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Effect of Individualized Exercise in Elderly Patients With Coronary Heart Disease

NCT ID: NCT06588231

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-17

Study Completion Date

2025-08-17

Brief Summary

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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

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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.

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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the control group

The patients in the control group were treated with routine rehabilitation nursing, while 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.

Group Type ACTIVE_COMPARATOR

optimal medical therapy ：aspirin, clopidogrel, statins.

Intervention Type 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.

the exercise group

The exercise group was given individualized rehabilitation training intervention on the basis of the control group. After 2 weeks of adaptive exercise training, there were no adverse events and voluntarily continued the participants. Under the guidance of the specialist, the exercise group received moderate and high intensity interval training, 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.

Group Type EXPERIMENTAL

Individual rehabilitation exercise training

Intervention Type 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.

Intervention Type 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.

Interventions

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Individual rehabilitation exercise training

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)

Intervention Type BEHAVIORAL

optimal medical therapy ：aspirin, clopidogrel, statins.

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.

Intervention Type DRUG

Other Intervention Names

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optimal medical therapy

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chen Leilei

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leilei Chen

Role: STUDY_DIRECTOR

the First Affiliated Hospital of Nanjing Medical University, Nanjing, China

Locations

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the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Leilei Chen

Role: CONTACT

Phone: 18651856055

Email: [email protected]

Mei Wang

Role: CONTACT

Phone: +8615256095215

Email: [email protected]

Facility Contacts

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Leilei L Chen

Role: primary

Other Identifiers

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IECHD

Identifier Type: -

Identifier Source: org_study_id