Clinical trial NCT06575569: Effect of HIIT on Cardiopulmonary Function After PCI in Patients With Coronary Heart Disease
Official title: Effect of High-intensity Intermittent Rehabilitation Training on Cardiopulmonary Function After PCI in Patients With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Gut microbiome
timeFrame: 12 weeks
measure: Plasma metabolite Traumatic acid
timeFrame: 12 weeks
measure: 6MWT
timeFrame: 12 weeks
measure: VO2peak
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Cardiology ,the First Affiliated Hospital of Nanjing Medical University
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Leilei Chen
role: STUDY_DIRECTOR
References: