Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard medical care | No Intervention | ||
| Resistance Exercise Training | Experimental | Elastic resistance bands and structured exercise education provided by a medical rehabilitation specialist. |
|
| Dietary Intervention | Experimental | Individualized 14-day meal plan based on the DASH diet with high-protein components. |
|
| Combined Dietary and Exercise Intervention | Experimental | Combination of dietary counseling and resistance exercise training as described above. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance Exercise | Behavioral | The exercise intervention includes resistance training using elastic bands, with instruction and follow-up provided by a medical rehabilitation specialist. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skeletal muscle mass | Quantitative assessment of skeletal muscle mass change over the study period. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | Assessed using the Minnesota Living With Heart Failure Questionnaire. | Baseline to 6 months |
| Change in exercise capacity | Assessed by the 6-minute walk test. |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Department and Clinical Ward of Cardiology Specialist Hospital in Zabrze, Poland | Recruiting | Zabrze | Silesian Voivodeship | 41-800 | Poland |
Not provided
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dietary Intervention | Behavioral | Individualized 14-day meal plan based on the DASH diet with high-protein components. |
|
| Baseline to 6 months |
| Change in echocardiographic parameters of diastolic function | 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'). | Baseline to 6 months |
| Change in laboratory biomarkers | Includes NT-proBNP, HbA1c, K+ creatine, triglycerides, cholesterol, | Baseline to 6 months |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D044623 | Nutrition Therapy |