Efficacy and Safety of Early Comprehensive Rehabilitation in Patients With ADHF, A Multicenter, Randomized, Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Score of Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
研究概览
简要总结
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.
详细描述
Guangdong Provincial People's Hospital will be the lead center, with an additional 8 hospitals designated as satellite centers for the study. To sum up, these centers will recruit a total of 140 consenting patients. Following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a 6-week progressive, comprehensive exercise training and inspiratory muscle training or attention control.
The intervention group will receive an 6-week exercise program consisting of endurance, resistance, balance, mobility, and inspiratory muscle training. The comprehensive rehabilitation will begin during the patient's stay and continue to the outpatient clinic. The control group will receive usual care with bi-weekly contact from study personnel. The primary outcomes of the study are improvements in the summary score of KCCQ and PImax%pred, while secondary endpoints include the impact on physical function, cardiac function, psychological status, and major adverse cardiovascular events (MACE). Additionally, the study will also explore the effects of comprehensive rehabilitation on hospital readmission and mortality rates, with follow-up assessments planned up to 6 months after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-80
- •At least one symptom of heart failure upon admission:
- •Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue.
- •At least two of the signs of heart failure (HF):
- •Distended jugular veins, enlarged cardiac silhouette, apex beat displacement, third heart sound, or increased jugular venous pressure/central venous pressure/pulmonary capillary wedge pressure.
- •Pulmonary edema or pulmonary congestion (rales or chest X-ray/CT evidence of pulmonary congestion).
- •Peripheral edema. Elevated B-type natriuretic peptide (>100 pg/ml) or elevated NT-proBNP (>300 pg/ml).
- •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).
- •Agree to participate in this study, sign a written informed consent form, and is willing to cooperate with follow-up.
排除标准
- •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.
- •Isolated pulmonary hypertension.
- •Poorly controlled symptomatic orthostatic hypotension.
- •Hypertrophic obstructive cardiomyopathy.
- •Stage 5 chronic kidney failure, defined as glomerular filtration rate <15 ml/(min·1.73m²) or requiring dialysis.
- •Undergoing screening tests with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than or equal to 5 times the upper limit of the normal range defined by the center.
- •Awaiting a heart transplant or ventricular assist device implantation within six months, or having received a heart transplant.
- •A history of chronic lung disease except for COPD, previous lung surgery, or diseases affecting lung function, such as scoliosis.
- •Late-stage diseases other than heart failure.
- •Any medical history that could potentially affect protocol compliance, such as severe mental disorders, severe cognitive impairment, substance abuse, or addiction.
- •Severe language, psychological, or physical disabilities that prevent their participation in the program.
- •Pregnant or lactating women, or those of childbearing potential who are unwilling or unable to use effective contraceptive measures.
- •Involved in other interventional clinical trials.
- •Patients deemed unfit for participation in this study by the researchers.
结局指标
主要结局
Score of Quality of Life Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
时间窗: Baseline and Week 6
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)
时间窗: Baseline and Week 6
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
次要结局
- Score of Frailty(Baseline and Week 6)
- Pulmonary Function(Baseline and Week 6)
- Rate of All-Cause Rehospitalization(Month 6)
- Score of Short Physical Performance Battery (SPPB)(Baseline and Week 6)
研究者
Lan Guo
Chief Physician of Cardiology, Director of the Department of Cardiac Rehabilitation
Guangdong Provincial People's Hospital