The Effect of TaiChi on Ischemic Burden of Patients With Coronary Heart Disease Complicated With Renal Insufficiency

January 4, 2022 updated by: Ji Huang, Beijing Anzhen Hospital
This study focuses on patients with incomplete revascularization combined with renal insufficiency. And since heart and kidney are two organs influence each other, the study take the mechanism of heart and kidney comorbidity and the risk factors of the two organs.As one of the traditional Chinese sports, Tai Chi is an aerobic exercise combineing movements with static postures, which can significantly improve the aerobic endurance of patients with coronary heart disease. In this study, a parallel, randomized controlled study method is used to quantitatively evaluate the myocardial ischemia condition by myocardial perfusion imaging indicators. This study aims to figure out whether the cardiac rehabilitation training program based on Tai Chi has a positive effect on the patients' myocardial ischemic.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Beijing Anzhen Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 30-75 years old, all genders;
  2. At least two main vessels or their main branch vessels have obvious stenosis (≥50%) according to the coronary angiography;
  3. Received stent implantation and incomplete revascularization (incomplete revascularization: at least one vessel whose a diameter> 2.0 mm and at least one lesion with a stenosis> 50%, after PCI);
  4. eGFR<60ml/min·1.73m2;
  5. Willing to be treated and followed-up during the specified time of the study;
  6. Signed the informed consent approved by the Ethics Committee

Exclusion Criteria:

  1. Patients with high-risks according to the exercise rehabilitation risks of patients with heart disease by AACVPR;
  2. Severe cardiac insufficiency or cardiogenic shock;
  3. Combined with severe ventricular arrhythmia, ICD is required;
  4. Combined with severe pulmonary hypertension, chronic obstructive pulmonary disease, severe infectious disease, blood system disease, malignant tumor, severe liver damage, etc.;
  5. Nervous, mental and motor system diseases;
  6. Unwilling to be followed-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The experimental group
Routine treatment, and tai Chi exercise,5 times a week
Behavioral: Tai Chi Intervention Group
Tai Chi intervention group: routine treatment and tai Chi exercise,5 times a week.
No Intervention: The control group
Routine treatment, and cardiac rehabilitation is not mandatory

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Nuclein myocardial perfusion Imaging-total scores of stress perfusion（SSS）
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
The total load perfusion score indicates the extent and severity of abnormal exercise perfusion. Higher scores indicate more severe myocardial ischemia.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Nuclein myocardial perfusion Imaging-total scores of rest perfusion（SRS）
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
The total resting perfusion score (SRS) refers to the degree of myocardial ischemia at rest, with higher scores indicating more severe myocardial ischemia.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Nuclein myocardial perfusion Imaging-Total myocardial ischemia score
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
The total myocardial ischemia score reflects the extent and severity of exercise-induced ischemia, with higher scores indicating more severe myocardial ischemia.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Left ventricular ejection fraction difference（△LVEF）
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
ΔLVEF refers to the difference between the subject's post-test ejection fraction and the pre-test ejection fraction, with a larger difference indicating better improvement in cardiac function.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiopulmonary exercise test-Peak oxygen uptake (PVO2)
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Peak oxygen uptake is an important indicator of cardiopulmonary exercise function, it is the golden indicator to assess aerobic exercise capacity, the greater the peak oxygen uptake, the better the cardiopulmonary function. The unit is mL/(min-kg).
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Cardiopulmonary exercise test-Oxygen uptake to power ratio（ΔVO2/ΔＷＲ）
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
The lower the oxygen uptake to power ratio, the worse the cardiorespiratory function.The unit is mL/(min·W) .
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Cardiopulmonary exercise test-Metabolic equivalents (MET)
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Metabolic equivalent is an important indicator in cardiac rehabilitation, which is used to quantify various activities and to determine the intensity of exercise. The higher the metabolic equivalent, the better the cardiopulmonary function.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Cardiopulmonary exercise test-Carbon dioxide ventilation equivalent（VE/VCO2）
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
The higher the ratio of VE/VCO2, the lower the ventilation efficiency
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Total serum cholesterol(TC)
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Total serum cholesterol level is one of the risk factors for coronary heart disease, and the higher the total serum cholesterol level, the worse it is for cardiovascular.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
High-density lipoprotein cholesterol (HDL-C)
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
The higher the HDL cholesterol in the blood, the better it is for the cardiovascular system.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Low-density lipoprotein cholesterol (LDL-C)
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Low-density lipoprotein cholesterol is one of the risk factors for coronary heart disease, and the higher the Low-density lipoprotein cholesterol level, the worse it is for cardiovascular.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Triglycerides (TG)
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Triglycerides is one of the risk factors for coronary heart disease, and the higher the triglycerides level, the worse it is for cardiovascular.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Body Mass Index(BMI)
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
The normal value of BMI is between 20kg/m^2 and 25kg/m^2, more than 25kg/m^2 is overweight and more than 30kg/m^2 is obese.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Assess the quality of life
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
In this study, the Seattle Angina Questionnaire (SAQ) was used to measure the quality of life. The higher the patient's score on this questionnaire, the better the quality of life.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Self-rating anxiety scale(SAS)
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
The higher the score on the self-rating scale of anxiety, the more likely it is that anxiety is present.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
Self-Rating Depression scale(SDS)
Time Frame: The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.
The higher the score on the self-rating scale of anxiety, the more likely it is that depression is present.
The intervention lasted for 12 weeks, and the evaluations were carried out before exercise rehabilitation and after the 12-week intervention. All patients were followed up for 1 year, and were reevaluated then.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TaiChi trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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