Tai Chi Exercise in Patients with Heart Failure (The Tai-Heart)

September 13, 2024 updated by: Seyma Demir, Abant Izzet Baysal University

Nurse-Guided Complementary Exercise for Cardiac Function Improvement in Heart Failure: Findings from the Tai-Heart RCT

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed 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.

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 (Actual)

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.
33

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 Locations

  • Turkey
      • Bolu, Turkey, 14280
        • Bolu Abant Izzet Baysal University Izzet Baysal Training and Research 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years and over,
  • Diagnosed as chronic heart failure by the physician,
  • Left ventricular ejection fraction (LVEF) <40%, proven by echocardiography in the past two years,
  • New York Heart Association (NYHA) class II and III,
  • Sinus rhythm is observed in electrocardiography (ECG),
  • Blood pressure values measured before Tai Chi session were 120-160 mmHg for systolic pressure and 80-110 mmHg for diastolic pressure,
  • No current anxiolytic or hypnotic treatment,
  • Have no psychiatric problems,
  • Verbal communication can be established,
  • Those who understand and speak Turkish,
  • No speech, hearing and vision loss,
  • There is no physical limitation that prevents the exercise of standing,
  • They have never experienced Tai Chi exercise before,
  • Individuals who volunteer to participate in the Tai Chi program during the study

Exclusion Criteria:

  • Having unstable angina pectoris, myocardial infarction or major cardiac surgery in the past three months,
  • Experiencing dyspnea and exercise tolerance that worsen during rest,
  • NYHA class I and IV,
  • Type B natriuretic peptide level measured in the last three months is 100 and above,
  • Blood pressure values measured before the Tai Chi session are> 120 mmHg or <160 mmHg for systolic pressure and> 80 mmHg or <110 mmHg for diastolic pressure,
  • Has hemodynamically significant heart valve disease,
  • Having dysrhythmia problems such as ventricular tachyarrhythmia, atrial fibrillation,
  • Has a history of cardiac resynchronization therapy in the past 3 months,
  • Having chronic diseases such as chronic pulmonary disease and renal failure,
  • With uncontrolled diabetes (Hemoglobin A1C ≥ 7 mg / dl),
  • Diagnosed with thrombophlebitis,
  • Has a history of cardiac transplantation and cardiac device therapy (cardiac pacemaker, implantable cardioverter defibrillator),
  • Having physical limitations that prevent standing exercise,
  • Do not understand and speak Turkish,
  • Speech, hearing and vision loss,
  • Individuals who do not volunteer to participate in the Tai Chi program during the study

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Tai Chi program
Individuals in the intervention group will perform a 12-week Tai Chi exercise in company with a researcher.Following the warm-up movements (Qi-gong), the training protocol of the Tai Chi movements, which includes the 10-form Yang style, will continue for 12 weeks, with two sessions per week determined by the researchers.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. For 12 weeks, individuals will practice 10 forms of Tai Chi exercises with a researcher in each session. Each session will be planned as one hour.
Other: Tai Chi exercise
Individuals in the intervention group will perform a 12-week Tai Chi exercise in company with a researcher.Following the warm-up movements (Qi-gong), the training protocol of the Tai Chi movements, which includes the 10-form Yang style, will continue for 12 weeks, with two sessions per week determined by the researchers.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. For 12 weeks, individuals will practice 10 forms of Tai Chi exercises with a researcher in each session. Each session will be planned as one hour.
Other: Control group
Individuals in the control group will be trained on heart failure. The only attempt to be made to the control group will be education.
Behavioral: Education (control group)
Individuals in the control group will also be trained on heart failure, which will be applied to individuals in the intervention group. The only attempt to be made to the control group will be education.

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
Pro-BNP levels (pg/ml)
Time Frame: 3-months
Biomarker to be used to estimate the prognosis of heart failure. The blood taken into 2ml EDTA tubes will be studied.
3-months
Transthoracic Echocardiography measurements
Time Frame: 3-months
Transthoracic echocardiography will be performed to each individual and multiple criteria will be evaluated.In two-dimensional echocardiographic examination, left ventricular ejection fraction will be evaluated by M-mod and Simpson methods.
3-months

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
Six-minute walking test (meter)
Time Frame: 3-months
It is a widely used test that can be easily applied in evaluating functional capacity and treatment response in individuals with cardiopulmonary disease.During the test, patients are asked to walk as fast as they can without running, and the total distance they walk after 6 minutes is measured.
3-months
Quality of life
Time Frame: 3-months
Left Ventricular Dysfunction Scale 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. The questions of the 36-item scale are presented to the patients with two options as true and false. The "true" answers given are added together and the total number of "true" answers found is expressed as a percentage. The minimum and maximum scores that can be obtained from the scale range from 0 to 100, and as the score increases, the quality of life decreases. In this study, a questionnaire will be applied initially and after 12 weeks.
3-months

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.
Abant Izzet Baysal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Şeyma Demir, Res. Assist., Bolu Abant Izzet Baysal University, Health Sciences Faculty

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 (Actual)

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, 2020

Primary Completion (Actual)

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.
April 1, 2021

Study Completion (Actual)

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 21, 2021

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).
May 29, 2020

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.
June 21, 2020

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.
June 24, 2020

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.
September 19, 2024

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.
September 13, 2024

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.
September 1, 2024

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.
  • AIBU-HSF-SDEMIR-01

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

product manufactured in and exported from the U.S.

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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