Dietary Intervention and Physical Activity in Patients With Heart Failure and Reduced Ejection Fraction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorMedical University of Silesia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Resistance Exercise
BehavioralThe exercise intervention includes resistance training using elastic bands, with instruction and follow-up provided by a medical rehabilitation specialist.
Dietary Intervention
BehavioralIndividualized 14-day meal plan based on the DASH diet with high-protein components.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Standard medical careNo intervention 0 interventions
Group B: Resistance Exercise TrainingExperimental treatment 1 intervention
Group C: Dietary InterventionExperimental treatment 1 intervention
Group D: Combined Dietary and Exercise InterventionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in skeletal muscle mass
Quantitative assessment of skeletal muscle mass change over the study period.
Time frame
Baseline to 6 monthsSecondary outcomes
1
Change in quality of life
Assessed using the Minnesota Living With Heart Failure Questionnaire.
Time frame
Baseline to 6 months2
Change in exercise capacity
Assessed by the 6-minute walk test.
Time frame
Baseline to 6 months3
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').
Time frame
Baseline to 6 months4
Change in laboratory biomarkers
Includes NT-proBNP, HbA1c, K+ creatine, triglycerides, cholesterol,
Time frame
Baseline to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov