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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Phase I Cardiac Rehabilitation Experimental GroupExperimental treatment 1 intervention
Group B: General Treatment GroupActive comparator 1 intervention

Trial outcomes

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).

Time frame
From enrollment( baseline)to 1 month after treatment initiation

Secondary 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).

Time frame
From enrollment( baseline)to 3 month after treatment initiation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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