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

NCT06575569 | Completed

• 1 other identifier: HIIT-PCI
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (4)

• 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.

  12 weeks

• Plasma metabolite Traumatic acid

  Plasma

  12 weeks

• 6MWT

  6-minute walk test

  12 weeks

• VO2peak

  CPET

  12 weeks

Study Arms (2)

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.

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).

Behavioral: Moderate-intensity continuous training

Interventions

high-intensity interval training 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.

Also known as: HIIT

high-intensity interval training (HIIT) group

Moderate-intensity continuous training 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.

Also known as: MCT

Moderate-intensity continuous training (MCT) group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, China

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Leilei Chen

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 28, 2024
• Study Start: June 17, 2023
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)