Efficacy and Safety of Home-Based Exercise Rehabilitation in Patients With Cardiorenal Syndrome Complicated by Chronic Heart Failure With Reduced Ejection Fraction (HFrEF): 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
- 60
- 主要终点
- Difference in VO₂ peak (a marker of cardiopulmonary exercise tolerance) between the two groups before and after 6 months of treatment
研究概览
简要总结
This study aims to investigate the efficacy and safety of exercise rehabilitation in patients with cardiorenal syndrome (CRS).
Building on previous research demonstrating that exercise rehabilitation can effectively improve cardiac function and cardiopulmonary endurance in patients with chronic heart failure, this study will further explore its role in the context of CRS, a condition where such effects remain understudied. CRS patients typically exhibit reduced cardiopulmonary endurance, with significantly lower peak oxygen uptake (VO₂ peak) and 6-minute walk test (6MWT) distance compared to non-CRS patients.
Adults aged 18-75 with chronic heart failure with reduced ejection fraction (HFrEF) complicated by chronic renal insufficiency will be enrolled and randomly assigned to two groups: 1. Basic treatment group: 30 patients receive only basic drug treatment for 6 months. 2. Exercise rehabilitation group: 30 patients receive basic drug treatment combined with home-based exercise rehabilitation for 6 months (with personalized exercise prescriptions formulated based on cardiopulmonary exercise test results or 6MWT for those unable to complete the former). The study will explore the efficacy and safety of exercise rehabilitation in the prevention and management of CRS by comparing changes in target biomarkers, renal function indicators, cardiac function indicators, cardiopulmonary exercise test results, Minnesota Living with Heart Failure Questionnaire scores, and the incidence of adverse events before and after treatment between the two groups.
The participants will:
Complete cardiopulmonary exercise tests or 6MWT before treatment initiation. Receive basic drug treatment; those in the exercise rehabilitation group will additionally perform home-based exercise rehabilitation according to the exercise prescription.
Attend regular follow-up visits within 6 months. Undergo assessments of related indicators (biomarkers, renal function, cardiac function, etc.) before and after treatment.
详细描述
This study is designed to evaluate the efficacy and safety of home-based exercise rehabilitation as an adjuvant intervention for patients with Cardiorenal Syndrome (CRS) complicated by Chronic Heart Failure with Reduced Ejection Fraction (HFrEF). Building on prior evidence that exercise rehabilitation improves cardiac function and cardiopulmonary endurance in patients with uncomplicated chronic heart failure, this study addresses a critical gap: the lack of data on how such interventions perform in CRS, a condition characterized by bidirectional cardiorenal impairment that often exacerbates both cardiac and renal dysfunction.
CRS patients with HFrEF typically exhibit reduced cardiopulmonary reserve, as evidenced by lower peak oxygen uptake (VO₂ peak) and 6-minute walk test (6MWT) distance compared to non-CRS patients. This impairment is driven by intertwined pathophysiological mechanisms, including neurohormonal activation, systemic inflammation, and reduced renal clearance of cardiotoxic metabolites-factors that may be modulated by structured exercise. The home-based exercise approach is selected for its clinical relevance: it aligns with long-term patient adherence (avoiding barriers to clinic-based training, such as transportation or scheduling) and allows for personalized intensity adjustments, a key safety consideration in patients with dual organ dysfunction.
Exercise prescriptions for the intervention group are tailored using a two-step assessment protocol to ensure safety and individualization:
- Cardiopulmonary Exercise Test (CPET): For patients able to complete CPET (per exercise risk assessment), the anaerobic threshold (AT) is identified via gas exchange analysis (using a metabolic cart). Exercise intensity is set at 60-70% of the heart rate corresponding to AT (HR-AT)-a range validated to improve cardiopulmonary endurance without inducing excessive cardiac or renal stress in HFrEF patients.
- 6MWT Alternative: For patients unable to complete CPET (e.g., due to severe dyspnea or fatigue), exercise intensity is derived from 6MWT results. The target walking speed is set at 70-80% of the average speed achieved during the 6MWT, with duration adjusted to match energy expenditure levels equivalent to the CPET-derived protocol.
The 6-month exercise program focuses on aerobic training (e.g., brisk walking, stationary cycling) with progressive adjustments: initial sessions are 20-30 minutes, 3 times weekly, with 5-10 minute increments in duration (up to 45 minutes) and 5-10% increments in intensity every 2 weeks, based on patient-reported tolerance (assessed via the Borg Rating of Perceived Exertion scale, 0-10) and monthly follow-up monitoring.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronically stable HFrEF complicated by kidney dysfunction (eGFR < 90 mL/min/1.73m²)
- •NYHA class II-III
- •Low risk in exercise risk assessment
- •Aged 18-75 years
排除标准
- •Uncontrolled hypertension
- •Severe arrhythmias (including frequent ventricular premature contractions, ventricular tachycardia, rapid atrial fibrillation, sick sinus syndrome, and second-degree or higher atrioventricular block)
- •Obstructive hypertrophic cardiomyopathy
- •Moderate to severe stenotic valvular heart disease
- •Deep vein thrombosis or pulmonary embolism
- •History of syncope
- •Severe anemia
- •Abnormal thyroid function
- •Severe pulmonary diseases
- •Mental illnesses
- •Osteoarticular or muscular diseases that impede rehabilitation training
研究组 & 干预措施
Basic Treatment Group
Patients with HFrEF and chronic kidney dysfunction receive 6 months of basic drug treatment, with regular follow-up during the period.
干预措施: Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction (Drug)
Exercise Rehabilitation Group
Patients with HFrEF and chronic kidney dysfunction receive 6 months of basic drug treatment combined with home-based exercise rehabilitation. Exercise prescriptions are formulated based on cardiopulmonary exercise test results (using heart rate at anaerobic threshold) or 6MWT (for those unable to complete cardiopulmonary exercise tests), with follow-up conducted throughout the period.
干预措施: Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction (Drug)
Exercise Rehabilitation Group
Patients with HFrEF and chronic kidney dysfunction receive 6 months of basic drug treatment combined with home-based exercise rehabilitation. Exercise prescriptions are formulated based on cardiopulmonary exercise test results (using heart rate at anaerobic threshold) or 6MWT (for those unable to complete cardiopulmonary exercise tests), with follow-up conducted throughout the period.
干预措施: Home-based Personalized Exercise Rehabilitation (Behavioral)
结局指标
主要结局
Difference in VO₂ peak (a marker of cardiopulmonary exercise tolerance) between the two groups before and after 6 months of treatment
时间窗: At baseline and 6 months after treatment initiation.
Compare the change in peak oxygen uptake (VO₂ peak, unit: mL/kg/min) between the Exercise Rehabilitation Group and the Basic Treatment Group. VO₂ peak will be measured via cardiopulmonary exercise test at baseline (before treatment initiation) and 6 months after treatment initiation to assess changes in cardiopulmonary exercise tolerance.
Difference in 6-minute walk test (6MWT) distance (a marker of cardiopulmonary exercise tolerance) between the two groups before and after 6 months of treatment
时间窗: At baseline and 6 months after treatment initiation.
Compare the change in 6MWT distance (unit: meters) between the Exercise Rehabilitation Group and the Basic Treatment Group. 6MWT will be conducted according to standard clinical protocols at baseline (before treatment initiation) and 6 months after treatment initiation to evaluate changes in functional exercise capacity (a key component of cardiopulmonary exercise tolerance).
Differences in estimated Glomerular Filtration Rate (eGFR) between the two groups before and after 6 months of treatment
时间窗: At baseline and 6 months after treatment initiation.
Compare the changes in eGFR (a key indicator of overall renal filtration function) between the Exercise Rehabilitation Group and Basic Treatment Group, to assess the intervention's effect on renal filtration function. Higher eGFR values indicate better renal filtration function. Measurement Details: eGFR (unit: mL/min/1.73m²), calculated via the CKD-EPI equation using serum creatinine values measured by standard clinical laboratory biochemical analysis (e.g., enzymatic method).
Difference in Serum Creatinine (Scr) between the two groups before and after 6 months of treatment
时间窗: At baseline and 6 months after treatment initiation.
Compare the changes in Scr (a marker of renal excretory function) between the Exercise Rehabilitation Group and Basic Treatment Group, to assess the intervention's effect on renal excretory function. Higher Scr values typically indicate impaired renal excretory function. Measurement Details: Scr (unit: μmol/L), measured via standard clinical laboratory biochemical analysis (e.g., picric acid method or enzymatic method).
Difference in Left Ventricular Ejection Fraction (LVEF) between the two groups before and after 6 months of treatment
时间窗: At baseline and 6 months after treatment initiation.
Compare the change in Left Ventricular Ejection Fraction (LVEF) between the Exercise Rehabilitation Group and the Basic Treatment Group.Measurement name: Left Ventricular Ejection Fraction (LVEF).Measurement tool: Transthoracic Echocardiography (TTE, standard clinical ultrasound examination).Unit of measure: Percentage (%).Outcome interpretation: Higher LVEF values indicate better left ventricular systolic function (normal range: 50%-70% in adults); changes in LVEF reflect the intervention's effect on cardiac contractile function.LVEF will be measured via TTE at baseline (before treatment initiation) and 6 months after treatment initiation.
次要结局
- Difference in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels between the two groups before and after 6 months of treatment(At baseline and 6 months after treatment initiation.)
- Difference in cystatin C (Cys-C) levels between the two groups before and after 6 months of treatment(At baseline and 6 months after treatment initiation.)
- Difference in high-sensitivity C-reactive protein (hs-CRP) levels between the two groups before and after 6 months of treatment(At baseline and 6 months after treatment initiation.)
- Differences in scores of the Minnesota Living with Heart Failure Questionnaire between the two groups before and after 6 months of treatment(At baseline and 6 months after treatment initiation.)
研究者
Haiyan Pan
Professor and Chief Physician, Department of Cardiology
Affiliated Hospital of Nantong University