Effectiveness and Safety of Exercise-based Cardiac Rehabilitation (ExCR) During the Vulnerable Period in Patients with Acute Decompensated Heart Failure (ADHF): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in the 6-minute walking test distance
研究概览
简要总结
Exercise-based cardiac rehabilitation has become a key component of the comprehensive care system for patients with stable heart failure (HF). However, due to hemodynamic instability and functional decline in early ADHF, most HF rehab studies exclude current/recent ADHF exacerbations. Currently, ADHF management strategies lack robust evidence, and the timing, duration, and frequency of exercise interventions need further validation globally.
This study aims to address the following issues:
Develop an exercise management program for ADHF patients, verify its feasibility, and determine the safety and applicability of early exercise rehabilitation; Evaluate the improvement of participants in terms of physical function, cardiac function, and quality of life.
The research team will compare the formulated exercise rehabilitation program with conventional rehabilitation guidance to verify its feasibility and effectiveness.
Participants will:
Physicians and rehabilitation therapists will comprehensively assess the participants' conditions to determine the start time of rehabilitation training. Based on the patients' cardiac function, muscle strength, and heart failure-related clinical indicators, rehabilitation training is divided into two stages (the first stage is early in-hospital training, and the second stage is self-directed training after discharge). Exercise types mainly include respiratory training, bed activities, rehabilitation pedaling, and resistance training. Rehabilitation therapists and nurses will monitor participants' vital signs during the exercise process and choose the appropriate exercise intensity based on the participants' level of fatigue.
The exercise rehabilitation program will be evaluated and adjusted every two weeks for a total period of 12 weeks.
At the time of enrollment, discharge, two weeks after discharge, and four weeks after discharge, participants will need to complete questionnaires, including demographic and disease condition surveys, grip strength tests, Activities of Daily Living (ADL) scales, Short Physical Performance Battery (SPPB) scales, Minnesota Living with Heart Failure Questionnaire (MLHFQ) scales, and 6-minute walk tests, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Hospitalized for ADHF for over 24 hours.
- •Age 18-80 years.
- •At least one acute heart failure symptom: dyspnea at rest or exertion, fatigue, orthopnea, or paroxysmal nocturnal dyspnea.
- •At least two heart failure signs: confirmed pulmonary congestion or edema on exam or chest X-ray, jugular venous distension, peripheral edema, rapid weight gain (>2 kg in 3 days), or elevated BNP (≥100 ng/L) and NT-proBNP (≥300 ng/L).
- •Change in heart failure treatment plan with initiation or increased dosage of: diuretics, vasodilators, positive inotropic agents (e.g., digoxin), or other neurohormonal modulators (ACEI/ARB/ARNI, β-blocker, MRA).
排除标准
- •Indications for urgent cardiovascular surgery (e.g., heart transplantation, left ventricular assist device).
- •Cardiogenic shock.
- •Recent deep vein thrombosis.
- •Severe cardiovascular diseases (e.g., severe aortic stenosis, mitral regurgitation).
- •GFR <30 ml/min or need for dialysis during the study.
- •Severe COPD (FEV1/FVC <0.7 post-bronchodilator, with severe defined as 30% ≤ FEV1 <50% predicted, and very severe as FEV1 <30% predicted).
- •Severe frailty (Clinical Frailty Scale CFS ≥7).
- •Mental, psychological, cognitive disorders, or substance dependence.
研究组 & 干预措施
Experimental group
Exercise rehabilitation
干预措施: Exercise rehabilitation (Behavioral)
Control group
Conventional rehabilitation
干预措施: Conventional rehabilitation (Behavioral)
结局指标
主要结局
Change in the 6-minute walking test distance
时间窗: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Assess the changes in participants' 6MWT distance at baseline and 1, 2, and 3 months post-discharge.
次要结局
- Left Ventricular Ejection Fraction （LVEF%）(From enrollment to the end of the 12-week exercise rehabilitation intervention.)
- Brain Natriuretic Peptide（BNP）(From enrollment to the end of the 12-week exercise rehabilitation intervention.)
- NYHA class(From enrollment to the end of the 12-week exercise rehabilitation intervention.)
- Grip strength(From enrollment to the end of the 12-week exercise rehabilitation intervention.)
- Length of hospitalization(From hospitalization to discharge, an average of 12 weeks.)
- Short Physical Performance Battery（SPPB）(From enrollment to the end of the 12-week exercise rehabilitation intervention.)
- Activities of Daily Living（ADL）(From enrollment to the end of the 12-week exercise rehabilitation intervention.)
- Quality of life using MLHFQ scale(From enrollment to the end of the 12-week exercise rehabilitation intervention.)
- Degree of frailty.(From enrollment to the end of the 12-week exercise rehabilitation intervention.)
研究者
YE Jing
Chief Nurse of the Cardiovascular Intensive Care Unit
Peking University First Hospital