Critical IllnessNutriPhyTNCT05865314
Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients (NutriPhyT Trial)
A study testing Optimisation of nutrition therapy coupled with early mobilisation in people with Critical Illness and ICU Acquired Weakness, run by HEIDEGGER CP at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, ICU Acquired Weakness, Malnutrition
- What is being tested?
- Optimisation of nutrition therapy coupled with early mobilisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2023to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Service of Intensive Care, Geneva University Hospital,
Geneva, Canton of Geneva, 1211
Claudia Heidegger, MD, claudia.heidegger@hcuge.ch
Aude De Watteville, Bsc, aude.dewatteville@hcuge.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness, ICU Acquired Weakness, Malnutrition
- Being tested
- Optimisation of nutrition therapy coupled with early mobilisation, Standard care
- Keywords
- Early nutrition therapy, Early mobilisation, Long stay ICU patient, Physiotherapy
- Medical subject headings
- Critical Illness, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimisation of nutrition therapy coupled with early mobilisationOther
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.
Standard careOther
Patients will receive nutritional therapy and mobilisation according to local standard procedures.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Not described Receives: Other: Optimisation of nutrition therapy coupled with early mobilisation |
| Control group | Active comparator | Not described Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking distance
6 MWT
Measured: Hospital discharge or end of the intervention (4 weeks after ICU discharge)
Secondary outcomes (13)
Walking distance
6 MWT
Measured: At ICU discharge (if achievable); 6 months post-ICU stay
Body composition
Electrical bio impedance
Measured: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Body composition
Peripheral muscle ultrasound
Measured: 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
Measured: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Gradation of muscle function
MRC
Measured: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Physical functionality
PFIT \& SPPB
Measured: 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
Measured: 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
Measured: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Food intake estimation
3 days food diary
Measured: At 6 months post-ICU stay
Quality of life (SF-12)
SF-12
Measured: At 6 months post-ICU stay
Return to work/activity preceding to the event
Collected during the 6 month post-ICU stay consultation
Measured: At 6 months post-ICU stay
Length of ICU and hospital stay
Collected in the patient form
Measured: At ICU and hospital discharge
Duration of mechanical ventilation
Collected in the patient form
Measured: At ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 May 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HEIDEGGER CP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HEIDEGGER CP, University Hospital, Geneva
- Investigators
- Claudia Heidegger, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865314
- Sponsor's protocol ID
- NutriPhyT2022
- Acronym
- NutriPhyT
- Status last verified
- Aug 2025
- First submitted
- 23 Mar 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients: a Randomized Controlled Study (NutriPhyT Trial)
- ClinicalTrials.gov ID
- NCT05865314
- Acronym / sponsor ID
- NutriPhyT / NutriPhyT2022
- Conditions
- Critical Illness, ICU Acquired Weakness, Malnutrition
- Keywords
- Early nutrition therapy, Early mobilisation, Long stay ICU patient, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- HEIDEGGER CPUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Optimisation of nutrition therapy coupled with early mobilisation |
| Control group | Active comparator | Other: Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years old
- On mechanical ventilation with an expected length of stay ≥ 7 days
- Requiring artificial nutrition (enteral and/or parenteral nutrition)
Key exclusion criteria (10 listed)
- Therapeutic withdrawal Pregnant or breastfeeding patients
- 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
- Transfer to another ICU
- Patient living abroad from Switzerland
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimisation of nutrition therapy coupled with early mobilisationOptimisation 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. | Other | Interventional group |
| Standard carePatients will receive nutritional therapy and mobilisation according to local standard procedures. | Other | Control group |
Primary outcome
Walking distance
Time frame: Hospital discharge or end of the intervention (4 weeks after ICU discharge)
6 MWT
13 secondary outcomes
Walking distance
Time frame: At ICU discharge (if achievable); 6 months post-ICU stay
Body composition
Time frame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Body composition
Time frame: 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
Time frame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Gradation of muscle function
Time frame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Physical functionality
Time frame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Weight difference
Time frame: At ICU admission, at ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Appetite
Time frame: At ICU discharge; at hospital discharge or end of the intervention; at 6 months post-ICU stay
Food intake estimation
Time frame: At 6 months post-ICU stay
Quality of life (SF-12)
Time frame: At 6 months post-ICU stay
Return to work/activity preceding to the event
Time frame: At 6 months post-ICU stay
Length of ICU and hospital stay
Time frame: At ICU and hospital discharge
Duration of mechanical ventilation
Time frame: At ICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Heidegger, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimisation of nutrition therapy coupled with early mobilisation in people with Critical Illness and ICU Acquired Weakness, run by HEIDEGGER CP at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Heidegger, MD (+ 41 22 37 27 440, claudia.heidegger@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking distance (time frame: Hospital discharge or end of the intervention (4 weeks after ICU discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.