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NCT Number: NCT06588231

Effect of Individualized Exercise in Elderly Patients With Coronary Heart Disease

The benefits of cardiac rehabilitation have been supported by a large amount of evidence-based medicine. Cardiac rehabilitation can correct cardiovascular risk factors, reduce morbidity and mortality, and improve quality of life.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Leilei L Chen

CONTACT

[email protected]

18651856055

About this study

Cardiac rehabilitation includes drug, exercise, nutrition, psychological and behavioral intervention, smoking and alcohol restriction five prescription comprehensive medical measures, so as to improve the symptoms and prognosis of patients. Cardiac rehabilitation can not only delay the progress of the disease and improve the prognosis, but also improve the physical and mental state of patients, which has been recommended by the European Cardiology Association, the American Heart Association and the American Heart Association as Class I in the treatment of cardiovascular disease. Through the comprehensive intervention of patients, their physical, psychological and social functions can be restored to the best state, which can prolong life and significantly improve the quality of life, which is the essence of modern cardiac rehabilitation. Exercise rehabilitation is the core content of cardiac rehabilitation, which refers to the use of appropriate body exercise to help patients promote physical and mental health through exercise prescription and exercise guidance on the basis of comprehensive evaluation. The realization of sports rehabilitation requires a reasonable exercise prescription, which refers to the method of prescribing patients' exercise content and amount of exercise in the form of prescription according to individual physical condition and combining with environment and preference as far as possible. The best exercise prescription should be able to comprehensively promote health-related physical fitness, that is, cardiopulmonary endurance, muscle strength and endurance, flexibility, body composition and neuromotor fitness, and should be formulated in accordance with the principles of FITTVP, including frequency (several times a week), intensity (exertion), time (duration or total time), mode (pattern or type), as well as total and progress.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Coronary heart disease: coronary angiography confirmed patients with coronary heart disease.
  • Age is 60-75 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.
  • 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.

Treatment and study plan

Individual rehabilitation exercise training

Behavioral

Under the guidance of a specialist, medium-and high-intensity interval training was conducted for 16 weeks, 3 times a week, 30-40 minutes each time, including the beginning of 5 minutes of warm-up and the last 5 minutes of cooling-off period, during which the exercise included 4 intervals, with the 85-95% pre intensity of HR reserve for 15-18 minutes, and then with the 50-70% pre intensity of HR reserve for 12-14 minutes, exercise for 3 minutes, and so on for 4 times. Warm-up and cooling-off periods can be done through stretching exercises, flexibility exercises (that is, neck, shoulders, upper back, buttocks and ankles) and low and medium intensity (50-70% heart rate reserve)

optimal medical therapy :aspirin, clopidogrel, statins.

Drug

those in the control group were treated with routine antiplatelet drugs and lipid-lowering drugs after operation. Professional salesmen, according to the specific physical conditions of the patients, formulate corresponding recipes to ensure that the patients have a light diet, low salt, low fat and high nutritional value, and prohibit tobacco and alcohol.

Other names: optimal medical therapy

Primary outcomes

  1. Gut microbiome

    Time frame: one year

    Fecal DNA isolation was performed using the QIA amp Fast DNA Stool Mini Kit (Qiagen, cat. 51604). 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. After filtering, on average, 54.8 million paired reads per sample were obtained for subsequent analysis.

  2. Plasma metabolites profiles

    Time frame: one year

    Microbial metabolites profiles were generated using MetaPhlAn4 (version 4.0.3).

  3. 6MWT

    Time frame: one year

    6-minute walk test

  4. LDL

    Time frame: one year

    low density lipoprotein

  5. VO2peak

    Time frame: one year

    peak oxygen uptake

Secondary outcomes

  1. Plasma metabolites concentration

    Time frame: one year

    The untargeted metabolome analysis was performed using an LC-MS/MS system.

Study contacts

Contact information is provided by the study sponsor or research team.

Leilei Chen

CONTACT

[email protected]

18651856055

Mei Wang

CONTACT

[email protected]

+8615256095215

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

Effect of Individualized Exercise Based on CPET on Multiple Cardiovascular Risk Factors and Cardiopulmonary Function in Elderly Patients With Coronary Heart Disease

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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