Coronary DiseaseNCT07197463
The Therapeutic Effect of Phase I Cardiac Rehabilitation on Elderly Patients With CHD Complicated by Sarcopenia
A study testing drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking） in people with Coronary Disease and Sarcopenia, run by Qilu Hospital of Shandong University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Coronary Disease, Sarcopenia
- What is being tested?
- drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2025to 10 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Therapeutic Effect of Phase I Cardiac Rehabilitation on Elderly Patients With Coronary Heart Disease Complicated by Sarcopenia:A Single Center, Randomized Control Study in China
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Coronary Disease, Sarcopenia
- Being tested
- drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking）
- Medical subject headings
- Coronary Disease, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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） Receives: Other: drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking） |
| General Treatment Group | Active comparator | drug therapy（Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking） Receives: Other: drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: From enrollment（ baseline）to 3 month after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start10 Oct 2025 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanyan Hu, Doctor, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197463
- Sponsor's protocol ID
- KYLL-202504-007-1
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Therapeutic Effect of Phase I Cardiac Rehabilitation on Elderly Patients With Coronary Heart Disease Complicated by Sarcopenia:A Single Center, Randomized Control Study in China
- ClinicalTrials.gov ID
- NCT07197463
- Acronym / sponsor ID
- KYLL-202504-007-1
- Conditions
- Coronary Disease, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I Cardiac Rehabilitation Experimental Group | Experimental | Other: drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking）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 | Other: drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking）drug therapy（Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking） |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking）The experimental group received Phase I cardiac rehabilitation intervention + medication treatment + general treatment, while the control group only received medication treatment + general treatment. | Other | General Treatment Group, Phase I Cardiac Rehabilitation Experimental Group |
Primary outcome
Change in Grip Strength
Time frame: From enrollment（ baseline）to 1 month after treatment initiation
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).
1 secondary outcome
Change in Grip Strength
Time frame: From enrollment（ baseline）to 3 month after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanyan Hu, Doctor study chair
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
A study testing drug therapy （Aspirin, Atorvastatin, Nitroglycerin）+ general treatment（quit smoking） in people with Coronary Disease and Sarcopenia, run by Qilu Hospital of Shandong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanyan Hu, Doctor (18560082229, yyhu78@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Grip Strength (time frame: From enrollment（ baseline）to 1 month after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.