Coronary Heart DiseaseNCT06575569
Effect of HIIT on Cardiopulmonary Function After PCI in Patients With Coronary Heart Disease
A study testing high-intensity interval training and Moderate-intensity continuous training in people with Coronary Heart Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Both the gut microbiome and exercise are closely related to human health, but the understanding of the effect of high-intensity interval training (HIIT) on cardiopulmonary function and human intestinal flora is still further study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- high-intensity interval training and Moderate-intensity continuous training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2023to 17 Dec 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary angiography confirmed patients with coronary heart disease, which was at least one coronary vessel with a stenosis greater than 70%.
- Age is 18-70 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.(4) 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.
China1 site
Department of Cardiology ,the First Affiliated Hospital of Nanjing Medical University
Nanjing
About this study
Official title: Effect of High-intensity Intermittent Rehabilitation Training on Cardiopulmonary Function After PCI in Patients With Coronary Heart Disease
Both the gut microbiome and exercise are closely related to human health, but the understanding of the effect of high-intensity interval training (HIIT) on cardiopulmonary function and human intestinal flora is still further study.
Read the detailed description
As one of the most causes mortality all over the world, coronary heart disease (CHD) contributes to about 1.78 billion in Europe, 0.36 all deaths in the United States and over 110 million individuals worldwide each year, which has been a heavy burden on health expenditure. The treatment ways of CHD mainly include life way, drugs, and percutaneous coronary intervention (PCI). Even though, in past decades PCI technique has developed rapidly and today is a main treatment for patients with CHD. It was reported than healthcare costs will reach $177 billion by 2024 in the United States. In Europe, productivity losses were £13,953 per person per year because of CHD. Despite the traditional treatment, costs and mortality owing to CHD are still high, which highlights the need for research of the relationships between CHD and systems other than the cardiovascular system and comorbidities. The investigators need to search for new measures to improve traditional treatment ways of CHD. With the development of high-throughput sequencing technology, numbers of studies have showed that closely relationship between gut microbiota and cardiopulmonary function, blood glucose, lipid and cholesterol profiles and some inflammatory markers in patients with chronic disease. Regulation of intestinal flora may have preventive effect on disease. However, the study for relationship of CHD and gut microbiota is few reports. Health is a topic of common concern around the world. Increasing attention to the status of CHD and finding exercise prescriptions that effectively regulate the intestinal flora may lay the foundation for the prevention and treatment of chronic diseases such as CHD.
Some experiments have demonstrated that High-intensity interval training (HIIT) can change the diversity and metabolic capacity of gut microbiota. Therefore, it is necessary to conduct more studies to figure out whether exercise training could improve gut microbiota and bring benefit to human.
This study will explore whether 12 weeks of HIIT can effectively change the structure of human with CHD intestinal flora, so as to provide a theoretical basis for the human with CHD and exercise intervention in the treatment of intestinal flora related diseases.
- Conditions
- Coronary Heart Disease
- Being tested
- high-intensity interval training, Moderate-intensity continuous training
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity interval trainingBehavioural
Also called HIIT
Patients had no adverse events after 2 weeks of adaptive exercise training and voluntarily continued participants, intensive interval training under the care of specialists for 12 weeks, 30-40 minutes per week, including starting 5-minute warm-up and last 5-minute cooling-off period, during exercise including 4 intervals, 85-95% of maximum heart rate (HR) reserve for 4 minutes, followed by 50-70% of maximum HR reserve for 3 minutes, so cycling 4 times. Specific exercise logs will be issued for patients to record exercise conditions and related exercise data, encouraged to exercise regularly and health education materials pushed by cardiovascular nurses.
Moderate-intensity continuous trainingBehavioural
Also called MCT
Using routine postoperative care and follow-up, establish WeChat group as contact for postoperative follow-up, no adverse events after 2 weeks of adaptive exercise training and voluntary participants, patients exercise prescription for 12 weeks, 30-40 minutes, including 5 minutes of warm-up and cooling-off period of the last 5 minutes, during exercise intensity is 70-75% maximum heart rate reserve. The warm-up and cooling-off periods can be performed by stretching, flexibility exercises (i. e., neck, shoulders, upper back, hips, and ankles), and medium to low intensity (50-70% heart rate reserve). Specific exercise logs will be issued for patients to record exercise conditions and related exercise data, encouraged to exercise regularly and pushed health education materials by cardiovascular nurses.
| Study group | Role | What they receive |
|---|---|---|
| high-intensity interval training (HIIT) group | Experimental | intensive interval training under the care of specialists for 12 weeks, 30-40 minutes per week, including starting 5-minute warm-up and last 5-minute cooling-off period, during exercise including 4 intervals, 85-95% of maximum heart rate (HR) reserve for 4 minutes, followed by 50-70% of maximum HR reserve for 3 minutes, so cycling 4 times. Receives: Behavioral: high-intensity interval training |
| Moderate-intensity continuous training (MCT) group | Active comparator | patients exercise prescription for 12 weeks, 30-40 minutes, including 5 minutes of warm-up and cooling-off period of the last 5 minutes, during exercise intensity is 70-75% maximum heart rate reserve. The warm-up and cooling-off periods can be performed by stretching, flexibility exercises (i. e., neck, shoulders, upper back, hips, and ankles), and medium to low intensity (50-70% heart rate reserve). Receives: Behavioral: Moderate-intensity continuous training |
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. 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 (RRID:SCR _ 016368 ; v2.4.5). After filtering, on average, 54.8 million (SD = 14.7 million) paired reads per sample were obtained for subsequent analysis.
Measured: 12 weeks
Plasma metabolite Traumatic acid
Plasma
Measured: 12 weeks
6MWT
6-minute walk test
Measured: 12 weeks
VO2peak
CPET
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start17 Jun 2023
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
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
- 67 participants (actual)
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 with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575569
- Sponsor's protocol ID
- HIIT-PCI
- Status last verified
- Jan 2025
- First submitted
- 20 Aug 2024
- Last updated
- 7 Jan 2025
- 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-intensity Intermittent Rehabilitation Training on Cardiopulmonary Function After PCI in Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT06575569
- Acronym / sponsor ID
- HIIT-PCI
- Conditions
- Coronary Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 17 Jun 2023 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 28 Aug 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.
Both the gut microbiome and exercise are closely related to human health, but the understanding of the effect of high-intensity interval training (HIIT) on cardiopulmonary function and human intestinal flora is still further study.
Detailed description
As one of the most causes mortality all over the world, coronary heart disease (CHD) contributes to about 1.78 billion in Europe, 0.36 all deaths in the United States and over 110 million individuals worldwide each year, which has been a heavy burden on health expenditure. The treatment ways of CHD mainly include life way, drugs, and percutaneous coronary intervention (PCI). Even though, in past decades PCI technique has developed rapidly and today is a main treatment for patients with CHD. It was reported than healthcare costs will reach $177 billion by 2024 in the United States. In Europe, productivity losses were £13,953 per person per year because of CHD. Despite the traditional treatment, costs and mortality owing to CHD are still high, which highlights the need for research of the relationships between CHD and systems other than the cardiovascular system and comorbidities. The investigators need to search for new measures to improve traditional treatment ways of CHD. With the development of high-throughput sequencing technology, numbers of studies have showed that closely relationship between gut microbiota and cardiopulmonary function, blood glucose, lipid and cholesterol profiles and some inflammatory markers in patients with chronic disease. Regulation of intestinal flora may have preventive effect on disease. However, the study for relationship of CHD and gut microbiota is few reports. Health is a topic of common concern around the world. Increasing attention to the status of CHD and finding exercise prescriptions that effectively regulate the intestinal flora may lay the foundation for the prevention and treatment of chronic diseases such as CHD.
Some experiments have demonstrated that High-intensity interval training (HIIT) can change the diversity and metabolic capacity of gut microbiota. Therefore, it is necessary to conduct more studies to figure out whether exercise training could improve gut microbiota and bring benefit to human.
This study will explore whether 12 weeks of HIIT can effectively change the structure of human with CHD intestinal flora, so as to provide a theoretical basis for the human with CHD and exercise intervention in the treatment of intestinal flora related diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-intensity interval training (HIIT) group | Experimental | Behavioral: high-intensity interval trainingintensive interval training under the care of specialists for 12 weeks, 30-40 minutes per week, including starting 5-minute warm-up and last 5-minute cooling-off period, during exercise including 4 intervals, 85-95% of maximum heart rate (HR) reserve for 4 minutes, followed by 50-70% of maximum HR reserve for 3 minutes, so cycling 4 times. |
| Moderate-intensity continuous training (MCT) group | Active comparator | Behavioral: Moderate-intensity continuous trainingpatients exercise prescription for 12 weeks, 30-40 minutes, including 5 minutes of warm-up and cooling-off period of the last 5 minutes, during exercise intensity is 70-75% maximum heart rate reserve. The warm-up and cooling-off periods can be performed by stretching, flexibility exercises (i. e., neck, shoulders, upper back, hips, and ankles), and medium to low intensity (50-70% heart rate reserve). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- coronary angiography confirmed patients with coronary heart disease, which was at least one coronary vessel with a stenosis greater than 70%.
- Age is 18-70 years old, and the clinical sinus rhythm is stable.
- Left ventricular ejection fraction was> 40%.
- Informed consent and voluntary participation.
Key exclusion criteria (7 listed)
- Patients with severe organic cardiac and lung diseases.
- Patients with hemiplegia and other physical action disorders.
- A history of mental illness.(4) Uncontrolled hypertension, and hemodynamic instability.
- Severe nephropathy and severe peripheral artery disease.
- Patients with bone and joint diseases who are not suitable for exercise.
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 |
|---|---|---|
| high-intensity interval trainingAlso: HIITPatients had no adverse events after 2 weeks of adaptive exercise training and voluntarily continued participants, intensive interval training under the care of specialists for 12 weeks, 30-40 minutes per week, including starting 5-minute warm-up and last 5-minute cooling-off period, during exercise including 4 intervals, 85-95% of maximum heart rate (HR) reserve for 4 minutes, followed by 50-70% of maximum HR reserve for 3 minutes, so cycling 4 times. Specific exercise logs will be issued for patients to record exercise conditions and related exercise data, encouraged to exercise regularly and health education materials pushed by cardiovascular nurses. | Behavioural | high-intensity interval training (HIIT) group |
| Moderate-intensity continuous trainingAlso: MCTUsing routine postoperative care and follow-up, establish WeChat group as contact for postoperative follow-up, no adverse events after 2 weeks of adaptive exercise training and voluntary participants, patients exercise prescription for 12 weeks, 30-40 minutes, including 5 minutes of warm-up and cooling-off period of the last 5 minutes, during exercise intensity is 70-75% maximum heart rate reserve. The warm-up and cooling-off periods can be performed by stretching, flexibility exercises (i. e., neck, shoulders, upper back, hips, and ankles), and medium to low intensity (50-70% heart rate reserve). Specific exercise logs will be issued for patients to record exercise conditions and related exercise data, encouraged to exercise regularly and pushed health education materials by cardiovascular nurses. | Behavioural | Moderate-intensity continuous training (MCT) group |
Primary outcome
Gut microbiome
Time frame: 12 weeks
Fecal DNA isolation was performed using the QIA amp Fast DNA Stool Mini Kit. 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 (RRID:SCR _ 016368 ; v2.4.5). After filtering, on average, 54.8 million (SD = 14.7 million) paired reads per sample were obtained for subsequent analysis.
Plasma metabolite Traumatic acid
Time frame: 12 weeks
Plasma
6MWT
Time frame: 12 weeks
6-minute walk test
VO2peak
Time frame: 12 weeks
CPET
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 7 Jan 2025.
- 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.
Leilei Chen study director
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-intensity interval training and Moderate-intensity continuous training 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 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: finished, as of the sponsor's last update on 7 Jan 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?
Gut microbiome (time frame: 12 weeks). The study lists 4 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 7 Jan 2025.