Dietary Intervention and Physical Activity in Patients With Heart Failure and Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in skeletal muscle mass
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
研究组 & 干预措施
Standard medical care
Resistance Exercise Training
Elastic resistance bands and structured exercise education provided by a medical rehabilitation specialist.
干预措施: Resistance Exercise (Behavioral)
Dietary Intervention
Individualized 14-day meal plan based on the DASH diet with high-protein components.
干预措施: Dietary Intervention (Behavioral)
Combined Dietary and Exercise Intervention
Combination of dietary counseling and resistance exercise training as described above.
干预措施: Resistance Exercise (Behavioral)
Combined Dietary and Exercise Intervention
Combination of dietary counseling and resistance exercise training as described above.
干预措施: Dietary Intervention (Behavioral)
结局指标
主要结局
Change in skeletal muscle mass
时间窗: Baseline to 6 months
Quantitative assessment of skeletal muscle mass change over the study period.
次要结局
- Change in quality of life(Baseline to 6 months)
- Change in exercise capacity(Baseline to 6 months)
- Change in echocardiographic parameters of diastolic function(Baseline to 6 months)
- Change in laboratory biomarkers(Baseline to 6 months)
研究者
Andrzej Tomasik MD PhD FESC
Associate Professor
Medical University of Silesia