Tai Chi Program in Patients With Heart Failure

Heart Failure Clinical Trial

Official title: Effect of Tai Chi Program on Cardiac Functions and Quality of Life in Patients With Heart Failure: A Randomized Controlled Trial

Status Completed

Clinical Trial Summary

Aim: The aim of the present study is to examine with B-type natriuretic peptide (pro-BNP) and echocardiographic parameters and to measure life quality the effects of the 12-week Tai-Chi exercise program on cardiovascular responses in patients with heart failure in Turkey. In addition, four basic research questions have been identified for the purpose of the research:

Methods:Randomized controlled trial will be carried out in the cardiology outpatient clinic in Turkey. The research will include two groups, an intervention (n=23) and a control (n=23). Cardiovascular responses will be measured with Pro-BNP, transthoracic echocardiography and six minutes walking test; Quality of life measurements with Left Ventricular Dysfunction Scale (LVD-36).Tai-Chi exercises will be carried out for a total of 12 weeks, with 2 sessions each week and one hour each session for intervention group. In addition, initially, approximately 45 minutes of heart failure education will be given to both the intervention and control groups.

Clinical Trial Description

The aim of the present study is to examine with B-type natriuretic peptide (pro-BNP) and echocardiographic parameters and to measure life quality the effects of the 12-week Tai-Chi exercise program on cardiovascular responses in patients with heart failure in Turkey. In addition, four basic research questions have been identified for the purpose of the research:

1. Methods:

1.1. Design: Randomized controlled trial. 1.2. Setting: The research will be carried out in the cardiology outpatient clinic of Izzet Baysal Training and Research Hospital, Bolu, Turkey.

1.3. Sample: The research will include two groups, an intervention and a control. Power analysis was used to determine the sample size. The sample of 46 (intervention=23, control=23) was sufficient with 0.86 effect size, 95% confidence interval and 80% power. In randomization, closed envelope method will be used.

1.4. Data collecting

1.4.1. Patient Information Form: data regarding demographic and clinical features will be collected.

1.4.2. Cardiovascular responses

1.4.2.1. Pro-BNP Measurements: Pro-BNP levels will be studied from venous blood samples taken for each individual before the study (pre-test) and after 12 weeks (post-test). Blood samples will be taken at least 2 cc into ethylenediamine tetraacetic acid (EDTA) tubes between 8:00 am and 9:00 am after 12 hours of fasting; "Fluorescence immunoassay" method will be used by using "Architect BNP Test" kit.

1.4.2.2. Transthoracic Echocardiography Measurements: In this study, all individuals will receive transthoracic echocardiography twice before the study (pre-test) and after 12 weeks (post-test). Transthoracic echocardiographic examination will be performed with the Philips EPIQ 7 echocardiography device and Philips X5-1 xMatrix 3.5 MHz access probe in the reclining position while resting. Measurements will be made according to the American Echocardiographic Association criteria. In two-dimensional echocardiographic examination, parasternal long / short axis, ventricular wall movements, valve structures and functions will be assessed in apical four chamber views; interventricular septum thickness (IVSd), posterior wall thickness (PWd), left ventricular diastolic and systolic inner diameters (LVIDd / s) will be measured. Left ventricular ejection fraction(LVEF) will be evaluated by M-mod and Simpson methods. Evaluation of diastolic functions will be assessed by transmitral pulse wave and tissue doppler examinations, right ventricular basal and mid diameters will be measured at the end of diastole. Tricuspid annular plane systolic excursion (TAPSE) and S-wave measurements will be performed to evaluate the right ventricular systolic functions. Using the Lacobelli method, epicardial fat thickness measurements will be performed.

1.4.2.3. Six minutes walking test: A starting and ending point (30 meters distance) will be determined and all participants will be asked to walk for 6 minutes between this distance and the total distance they walked will be calculated and recorded. This test will be repeated both at baseline (pretest) and after 12 weeks (posttest).

1.4.2.4. Quality of life measurements: Left Ventricular Dysfunction Scale (LVD-36) is a disease-specific quality of life scale developed by Leary and Jones (2000) to measure the quality of life in patients with heart failure.Scores between 0 and 100 are obtained from the scale and the quality of life decreases as the score obtained increases (Leary and Jones, 2000; Özer & Argon, 2005).In this study, the scale will be administered to individuals at the beginning (pre-test) and 12 weeks later (post-test).

1.4.3. Interventions: Tai-Chi exercises will be carried out for a total of 12 weeks, with 2 sessions each week and one hour each session. In addition, initially, approximately 45 minutes of heart failure education will be given to both the intervention and control groups.

1.4.3.1. Tai-Chi procedure: Tai Chi movements will include the 10-form Yang style following the warm up movements (Qi-gong). The first and second weeks of the exercise protocol will include introducing the Tai Chi philosophy and teaching 10 forms of Yang style to patients. During the 12 weeks, individuals will practice 10 forms of Tai Chi exercises with a researcher in each session.

1.4.3.2.Education protocol on heart failure: The scope of the education will include lifestyle changes, such as nutrition, exercise, weight management, smoking and inappropriate alcohol consumption, which are prepared by the researcher in the light of both literature information and evidence based information in the ESC diagnosis and treatment guide for heart failure. The education method will be reflected on the projection both on verbal expression and computer screen, and will be in the form of visual demonstration with visual materials. ;

Related Conditions & MeSH terms

• Heart Failure
• Nursing Caries
• Quality of Life

• NCT number: NCT04445753
• Study type: Interventional
• Source: Abant Izzet Baysal University
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Completion date: December 21, 2021