About this trial
EACH-ADHF: Early Comprehensive Rehabilitation in patients with ADHF study is a multi-center, parallel-group, randomized controlled trial designed to evaluate the effects of the early comprehensive rehabilitation including exercise and inspiratory muscle training, over a period of 6 weeks, on the quality of life of patients with ADHF.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18-80
Able to independently perform basic activities of daily living before admission.
Able to complete the baseline assessment and initiate the specified treatment.
Able to walk 4 meters at the time of enrollment (assistive devices may be used).
Disqualifiers
Acute heart failure caused by acute myocardial infarction.
Severe aortic valve stenosis.
Hemodynamic instability caused by poorly controlled arrhythmias.
Severe heart failure and high-degree atrioventricular block, and inadequate heart rate response to pacing during exercise.
Trial design
Parallel
Treatments tested in this trial
Early comprehensive rehabilitation
BehavioralPatients randomized to the rehabilitation intervention group will be offered comprehensive rehabilitation plan containing 18 sessions of a structured outpatient-based exercise program over 6 weeks (3 times per week).
Treatment groups
Trial outcomes
Primary outcomes
Score of Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Maximal Inspiratory Pressure as a Percentage of Predicted Value (PImax%pred)
Participants will tries their best to exhale to the residual position, and then inhale as much as possible for 2\~3 seconds to measure PImax and the percentage of PImax%pred
Secondary outcomes
Score of Short Physical Performance Battery (SPPB)
The SPPB measures physical function using 3 components: standing balance with progressively narrow base of support, usual gait speed over 4 meters, and time to complete 5 chair rises. The total score ranges from 0 to 12, with higher scores indicating better physical function.
Score of Frailty
Patients were classified as frail if they met three or more of the following criteria: weak grip strength, physical exhaustion, slowness, low physical activity and unintentional weight loss.
Pulmonary Function
Measurements of forced vital capacity and forced expiratory volume in 1 s were obtained with a computerized spirometer.
Rate of All-Cause Rehospitalization
Number of all-cause rehospitalizations 6 months from hospital discharge.
Other outcomes
Score of Quality of Life Measured by Short Form 12 Item Questionnaire (SF-12)
The SF-12 is a quality of life assessment with 2 component scores (Physical Composite Score and Mental Composite Score) ranging 0-100 with higher scores indicating better health status.
Score of Anxiety
Anxiety is assessed by General Anxiety Disorder-7. Score ranges from 0 to 21 points, with higher scores indicating more severe anxiety.
Score of Depression
Depression is assessed by Patient Health Questionnaire-9. Score of Patient Health Questionnaire-9 ranges from 0 to 27 points, with higher scores indicating more severe mood depression.
Left ventricular ejection fraction (LVEF)
Using Echocardiography to assess the left ventricular ejection fraction (LVEF)
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