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

Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients: a Randomized Controlled Study (NutriPhyT Trial)

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Malnutrition; ICU Acquired Weakness
• Intervention / Treatment: Other: Optimisation of nutrition therapy coupled with early mobilisation; Other: Standard care

Detailed Description

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. Indeed, these patients are at high risk of complications related to their ICU stay (cognitive impairment, ICU acquired weakness, diaphragm dysfunction, ICU polyneuropathy, post-traumatic stress, malnutrition, etc.). Despite prolonged periods of rehabilitation, there is a significant decrease in functional status and quality of life compared to the previous status of these patient.

A specific management by a multidisciplinary team has been set up since 2017 at the Geneva-ICU for long-stay patients (hospitalised ≥ 7 days) including special attention to weaning from ventilation, nutrition, mobilisation, anxiety, pain, skin condition etc.

The culture of nutritional therapy and early mobilisation is already well established at the Geneva-ICU. However, a comprehensive approach to nutrition and mobilisation during and after the ICU stay could be optimised.

The objective of the study is to determine whether optimization of nutritional therapy combined with early mobilization for patients with long ICU stay will improve muscle function at discharge compared with patients receiving standard care.

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudia Heidegger, MD; Phone Number: + 41 22 37 27 440; Email: claudia.heidegger@hcuge.ch
• Study Contact Backup: Name: Aude de Watteville, Bsc; Phone Number: + 41 79 55 33 998; Email: aude.dewatteville@hcuge.ch

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • Service of Intensive Care, Geneva University Hospital,
    • Contact: Claudia Heidegger, MD; Email: claudia.heidegger@hcuge.ch
    • Contact: Aude De Watteville, Bsc; Email: aude.dewatteville@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: Standard care; Patients will receive nutritional therapy and mobilisation according to local standard procedures.
Experimental: Interventional group	Other: Optimisation of nutrition therapy coupled with early mobilisation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking distance	6 MWT	Hospital discharge or end of the intervention (4 weeks after ICU discharge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking distance	6 MWT	At ICU discharge (if achievable); 6 months post-ICU stay
Body composition	Electrical bio impedance	At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Body composition	Peripheral muscle ultrasound	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	Handgrip	At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Gradation of muscle function	MRC	At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Physical functionality	PFIT & SPPB	At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Weight difference	Comparison between weight at ICU admission, at hospital discharge and at 6 months post-ICU stay	At ICU admission, at ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Appetite	10-point survey scale	At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Food intake estimation	3 days food diary	At 6 months post-ICU stay
Quality of life (SF-12)	SF-12	At 6 months post-ICU stay
Return to work/activity preceding to the event	Collected during the 6 month post-ICU stay consultation	At 6 months post-ICU stay
Length of ICU and hospital stay	Collected in the patient form	At ICU and hospital discharge
Duration of mechanical ventilation	Collected in the patient form	At ICU discharge

Collaborators and Investigators

• Sponsor: HEIDEGGER CP
• Investigators: Principal Investigator: Claudia Heidegger, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Physiotherapy; Early mobilisation; Early nutrition therapy; Long stay ICU patient
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Disease Attributes; Malnutrition; Critical Illness
• Other Study ID Numbers: NutriPhyT2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No