Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients (NutriPhyT Trial)

NCT05865314 | Recruiting

• 1 other identifier: NutriPhyT2022
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

Due to medical advances and quality of care, mortality in adult intensive care units (ICUs) has decreased significantly in recent years, leading to a significant increase in the number of patients with high rehabilitation needs on discharge from the ICU. A specific management by a multidisciplinary team has been set up since 2017 at the Geneva-ICU for long-stay patients (hospitalised ≥ 7 days). This study aim to assess whether an optimization of the nutritional therapy coupled with an early mobility during and after the ICU stay allows an improvement in the muscle function at hospital discharge compared to patients receiving the standard care.

Conditions

Critical Illness; ICU Acquired Weakness; Malnutrition

Keywords

Early nutrition therapy; Early mobilisation; Long stay ICU patient; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Walking distance

  6 MWT

  Hospital discharge or end of the intervention (4 weeks after ICU discharge)

Secondary Outcomes (13)

• Walking distance

  At ICU discharge (if achievable); 6 months post-ICU stay

• Body composition

  At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay

• Body composition

  Within the 1st 48 hours post ICU admission, at ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay

• Grip Strength

  At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay

• Gradation of muscle function

  At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay

Study Arms (2)

Interventional group

EXPERIMENTAL

Other: Optimisation of nutrition therapy coupled with early mobilisation

Control group

ACTIVE COMPARATOR

Other: Standard care

Interventions

Optimisation of nutrition therapy coupled with early mobilisation OTHER

Optimisation of nutrition therapy coupled with early mobilisation with: * Optimisation of nutrition therapy during ICU stay * Optimisation of physiotherapy during ICU stay * Better communication and closer collaboration between physiotherapy and nutrition teams. * Optimisation of continuity of the care.

Interventional group

Standard care OTHER

Patients will receive nutritional therapy and mobilisation according to local standard procedures.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient admitted to the adult ICU :
• ≥18 years old
• On mechanical ventilation with an expected length of stay ≥ 7 days
• Requiring artificial nutrition (enteral and/or parenteral nutrition)

You may not qualify if:

• Therapeutic withdrawal Pregnant or breastfeeding patients
• Neurological disorders with motor deficits:
• New or pre-existing neuromuscular or nervous system disease
• Spinal cord injury Severe polytrauma of the lower limbs (amputation etc.) Non-independent ambulation (including walking aids) before ICU admission
• For organizational reasons not allowing follow-up :
• Transfer to another ICU
• Patient living abroad from Switzerland
• Patient living in nursing homes preceding to ICU admission
• Incarcerated patients
• Intellectual/cognitive disabilities or language barrier, limiting ability to follow the instructions

Sponsors & Collaborators

• HEIDEGGER CP: lead

Study Sites (1)

Service of Intensive Care, Geneva University Hospital,

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Critical Illness; Malnutrition

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Claudia Heidegger, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Heidegger, MD

CONTACT

+ 41 22 37 27 440; claudia.heidegger@hcuge.ch

Aude de Watteville, Bsc

CONTACT

+ 41 79 55 33 998; aude.dewatteville@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy head physician, Head of the Intensive Care Polyvalent Unit, Division of Intensive Care

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: May 18, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

CH (1)