Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT05178602
Status:
UNKNOWN
Last Update Posted:
2022-01-05
First Post:
2021-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of TaiChi on Ischemic Burden of Patients With Coronary Heart Disease Complicated With Renal Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 142}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2021-11-27', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nuclein myocardial perfusion Imaging-total scores of stress perfusion（SSS）', 'timeFrame': '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.', 'description': 'The total load perfusion score indicates the extent and severity of abnormal exercise perfusion. Higher scores indicate more severe myocardial ischemia.'}, {'measure': 'Nuclein myocardial perfusion Imaging-total scores of rest perfusion（SRS）', 'timeFrame': '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.', 'description': 'The total resting perfusion score (SRS) refers to the degree of myocardial ischemia at rest, with higher scores indicating more severe myocardial ischemia.'}, {'measure': 'Nuclein myocardial perfusion Imaging-Total myocardial ischemia score', 'timeFrame': '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.', 'description': 'The total myocardial ischemia score reflects the extent and severity of exercise-induced ischemia, with higher scores indicating more severe myocardial ischemia.'}, {'measure': 'Left ventricular ejection fraction difference（△LVEF）', 'timeFrame': '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.', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Cardiopulmonary exercise test-Peak oxygen uptake (PVO2)', 'timeFrame': '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.', 'description': '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).'}, {'measure': 'Cardiopulmonary exercise test-Oxygen uptake to power ratio（ΔVO2/ΔＷＲ）', 'timeFrame': '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.', 'description': 'The lower the oxygen uptake to power ratio, the worse the cardiorespiratory function.The unit is mL/(min·W) .'}, {'measure': 'Cardiopulmonary exercise test-Metabolic equivalents (MET)', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Cardiopulmonary exercise test-Carbon dioxide ventilation equivalent（VE/VCO2）', 'timeFrame': '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.', 'description': 'The higher the ratio of VE/VCO2, the lower the ventilation efficiency'}, {'measure': 'Total serum cholesterol(TC)', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'High-density lipoprotein cholesterol (HDL-C)', 'timeFrame': '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.', 'description': 'The higher the HDL cholesterol in the blood, the better it is for the cardiovascular system.'}, {'measure': 'Low-density lipoprotein cholesterol (LDL-C)', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Triglycerides (TG)', 'timeFrame': '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.', 'description': 'Triglycerides is one of the risk factors for coronary heart disease, and the higher the triglycerides level, the worse it is for cardiovascular.'}, {'measure': 'Body Mass Index(BMI)', 'timeFrame': '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.', 'description': '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.'}, {'measure': 'Assess the quality of life', 'timeFrame': '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.', 'description': "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."}, {'measure': 'Self-rating anxiety scale(SAS)', 'timeFrame': '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.', 'description': 'The higher the score on the self-rating scale of anxiety, the more likely it is that anxiety is present.'}, {'measure': 'Self-Rating Depression scale(SDS)', 'timeFrame': '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.', 'description': 'The higher the score on the self-rating scale of anxiety, the more likely it is that depression is present.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CHD', 'PCI', 'Tai Chi', 'Renal Insufficiency', 'Cardiac rehabilitation'], 'conditions': ['Coronary Heart Disease (CHD)', 'Renal Insufficiency']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 30-75 years old, all genders;\n2. At least two main vessels or their main branch vessels have obvious stenosis (≥50%) according to the coronary angiography;\n3. 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);\n4. eGFR\\<60ml/min·1.73m2;\n5. Willing to be treated and followed-up during the specified time of the study;\n6. Signed the informed consent approved by the Ethics Committee\n\nExclusion Criteria:\n\n1. Patients with high-risks according to the exercise rehabilitation risks of patients with heart disease by AACVPR;\n2. Severe cardiac insufficiency or cardiogenic shock;\n3. Combined with severe ventricular arrhythmia, ICD is required;\n4. Combined with severe pulmonary hypertension, chronic obstructive pulmonary disease, severe infectious disease, blood system disease, malignant tumor, severe liver damage, etc.;\n5. Nervous, mental and motor system diseases;\n6. Unwilling to be followed-up.'}, 'identificationModule': {'nctId': 'NCT05178602', 'briefTitle': 'The Effect of TaiChi on Ischemic Burden of Patients With Coronary Heart Disease Complicated With Renal Insufficiency', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'The Effect of TaiChi on Ischemic Burden of Patients With Coronary Heart Disease Complicated With Renal Insufficiency', 'orgStudyIdInfo': {'id': 'TaiChi trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The experimental group', 'description': 'Routine treatment, and tai Chi exercise,5 times a week', 'interventionNames': ['Behavioral: Tai Chi Intervention Group']}, {'type': 'NO_INTERVENTION', 'label': 'The control group', 'description': 'Routine treatment, and cardiac rehabilitation is not mandatory'}], 'interventions': [{'name': 'Tai Chi Intervention Group', 'type': 'BEHAVIORAL', 'description': 'Tai Chi intervention group: routine treatment and tai Chi exercise,5 times a week.', 'armGroupLabels': ['The experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'JI Huang, Doctor', 'role': 'CONTACT', 'email': 'drjihuang@163.com', 'phone': '15810291548'}, {'name': 'Chu Fan, Postgraduate', 'role': 'CONTACT', 'email': 'fc19970915@Foxmail.com', 'phone': '+8618832070253'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ji Huang', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}