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).
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- 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.
- Conditions
- Nursing Caries, Heart Failure, Quality of Life
- 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 group | Role | What they receive |
|---|---|---|
| Tai Chi program | Experimental | 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. Receives: Other: Tai Chi exercise |
| Control group | Other | Individuals 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.
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
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)
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
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 \"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.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Jan 2020
- Primary completion1 Apr 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Demir, Abant Izzet Baysal University
- Investigators
- Şeyma Demir, Res. Assist., Principal investigator, Bolu Abant Izzet Baysal University, Health Sciences Faculty
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Guided Complementary Exercise for Cardiac Function Improvement in Heart Failure: Findings from the Tai-Heart RCT
- ClinicalTrials.gov ID
- NCT04445753
- Acronym / sponsor ID
- The Tai-Heart / AIBU-HSF-SDEMIR-01
- Conditions
- Nursing Caries, Heart Failure, Quality of Life
- Keywords
- heart failure, quality of life, Tai Chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi program | Experimental | Other: Tai Chi exerciseIndividuals 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. |
| Control group | Other | Behavioral: Education (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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),
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi exerciseIndividuals 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 program |
| 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. | Behavioural | Control group |
Primary outcome
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.
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.
2 secondary outcomes
Six-minute walking test (meter)
Time frame: 3-months
Quality of life
Time frame: 3-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şeyma Demir, Res. Assist. principal investigator
Bolu Abant Izzet Baysal University, Health Sciences Faculty
1 site in 1 country: see every site and its status.
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.