Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation

Rehabilitation With CHF; NYHA Class I or II Clinical Trial

— BEPCR  

Official title:

Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation: A Prospective, Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03229681
• Other study ID #: 20170506
• Status: Recruiting
• Phase: N/A
• First received: July 23, 2017
• Last updated: July 23, 2017
• Start date: May 2, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: July 2017
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: Meili Yu
• Phone: +86(010)62835341
• Email: woshananyang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic heart failure (CHF) is the end stage of various kinds of cardiovascular diseases with high mortality. After a long period of medical treatment or surgical treatment, patients suffered great pain physically and mentally. How to improve the quality of life and prognosis in patients with CHF, which is a hot topic in the field of cardiac rehabilitation now. Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for CHF patients.

To investigate the efficacy and safety of Baduanjin exercise for patients with coronary heart disease complicated with chronic heart failure (CHF). A randomized, controlled and prospective clinical trial was designed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged from 40 to 75 years;

• Diagnosed with chronic heart failure caused by coronary heart disease;

• NYHA class I or II;

• Patients with an ejection fraction (LVEF) more than 40%;

• Participants in accordance with the guidelines define as stage II cardiac rehabilitation;

• Participants signed the informed consent freely and voluntarily.

Exclusion Criteria:

• The condition was serious or movement restrained by other diseases;

• In the acute stage of chronic heart failure;

• Participants with poorly control of blood pressure (SBP=180mmHg or DBP=100mmHg);

• Resting heart rate is beating over 120 beats a minute, or merged with malignant arrhythmia;

• Participants who have contraindications to cardiopulmonary test or exercise training;

• Patients who have other serious acute, chronic organic disease or mental disorders;

• Participants practiced in any kinds of traditional Chinese medicine exercises in last three months.

Related Conditions & MeSH terms

• Heart Failure
• Rehabilitation With CHF; NYHA Class I or II

Intervention

Behavioral:
• Baduanjin exercise
Participants in this groups received routine rehabilitation training and Baduanjin exercise. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. Baduanjin exercise protocol according to the "Health Qigong Baduanjin Standard" enacted by the General Administration of Sports in 2003. Due to the low-activity tolerance of CHF patients, we performed with a refined version of Baduanjin. Each Baduanjin exercise session lasts 45 minutes and continues twice per week for 12 weeks.
• Routine rehabilitation group
Participants in this qroup only received the routine rehabilitation training. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. They should also come to rehabilitation center for physical exercise,45 minutes per day,twice per week, lasts 12 weeks.

Locations

Country	Name	City	State
China	Xiyuan Hospital of China Academy of Chinese Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walk test(6MWT)	Testing patients changes on walking distance and accompanies symptoms in 6 minutes	Baseline, 3 months
Secondary	Cardiopulmonary exercise test (CPET)	CPET including peak VO2 (ml/kg/min), AT,VE/VCO2, et,al.	Baseline, 3 months
Secondary	Left ventricular ejection fraction(LVEF)		Baseline, 3 months
Secondary	Left ventricular end-diastolic diameter (LVDD)		Baseline, 3 months
Secondary	Minnesota living with heart failure questionnaire (MLHFQ)	Record the quality of life of patients with heart failure	Baseline, 3 months
Secondary	NT-proBNP		Baseline, 3 months
Secondary	hs-CRP		Baseline, 3 months
Secondary	HRV	Mainly includes SDANN Index, SDNN Index	Baseline, 3 months
Secondary	Major adverse cardiovascular events (MACE)	Defined as death, myocardial infarction (MI), stroke and re-hospitalization related to cardiovascular disease	Baseline, 3 months, 6months
Secondary	NYHA classification	The changes of heart function were compared after treatment	Baseline, 3 months, 6months
Secondary	The Main TCM symptoms	The changes of scores of TCM syndromes	Baseline, 3 months