Efficacy and safety of Tai Chi for rehabilitation after PCI in patients with coronary heart disease: A protocol of a randomized controlled trial

Phase 1

• Registration Number: TCTR20230101002
• Lead Sponsor: Huaying Wang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Last Update Posted: 19 August 2024
• Study Completion: 2025-02-11

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

(1) Meet the diagnosis of angina pectoris in CHD, and meet coronary angiography or coronary angiography showed at least one coronary artery stenosis and catheter stenosis no less than 50%, cardiac MRI or radionuclide myocardial perfusion imaging confirmed myocardial ischemia and ECG ST-T changes in patients with CHD;
(2) Stable condition after surgical treatment with PCI;
(3) Aged no less than 18 years, and be not more than 70 years, regardless of gender;
(4) limb joint activity is normal, can complete Tai Chi exercise;
(5) Patients voluntarily participate in the trial and sign informed consent.

Exclusion Criteria

(1) Patients with severe cardiopulmonary diseases such as dissection of aortic, severe aortic coarctation, aortic aneurysm, pulmonary embolism, pulmonary infarction;
(2) Patients with severe cardiac arrhythmia;
(3) Patients with severe liver and kidney dysfunction and severe hematopoietic system abnormalities, water electrolyte abnormalities and other diseases;
(4) Patients with severe mental illness who have difficulty cooperating;
(5) Pregnant or lactating women;
(6) Patients with uncontrolled infectious or non-infectious inflammatory diseases;
(7) Patients who cannot perform this exercise after professional evaluation;
(8) Subjects who are participating in clinical trials of other drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seattle Angina Questionnaire 24 weeks Five dimensions: the degree of restriction of physical activity, angina pectoris stable state, frequency of angina pectoris attack, satisfaction with treatment, and awareness of the disease.

Secondary Outcome Measures

Name	Time	Method
Cardiac function indicators 24 weeks left ventricular ejection fraction (LVEF) was measured by color doppler ultrasonic diagnostic apparatus