Tai Chi Exercise in Patients with Heart Failure

NCT04445753 | Completed

• 1 other identifier: AIBU-HSF-SDEMIR-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nursing Caries; Heart Failure; Quality of Life

Keywords

heart failure; quality of life; Tai Chi

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3-months

Secondary Outcomes (2)

• Six-minute walking test (meter)

  3-months

• Quality of life

  3-months

Study Arms (2)

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.

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.

Behavioral: Education (control group)

Interventions

Tai Chi exercise OTHER

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.

Tai Chi program

Education (control group) BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University Izzet Baysal Training and Research Hospital

Bolu, Bolu, 14280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Aquatic Therapy; Educational Status; Control Groups

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Socioeconomic Factors; Population Characteristics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Şeyma Demir, Res. Assist.

  Bolu Abant Izzet Baysal University, Health Sciences Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assist

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 24, 2020
• Study Start: January 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: December 21, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)