The Therapeutic Effect of Phase I Cardiac Rehabilitation on Elderly Patients With CHD Complicated by Sarcopenia

NCT07197463 | Not Yet Recruiting

• 1 other identifier: KYLL-202504-007-1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this clinical trial is to explore whether Phase I cardiac rehabilitation can treat elderly patients with coronary heart disease complicated by sarcopenia. It will also investigate the mechanism of Phase I cardiac rehabilitation. The main questions it aims to answer are:

• Can Phase I cardiac rehabilitation enhance muscle strength ?
• Can Phase I cardiac rehabilitation reduce in vivo inflammatory indicators? Researchers will compare the experimental group (Phase I cardiac rehabilitation + drug therapy + general treatment) with the control group (drug therapy + general treatment) to see if Phase I cardiac rehabilitation can treat elderly patients with coronary heart disease complicated by sarcopenia and reduce inflammatory indicators. Participants will:
• Receive Phase I cardiac rehabilitation training（mainly includes low-intensity resistance training, breathing training and bedside cycling） or conventional drug therapy for 3 consecutive months.
• Undergo examinations 10 days after training, 1 month after discharge, and 3 months after discharge respectively.
• Record changes in their muscle strength and blood inflammatory indicators.

Conditions

Coronary Disease; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Change in Grip Strength

  The primary outcome measure is the change in muscle strength.Muscle strength is measured using a hand dynamometer. Participants are instructed to grip the dynamometer with their dominant hand at maximum effort, and the maximum grip force value is recorded (unit: kgf).

  From enrollment（ baseline）to 1 month after treatment initiation

Secondary Outcomes (1)

• Change in Grip Strength

  From enrollment（ baseline）to 3 month after treatment initiation

Study Arms (2)

Phase I Cardiac Rehabilitation Experimental Group

EXPERIMENTAL

Phase I cardiac rehabilitation（ low-intensity resistance training, breathing exercises, and bedside cycling） + drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking）

Other: drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking）

General Treatment Group

ACTIVE COMPARATOR

drug therapy（Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking）

Other: drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking）

Interventions

drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking） OTHER

The experimental group received Phase I cardiac rehabilitation intervention + medication treatment + general treatment, while the control group only received medication treatment + general treatment.

General Treatment Group; Phase I Cardiac Rehabilitation Experimental Group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years;
• Coronary heart disease confirmed by coronary CTA or coronary angiography, with stable condition within the past 8 hours, including: ① no new or recurrent chest pain; ② no further elevation of troponin level; ③ no new signs of decompensated heart failure (dyspnea at rest accompanied by moist rales); ④ no new malignant arrhythmias or dynamic changes in electrocardiogram. Basic vital signs are normal, including: ① resting heart rate of 50-100 beats per minute; ② resting blood pressure of 90-150/60-100 mmHg (1 mmHg = 0.133 kPa); ③ oxygen saturation \> 95%.
• Meeting the diagnostic criteria for sarcopenia (2024 Edition of Chinese Guidelines for the Diagnosis and Treatment of Sarcopenia);
• Having good compliance to ensure the completion of this study;
• Being able to understand the purpose of the trial, voluntarily participating in the study and signing the informed consent form.

You may not qualify if:

• Severe arrhythmia, decompensated heart failure, severe respiratory failure, untreated severe aortic stenosis, acute aortic dissection, resting hypertension with systolic and/or diastolic blood pressure \> 200/110 mmHg;
• Mental disorders with limited cooperation ability; severe cognitive or behavioral disorders; end-stage diseases; acute diseases (e.g., acute infections, injuries) that restrict physical activity;
• Poor compliance and inability to cooperate with the completion of this study.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

MeSH Terms

Conditions

Coronary Disease; Sarcopenia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Yanyan Hu, Doctor

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Yanyan Hu, Doctor

CONTACT

18560082229; yyhu78@163.com

Yuanyuan Wang, Doctor

CONTACT

18560082265; wangyuanyuan1204@email.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: September 29, 2025
• Study Start: October 10, 2025
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share