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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Silesian Voivodeship
-
Zabrze, Silesian Voivodeship, Polen, 41-800
- Rekrytering
- 2nd Department and Clinical Ward of Cardiology Specialist Hospital in Zabrze, Poland
-
Kontakt:
- Andrzej Tomasik PhD Andrzej Tomasik
- Telefonnummer: +48 32 271 10 10
- E-post: atomasik@sum.edu.pl
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Medicinsk vård
|
|
|
Experimentell: Resistance Exercise Training
Elastic resistance bands and structured exercise education provided by a medical rehabilitation specialist.
|
The exercise intervention includes resistance training using elastic bands, with instruction and follow-up provided by a medical rehabilitation specialist.
|
|
Experimentell: Dietary Intervention
Individualized 14-day meal plan based on the DASH diet with high-protein components.
|
Individualized 14-day meal plan based on the DASH diet with high-protein components.
|
|
Experimentell: Combined Dietary and Exercise Intervention
Combination of dietary counseling and resistance exercise training as described above.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in skeletal muscle mass
Tidsram: Baseline to 6 months
|
Quantitative assessment of skeletal muscle mass change over the study period.
|
Baseline to 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in quality of life
Tidsram: Baseline to 6 months
|
Assessed using the Minnesota Living With Heart Failure Questionnaire.
|
Baseline to 6 months
|
|
Change in exercise capacity
Tidsram: Baseline to 6 months
|
Assessed by the 6-minute walk test.
|
Baseline to 6 months
|
|
Change in echocardiographic parameters of diastolic function
Tidsram: Baseline to 6 months
|
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
Tidsram: Baseline to 6 months
|
Includes NT-proBNP, HbA1c, K+ creatine, triglycerides, cholesterol,
|
Baseline to 6 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Motorisk aktivitet
- Rörelse
- Muskuloskeletala fysiologiska fenomen
- Muskuloskeletala och neurala fysiologiska fenomen
- Terapeutik
- Fysioterapimetoder
- Patientvård
- Träningsterapi
- Rehabilitering
- Eftervård
- Kontinuitet i patientvård
- Näringsterapi
- Fysisk konditionering, mänsklig
- Utöva
- Motståndsträning
- Dieterapi
Andra studie-ID-nummer
- BNW/NWN/0052/KB1/29/I/23/25
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .