nutritional value, and prohibit tobacco and alcohol. |
| the exercise group | Experimental | Behavioral: Individual rehabilitation exercise training, Drug: optimal medical therapy ：aspirin, clopidogrel, statins.The exercise group was given individualized rehabilitation training intervention on the basis of the control group. After 2 weeks of adaptive exercise training, there were no adverse events and voluntarily continued the participants. Under the guidance of the specialist, the exercise group received moderate and high intensity interval training, 3 times a week, 30-40 minutes each time, including the beginning of 5 minutes of warm-up and the last 5 minutes of cooling-off period. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Coronary heart disease: coronary angiography confirmed patients with coronary heart disease.
- Age is 60-75 years old, and the clinical sinus rhythm is stable.
- Left ventricular ejection fraction was> 40%.
- Informed consent and voluntary participation.
Key exclusion criteria (8 listed)
- Patients with severe organic cardiac and lung diseases.
- Patients with hemiplegia and other physical action disorders.
- A history of mental illness.
- Uncontrolled hypertension, and hemodynamic instability.
- Severe nephropathy and severe peripheral artery disease.
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 |
|---|---|---|
| Individual rehabilitation exercise trainingUnder the guidance of a specialist, medium-and high-intensity interval training was conducted for 16 weeks, 3 times a week, 30-40 minutes each time, including the beginning of 5 minutes of warm-up and the last 5 minutes of cooling-off period, during which the exercise included 4 intervals, with the 85-95% pre intensity of HR reserve for 15-18 minutes, and then with the 50-70% pre intensity of HR reserve for 12-14 minutes, exercise for 3 minutes, and so on for 4 times. Warm-up and cooling-off periods can be done through stretching exercises, flexibility exercises (that is, neck, shoulders, upper back, buttocks and ankles) and low and medium intensity (50-70% heart rate reserve) | Behavioural | the exercise group |
| optimal medical therapy ：aspirin, clopidogrel, statins.Also: optimal medical therapythose in the control group were treated with routine antiplatelet drugs and lipid-lowering drugs after operation. Professional salesmen, according to the specific physical conditions of the patients, formulate corresponding recipes to ensure that the patients have a light diet, low salt, low fat and high nutritional value, and prohibit tobacco and alcohol. | Drug | the control group, the exercise group |
Primary outcome
Gut microbiome
Time frame: one year
Fecal DNA isolation was performed using the QIA amp Fast DNA Stool Mini Kit (Qiagen, cat. 51604). After DNA extraction, fecal DNA was used for library preparation, and whole-genome shotgun sequencing was performed on the Illumina NovaSeq-6000 plat- form. From the raw metagenomic sequencing data, low-quality reads were discarded by the sequencing facility and reads belonging to human contaminations were removed by mapping the data to the reference genomes using Bowtie2. After filtering, on average, 54.8 million paired reads per sample were obtained for subsequent analysis.
Plasma metabolites profiles
Time frame: one year
Microbial metabolites profiles were generated using MetaPhlAn4 (version 4.0.3).
6MWT
Time frame: one year
6-minute walk test
LDL
Time frame: one year
low density lipoprotein
VO2peak
Time frame: one year
peak oxygen uptake
1 secondary outcome
Plasma metabolites concentration
Time frame: one year
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 31 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Coronary Heart Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Leilei Chen study director
the First Affiliated Hospital of Nanjing Medical University, Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual rehabilitation exercise training and optimal medical therapy ：aspirin, clopidogrel, statins. in people with Coronary Heart Disease, run by The First Affiliated Hospital with Nanjing Medical 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 4 inclusion and 8 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 31 Dec 2024. 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 Leilei Chen (18651856055, Chenlei19762002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome (time frame: one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2024.