Rehabilitation With CHF; NYHA Class I or II
Conditions
Keywords
Baduanjin; CHF; 6MWT; CPET
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.
Interventions
BEHAVIORALBaduanjin 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.
BEHAVIORALRoutine 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.
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute walk test（6MWT） | Baseline, 3 months | Testing patients changes on walking distance and accompanies symptoms in 6 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular ejection fraction（LVEF） | Baseline, 3 months | — |
| Left ventricular end-diastolic diameter (LVDD) | Baseline, 3 months | — |
| Minnesota living with heart failure questionnaire (MLHFQ) | Baseline, 3 months | Record the quality of life of patients with heart failure |
| NT-proBNP | Baseline, 3 months | — |
| Cardiopulmonary exercise test (CPET) | Baseline, 3 months | CPET including peak VO2 (ml/kg/min)， AT，VE/VCO2, et,al. |
| HRV | Baseline, 3 months | Mainly includes SDANN Index, SDNN Index |
| Major adverse cardiovascular events (MACE) | Baseline, 3 months, 6months | Defined as death, myocardial infarction (MI), stroke and re-hospitalization related to cardiovascular disease |
| NYHA classification | Baseline, 3 months, 6months | The changes of heart function were compared after treatment |
| The Main TCM symptoms | Baseline, 3 months | The changes of scores of TCM syndromes |
| hs-CRP | Baseline, 3 months | — |
Countries
China
Contacts
Primary ContactMeili Yu
Outcome results
None listed