Effect of HIIT on Cardiopulmonary Function After PCI in Patients With Coronary Heart Disease

NCT ID: NCT06575569

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-17
• Study Completion Date: 2024-12-17

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.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

high-intensity interval training (HIIT) group

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.

Group Type: EXPERIMENTAL

high-intensity interval training

Intervention Type: BEHAVIORAL

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 training (MCT) group

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).

Group Type: ACTIVE_COMPARATOR

Moderate-intensity continuous training

Intervention Type: BEHAVIORAL

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.

Interventions

high-intensity interval training

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.

Intervention Type: BEHAVIORAL

Moderate-intensity continuous training

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

HIIT; MCT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chen Leilei

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leilei Chen

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Department of Cardiology ,the First Affiliated Hospital of Nanjing Medical University

Nanjing, , China

Countries

China

Other Identifiers

HIIT-PCI

Identifier Type: -

Identifier Source: org_study_id