Combined Rehabilitation and Nutritional Support vs. Standard Care in In-Hospital Endocarditis Treatment

NCT06563609 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-15

No results posted yet for this study

Summary

Infective endocarditis (IE) is associated with high morbidity and mortality. Patients with IE are affected by a lengthy hospitalization, leading to physical deconditioning and a rapid decline in physical fitness, muscle mass and strength. Moreover, prolonged antibiotic regimens frequently result in nausea, antibiotic-associated diarrhea and Clostridioides difficile (C.difficile) intestinal infections that further negatively affect patient health. These physical challenges are further exacerbated by the negative impact on mental health, increasing the overall burden of the illness. Implementing a targeted rehabilitative strategy in the hospital setting may therefore improve patient care including physical health and overall quality of life during hospitalization.

Conditions

  • Infective Endocarditis
  • Endocarditis, Bacterial
  • Infection; Heart
  • Bacteremia
  • Cardiac Rehabilitation
  • Nutrition Intervention
  • Physical Therapy
  • Probiotic Intervention

Interventions

BEHAVIORAL

Intensive physical Therapy

Tailored exercise programs supervised by trained physiotherapists, focusing on improving cardiorespiratory fitness, strength, and functional capacity.

DIETARY_SUPPLEMENT

Probiotic treatment

Administration of probiotic yeast Saccharomyces boulardii twice daily

BEHAVIORAL

Individualised Nutritional Support

Personalized nutritional plans guided by a dietitian, addressing malnutrition and caloric/protein deficiencies with daily caloric intake adjustments and supplements if necessary based on the EFFORT trial.

OTHER

Standard hospital care

Patients will receive standard hospital care

Sponsors & Collaborators

  • Johannes Grand

    lead OTHER

Principal Investigators

  • Johannes Grand, MD, PhD · Copenhagen University Hospital Amager-Hvidovre, Department of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-19
Primary Completion
2025-12-07
Completion
2025-12-07

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06563609 on ClinicalTrials.gov