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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Silesian Voivodeship
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Zabrze, Silesian Voivodeship, Polen, 41-800
- Rekruttering
- 2nd Department and Clinical Ward of Cardiology Specialist Hospital in Zabrze, Poland
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Ta kontakt med:
- Andrzej Tomasik PhD Andrzej Tomasik
- Telefonnummer: +48 32 271 10 10
- E-post: atomasik@sum.edu.pl
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Standard medisinsk behandling
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in skeletal muscle mass
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in quality of life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Motorisk aktivitet
- Bevegelse
- Muskel- og skjelettfysiologiske fenomener
- Muskel- og skjelett og nevrale fysiologiske fenomener
- Terapeutikk
- Fysioterapi -modaliteter
- Pasientbehandling
- Treningsterapi
- Rehabilitering
- Ettervern
- Kontinuitet i pasientbehandling
- Ernæringsterapi
- Fysisk kondisjonering, menneskelig
- Øvelse
- Motstandstrening
- Kostholdsterapi
Andre studie-ID-numre
- BNW/NWN/0052/KB1/29/I/23/25
Legemiddel- og utstyrsinformasjon, studiedokumenter
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