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CompletedNCT06575569Updated Jan 7, 2025

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

An interventional study of high-intensity interval training and Moderate-intensity continuous training in Coronary Heart Disease, sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jun 2023, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 67 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: high-intensity interval training

  • Active comparator
    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).

    Behavioral: Moderate-intensity continuous training

Interventions

  • Behavioralhigh-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.

    Also known as: HIIT

  • BehavioralModerate-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.

    Also known as: MCT

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. Plasma metabolite Traumatic acid

    Plasma

    Time frame: 12 weeks

  3. 6MWT

    6-minute walk test

    Time frame: 12 weeks

  4. VO2peak

    CPET

    Time frame: 12 weeks

07

Study locations

1 site
  • Department of Cardiology ,the First Affiliated Hospital of Nanjing Medical University
    Nanjing, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06575569
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Chen Leilei (Director, The First Affiliated Hospital with Nanjing Medical University) — Principal investigator
First posted
Aug 28, 2024
Start date
Jun 17, 2023
Primary completion
Dec 17, 2024
Completion
Dec 17, 2024
Last update
Jan 7, 2025

Study contacts

Leilei Chen
study director · The First Affiliated Hospital with Nanjing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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