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

NCT ID: NCT03229681

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2018-12-30

Brief 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.

Conditions

Rehabilitation With CHF; NYHA Class I or II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Baduanjin exercise group

Participants in this group received routine rehabilitation training and Baduanjin exercise

Group Type: EXPERIMENTAL

Baduanjin exercise

Intervention Type: BEHAVIORAL

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 group only received routine rehabilitation training

Group Type: ACTIVE_COMPARATOR

Routine rehabilitation group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Routine rehabilitation

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hao Xu

Role: STUDY_DIRECTOR

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Locations

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Meili Yu

Role: CONTACT

woshananyang@163.com

+86(010)62835341

Facility Contacts

Meili Yu

Role: primary

woshananyang@163.com

+86(010)62835341

References

Yu M, Li S, Li S, Li J, Xu H, Chen K. Baduanjin exercise for patients with ischemic heart failure on phase-II cardiac rehabilitation (BEAR trial): study protocol for a prospective randomized controlled trial. Trials. 2018 Jul 16;19(1):381. doi: 10.1186/s13063-018-2759-4.

Reference Type: DERIVED

PMID: 30012193 (View on PubMed)

Other Identifiers

20170506

Identifier Type: -

Identifier Source: org_study_id