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Nursing CariesThe Tai-HeartNCT04445753

Tai Chi Exercise in Patients with Heart Failure

A study testing Tai Chi exercise in people with Nursing Caries and Heart Failure, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nursing Caries, Heart Failure, Quality of Life
What is being tested?
Tai Chi exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2020to 21 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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

Who cannot join

  • 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,
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  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bolu Abant Izzet Baysal University Izzet Baysal Training and Research Hospital

    Bolu, Bolu, 14280

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Tai Chi exercise, Education (control group)
Keywords
heart failure, quality of life, Tai Chi
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tai Chi exerciseOther

    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.

  • Education (control group)Behavioural

    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.

Study groups in NCT04445753
Study groupRoleWhat they receive
Tai Chi programExperimentalIndividuals 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.
Receives: Other: Tai Chi exercise
Control groupOtherIndividuals in the control group will be trained on heart failure. The only attempt to be made to the control group will be education.
Receives: Behavioral: Education (control group)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pro-BNP levels (pg/ml)

    Biomarker to be used to estimate the prognosis of heart failure. The blood taken into 2ml EDTA tubes will be studied.

    Measured: 3-months

  2. Transthoracic Echocardiography measurements

    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.

    Measured: 3-months

Secondary outcomes (2)
  1. Six-minute walking test (meter)

    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.

    Measured: 3-months

  2. Quality of life

    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 \&#34;true\&#34; answers given are added together and the total number of \&#34;true\&#34; 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.

    Measured: 3-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2020
  2. Study start1 Jan 2020
  3. Primary completion1 Apr 2021
  4. Study completion21 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04445753
Sponsor's protocol ID
AIBU-HSF-SDEMIR-01
Acronym
The Tai-Heart
Status last verified
Sep 2024
First submitted
29 May 2020
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tai Chi exercise in people with Nursing Caries and Heart Failure, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pro-BNP levels (pg/ml) (time frame: 3-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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