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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05865314
Acronym
NutriPhyT
Enrollment
164
Registered
2023-05-18
Start date
2023-05-01
Completion date
2026-09-01
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, ICU Acquired Weakness, Malnutrition

Keywords

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

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.

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.

Interventions

OTHEROptimisation 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.

OTHERStandard care

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

Sponsors

HEIDEGGER CP
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Walking distanceHospital discharge or end of the intervention (4 weeks after ICU discharge)6 MWT

Secondary

MeasureTime frameDescription
Body compositionAt ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stayElectrical bio impedance
Grip StrengthAt ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stayHandgrip
Gradation of muscle functionAt ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stayMRC
Physical functionalityAt ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stayPFIT & SPPB
Weight differenceAt ICU admission, at ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stayComparison between weight at ICU admission, at hospital discharge and at 6 months post-ICU stay
Walking distanceAt ICU discharge (if achievable); 6 months post-ICU stay6 MWT
Food intake estimationAt 6 months post-ICU stay3 days food diary
Quality of life (SF-12)At 6 months post-ICU staySF-12
Return to work/activity preceding to the eventAt 6 months post-ICU stayCollected during the 6 month post-ICU stay consultation
Length of ICU and hospital stayAt ICU and hospital dischargeCollected in the patient form
Duration of mechanical ventilationAt ICU dischargeCollected in the patient form
AppetiteAt ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay10-point survey scale

Countries

Switzerland

Contacts

Primary ContactClaudia Heidegger, MD
claudia.heidegger@hcuge.ch+ 41 22 37 27 440
Backup ContactAude de Watteville, Bsc
aude.dewatteville@hcuge.ch+ 41 79 55 33 998

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026