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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:
Participants will:
The main purpose of this study is to explore the clinical efficacy of Phase I cardiac rehabilitation in the treatment of elderly patients with coronary heart disease complicated by sarcopenia and its potential clinical mechanisms.
The determination of this sample size is based on research hypotheses and estimates of the expected efficacy level, calculated in accordance with statistical principles. The PASS software was used for sample size estimation, with a significance level (alpha) of 0.050. Using the two independent samples t-test, 15 cases in the experimental group and 15 cases in the control group were needed to achieve a test power of >90%. To enhance the statistical power of the results, it was decided to include 50 cases in the experimental group and 50 cases in the control group, totaling 100 patients.
Research participants with high compliance were screened. Before the start of the clinical trial, researchers provided sufficient education to the participants, including the trial process, potential benefits and risks, as well as the rights and obligations of the participants. Only after the participants fully understood the trial and signed the informed consent form could they be enrolled.
SPSS generated a random number table. According to the table, odd numbers were assigned to the intervention group and even numbers to the control group, and simple randomization was used for group allocation. Statistical result analysis will be conducted at the 0.05 significance level, using SPSS statistical software.
Risk monitoring will be carried out during the trial: closely observe abnormal situations during the trial to prevent risks; promptly identify various types of risks; and on the basis of risk identification, conduct risk assessment. If risks occur, corresponding risk handling strategies will be formulated according to different risk levels. In the event of a serious adverse event, researchers will report it to the regulatory authorities and the ethics committee within 24 hours and fill out a serious adverse event report form.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| General Treatment Group | Active Comparator | drug therapy(Aspirin, Atorvastatin, Nitroglycerin)+ general treatment(quit smoking) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 3 month after treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanyan Hu, Doctor | Contact | 18560082229 | yyhu78@163.com | |
| Yuanyuan Wang, Doctor | Contact | 18560082265 | wangyuanyuan1204@email.sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanyan Hu, Doctor | Qilu Hospital of Shandong University | Study Chair |
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|
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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