Effect of Individualized Exercise in Elderly Patients With Coronary Heart Disease

NCT06588231 | Recruiting

• 1 other identifier: IECHD
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (5)

• Gut microbiome

  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.

  one year

• Plasma metabolites profiles

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

  one year

• 6MWT

  6-minute walk test

  one year

• LDL

  low density lipoprotein

  one year

• VO2peak

  peak oxygen uptake

  one year

Secondary Outcomes (1)

• Plasma metabolites concentration

  one year

Study Arms (2)

the control group

ACTIVE COMPARATOR

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.

Drug: optimal medical therapy ：aspirin, clopidogrel, statins.

the exercise group

EXPERIMENTAL

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.

Behavioral: Individual rehabilitation exercise training; Drug: optimal medical therapy ：aspirin, clopidogrel, statins.

Interventions

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)

the exercise group

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.

Also known as: optimal medical therapy

the control group; the exercise group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.
• 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)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Interventions

Clopidogrel; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Leilei Chen

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

  STUDY DIRECTOR

Central Study Contacts

Leilei Chen

CONTACT

18651856055; Chenlei19762002@163.com

Mei Wang

CONTACT

+8615256095215; 1513267113@qq.com

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 28, 2024
• First Posted: September 19, 2024
• Study Start: October 17, 2023
• Primary Completion: December 17, 2024
• Study Completion: August 17, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)