Dietary Intervention and Physical Activity in Patients With Heart Failure and Reduced Ejection Fraction
Heart failure with reduced ejection fraction (HFrEF) is frequently associated with abnormalities in body composition, including reduced skeletal muscle mass and sarcopenia, which are independent predictors of reduced exercise tolerance, impaired quality of life, and increased mortality. Despite advances in pharmacological therapy, evidence-based non-pharmacological strategies aimed at preventing muscle mass loss remain limited.
This randomized controlled trial aims to evaluate the effects of dietary intervention based on the DASH diet with high-protein elements, resistance exercise training, and their combination on skeletal muscle mass, functional capacity, echocardiographic parameters, biochemical markers, and quality of life in patients with HFrEF.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Silesian Voivodeship
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Zabrze、Silesian Voivodeship、波兰、41-800
- 招聘中
- 2nd Department and Clinical Ward of Cardiology Specialist Hospital in Zabrze, Poland
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接触：
- Andrzej Tomasik PhD Andrzej Tomasik
- 电话号码：+48 32 271 10 10
- 邮箱：atomasik@sum.edu.pl
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
Written informed consent obtained prior to participation Age >30 years Diagnosis of chronic heart failure, NYHA functional class I-III Left ventricular ejection fraction <40%
Exclusion Criteria:
NYHA functional class IV heart failure Potentially reversible cause of heart failure Estimated glomerular filtration rate <30 mL/min Severe anemia (hemoglobin <9 g/dL) Uncontrolled thyroid disease Severe hepatic dysfunction History of hyperkalemia or hyperkalemia at baseline Epilepsy Presence of joint endoprostheses Gastrointestinal disorders limiting adherence to the DASH diet Physical limitations precluding participation in structured exercis
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：标准医疗保健
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实验性的：Resistance Exercise Training
Elastic resistance bands and structured exercise education provided by a medical rehabilitation specialist.
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The exercise intervention includes resistance training using elastic bands, with instruction and follow-up provided by a medical rehabilitation specialist.
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实验性的：Dietary Intervention
Individualized 14-day meal plan based on the DASH diet with high-protein components.
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Individualized 14-day meal plan based on the DASH diet with high-protein components.
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实验性的：Combined Dietary and Exercise Intervention
Combination of dietary counseling and resistance exercise training as described above.
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The exercise intervention includes resistance training using elastic bands, with instruction and follow-up provided by a medical rehabilitation specialist.
Individualized 14-day meal plan based on the DASH diet with high-protein components.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in skeletal muscle mass
大体时间：Baseline to 6 months
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Quantitative assessment of skeletal muscle mass change over the study period.
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Baseline to 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in quality of life
大体时间：Baseline to 6 months
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Assessed using the Minnesota Living With Heart Failure Questionnaire.
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Baseline to 6 months
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Change in exercise capacity
大体时间：Baseline to 6 months
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Assessed by the 6-minute walk test.
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Baseline to 6 months
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Change in echocardiographic parameters of diastolic function
大体时间：Baseline to 6 months
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Changes in left ventricular diastolic function assessed by transthoracic echocardiography, including early transmitral inflow velocity (E), the ratio of early to late transmitral inflow velocities (E/A), and early diastolic mitral annular velocity (e').
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Baseline to 6 months
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Change in laboratory biomarkers
大体时间：Baseline to 6 months
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Includes NT-proBNP, HbA1c, K+ creatine, triglycerides, cholesterol,
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Baseline to 6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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