Clinical trial NCT06588231: Effect of Individualized Exercise in Elderly Patients With Coronary Heart Disease
Official title: Effect of Individualized Exercise Based on CPET on Multiple Cardiovascular Risk Factors and Cardiopulmonary Function in Elderly Patients With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Heart Disease
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gut microbiome
timeFrame: one year
measure: Plasma metabolites profiles
timeFrame: one year
measure: 6MWT
timeFrame: one year
measure: LDL
timeFrame: one year
measure: VO2peak
timeFrame: one year
Secondary outcomes:
measure: Plasma metabolites concentration
timeFrame: one year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: the First Affiliated Hospital of Nanjing Medical University, Nanjing, China
name: Leilei Chen
role: STUDY_DIRECTOR
References: