Critical IllnessPHOENIXNCT06159868
Physiotherapy and Optimised Nutrition in Survivors of Critical Illness
A study testing Structured physiotherapy and rehabilitation in people with Critical Illness, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites in United Kingdom.
Trial summary
The goal of this randomised controlled feasibility study is to assess the feasibility and acceptability of individualised physiotherapy and optimised nutrition, delivered on the ward following discharge from intensive care to increase days alive and out of hospital, as well as the proposed methodology to optimise… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Structured physiotherapy and rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 May 2024to 8 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults (≥ 18 years) that received ≥ 4 days advanced respiratory support (defined as invasive or non-invasive ventilation) on ICU,
- Alive at ICU discharge
- On-going physiotherapy and dietetic rehabilitation needs identified by the PICUPS tool (Defined as patients who are unable to transfer from bed to chair independently AND not able to meet nutritional requirements independently).
Who cannot join
- Death expected within the next 72 hours,
- Poor pre-ICU admission mobility (inability to walk > 10 metres with or without an aid)
- mobilisation contraindicated (e.g., spinal injury),
- Contraindication to or inability to tolerate enteral nutrition,
- Significant brain injury and not recovered to a GCS of ≥ 14 by ICU discharge.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospitals Coventry & Warwickshire
Coventry, Midlands, CV2 2DX
Oxford University Hospitals Foundation Trust
Oxford
About this study
Official title: Physiotherapy and Optimised Enteral Nutrition In the Post-acute Phase of Critical Illness (PHOENIX): A Randomised Controlled Feasibility Trial
The goal of this randomised controlled feasibility study is to assess the feasibility and acceptability of individualised physiotherapy and optimised nutrition, delivered on the ward following discharge from intensive care to increase days alive and out of hospital, as well as the proposed methodology to optimise design and delivery for a definitive evaluation trial. Specific objectives are:
- To assess acceptability of the intervention to users and providers. ii. To assess feasibility of recruitment procedures for a future trial. iii. To estimate recruitment, retention and measure completion rates for a future trial.
Participants will receive a combination of structured, individualised physiotherapy and optimised nutrition, beginning immediately following recruitment and continuing for up to 14days or hospital discharge, whichever is sooner. As a feasibility trial the primary outcomes to be assessed are around study feasibility. The investigators will also compare clinical outcomes for the intervention participants in comparison to those receiving standard care to see if the intervention increases the number of days alive and out of hospital within 30 days of recruitment.
Read the detailed description
Research question Is it feasible and acceptable to undertake a randomised controlled trial evaluating the clinical and cost-effectiveness of an individualised physiotherapy and nutrition support intervention, delivered on the ward following ICU discharge, in adult survivors of critical illness?
Background Each year in the UK, 140,000 patients are discharged from intensive care units (ICU) to general hospital wards, almost all with complex rehabilitation needs. Eighty-four percent of patients still require nutritional support and 98% are not physically independent. Despite this, many are discharged from ICU without a nutrition plan and failure to recognise malnutrition is common. Consequently, malnutrition persists in the ward environment, leading to poor outcomes in itself, and additionally acts as a barrier to successful physical rehabilitation. This transition from intensive care to the ward represents a key stage in the recovery journey, and a window for optimising physical independence prior to hospital discharge, decreasing the need for support in the community. However, uncertainty as to how best to provide ongoing rehabilitation combining adequate nutrition and exercise on the general ward has driven widespread variation in practice.
The investigators have previously shown the benefits of delivering a structured rehabilitation strategy in the ICU. However, the ward environment poses different challenges to the development of an integrated rehabilitation pathway. There is a need to evaluate the clinical and cost-effectiveness of structured rehabilitation strategies when delivered outside the ICU.
Aims To evaluate the feasibility and acceptability of conducting a randomised controlled trial evaluating the clinical and cost-effectiveness of structured, individualised physiotherapy and nutritional support in ward-based patients following ICU discharge.
Objectives:
- To assess acceptability of the intervention to users and providers ii. To assess feasibility of recruitment procedures for a future trial iii. To estimate recruitment, retention and measure completion rates
Methods PHOENIX is a two-centre, allocation-concealed, open-label, parallel group, randomised controlled feasibility trial with integrated qualitative evaluation of acceptability.
The investigators will recruit sixty adult survivors from intensive care units at two university hospitals, with ongoing physiotherapy and nutritional needs at ICU discharge. Participants will be randomised on a 1:1 basis to receive the structured rehabilitation intervention or standard care. The intervention comprises enhanced physiotherapy, delivered by a specialist critical care team, in combination with optimised nutrition guided by indirect calorimetry.
Primary feasibility outcomes are recruitment and retention rates, and intervention fidelity. Acceptability will be evaluated through semi structured interviews of participants and staff.
- Conditions
- Critical Illness
- Being tested
- Structured physiotherapy and rehabilitation, Standard care
- Keywords
- physiotherapy, nutrition, rehabilitation, intensive care, exercise
- Medical subject headings
- Critical Illness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured physiotherapy and rehabilitationOther
Comprehensive baseline assessment of function and nutrition using indirect calorimetry to identify nutritional requirements, to create and individualised plan for followed by daily targeted mobility retraining, exercise and nutrition.
Standard careOther
Standard ward based care provided by usual care teams
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Structured and individualised physiotherapy in combination with optimised nutrition delivered by s specialist critical care rehabilitation team Receives: Other: Structured physiotherapy and rehabilitation |
| Control | Active comparator | Standard ward based care Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Proportion of patients agreeing to take part out of all those invited (recruitment rate)
Measured: At recruitment within the 6 month screening window
Retention rate
Proportion of participants who complete the primary outcome (retention rate)
Measured: from recruitment up to 30 days
Intervention adherence
Percentage of intervention sessions completed
Measured: For 14 days following recruitment
Secondary outcomes (4)
Days alive and out of hospital in 30 days
To evaluate the number of days alive and out of hospital within the 30 days following recruitment
Measured: 30 days following recruitment
Physical Function
Assessed using the 30 second sit to stand test
Measured: At baseline, 14 days and 30 days
Functional independence
Assessed using the Barthel Index
Measured: At baseline, 14 days and 30 days
Health Related Quality of Life
Assessed using the EQ5D-5L
Measured: At 30 days following recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 May 2024
- Primary completion8 Feb 2025
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- A mixed-methods, multicentre, randomised controlled feasibility study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159868
- Sponsor's protocol ID
- DM633323
- Acronym
- PHOENIX
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
King E, Wyer N, Barghouthy D, Reynolds E, Richardson H, Negus-Fancey M, Gallie L, Puthucheary Z, Gustafson O, McWilliams D. Patient and clinician acceptability of an integrated physiotherapy and nutrition intervention after ICU discharge: a qualitative exploration of a pre-specified co-primary feasibility outcome of the PHOENIX trial. EClinicalMedicine. 2026 Jul 20;98:104085. doi: 10.1016/j.eclinm.2026.104085. eCollection 2026 Aug.
PubMed 42495105McWilliams D, Gustafson O, Wyer N, Couper K, Kimani PK, Kandiyali R, El-Banna A, Barghouthy D, Haylett R, King E, Richardson H, Negus-Fancey M, Gallie L, Matthews V, Puthucheary Z. Physiotherapy and optimised enteral nutrition in the post-acute phase of critical illness (PHOENIX): a randomised controlled feasibility trial. EClinicalMedicine. 2026 Jun 11;96:104000. doi: 10.1016/j.eclinm.2026.104000. eCollection 2026 Jun.
PubMed 42326381McWilliams D, Gustafson O, Wyer N, Couper K, Kimani P, Kandiyali R, Barghouthy D, Haylett R, Richardson H, Negus-Fancey M, King E, Gallie L, Puthucheary Z. Physiotherapy and Optimised Enteral Nutrition In the post-acute phase of critical illness (PHOENIX): protocol for a mixed methods feasibility randomised controlled trial. BMJ Open. 2025 Mar 27;15(3):e100803. doi: 10.1136/bmjopen-2025-100803.
PubMed 40147993
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy and Optimised Enteral Nutrition In the Post-acute Phase of Critical Illness (PHOENIX): A Randomised Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT06159868
- Acronym / sponsor ID
- PHOENIX / DM633323
- Conditions
- Critical Illness
- Keywords
- physiotherapy, nutrition, rehabilitation, intensive care, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- 1 May 2024 (actual)
- Primary completion
- 8 Feb 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 7 Dec 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.
The goal of this randomised controlled feasibility study is to assess the feasibility and acceptability of individualised physiotherapy and optimised nutrition, delivered on the ward following discharge from intensive care to increase days alive and out of hospital, as well as the proposed methodology to optimise design and delivery for a definitive evaluation trial. Specific objectives are:
- To assess acceptability of the intervention to users and providers. ii. To assess feasibility of recruitment procedures for a future trial. iii. To estimate recruitment, retention and measure completion rates for a future trial.
Participants will receive a combination of structured, individualised physiotherapy and optimised nutrition, beginning immediately following recruitment and continuing for up to 14days or hospital discharge, whichever is sooner. As a feasibility trial the primary outcomes to be assessed are around study feasibility. The investigators will also compare clinical outcomes for the intervention participants in comparison to those receiving standard care to see if the intervention increases the number of days alive and out of hospital within 30 days of recruitment.
Detailed description
Research question Is it feasible and acceptable to undertake a randomised controlled trial evaluating the clinical and cost-effectiveness of an individualised physiotherapy and nutrition support intervention, delivered on the ward following ICU discharge, in adult survivors of critical illness?
Background Each year in the UK, 140,000 patients are discharged from intensive care units (ICU) to general hospital wards, almost all with complex rehabilitation needs. Eighty-four percent of patients still require nutritional support and 98% are not physically independent. Despite this, many are discharged from ICU without a nutrition plan and failure to recognise malnutrition is common. Consequently, malnutrition persists in the ward environment, leading to poor outcomes in itself, and additionally acts as a barrier to successful physical rehabilitation. This transition from intensive care to the ward represents a key stage in the recovery journey, and a window for optimising physical independence prior to hospital discharge, decreasing the need for support in the community. However, uncertainty as to how best to provide ongoing rehabilitation combining adequate nutrition and exercise on the general ward has driven widespread variation in practice.
The investigators have previously shown the benefits of delivering a structured rehabilitation strategy in the ICU. However, the ward environment poses different challenges to the development of an integrated rehabilitation pathway. There is a need to evaluate the clinical and cost-effectiveness of structured rehabilitation strategies when delivered outside the ICU.
Aims To evaluate the feasibility and acceptability of conducting a randomised controlled trial evaluating the clinical and cost-effectiveness of structured, individualised physiotherapy and nutritional support in ward-based patients following ICU discharge.
Objectives:
- To assess acceptability of the intervention to users and providers ii. To assess feasibility of recruitment procedures for a future trial iii. To estimate recruitment, retention and measure completion rates
Methods PHOENIX is a two-centre, allocation-concealed, open-label, parallel group, randomised controlled feasibility trial with integrated qualitative evaluation of acceptability.
The investigators will recruit sixty adult survivors from intensive care units at two university hospitals, with ongoing physiotherapy and nutritional needs at ICU discharge. Participants will be randomised on a 1:1 basis to receive the structured rehabilitation intervention or standard care. The intervention comprises enhanced physiotherapy, delivered by a specialist critical care team, in combination with optimised nutrition guided by indirect calorimetry.
Primary feasibility outcomes are recruitment and retention rates, and intervention fidelity. Acceptability will be evaluated through semi structured interviews of participants and staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A mixed-methods, multicentre, randomised controlled feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Structured physiotherapy and rehabilitationStructured and individualised physiotherapy in combination with optimised nutrition delivered by s specialist critical care rehabilitation team |
| Control | Active comparator | Other: Standard careStandard ward based care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥ 18 years) that received ≥ 4 days advanced respiratory support (defined as invasive or non-invasive ventilation) on ICU,
- Alive at ICU discharge
- On-going physiotherapy and dietetic rehabilitation needs identified by the PICUPS tool (Defined as patients who are unable to transfer from bed to chair independently AND not able to meet nutritional requirements independently).
Key exclusion criteria (5 listed)
- Death expected within the next 72 hours,
- Poor pre-ICU admission mobility (inability to walk > 10 metres with or without an aid)
- mobilisation contraindicated (e.g., spinal injury),
- Contraindication to or inability to tolerate enteral nutrition,
- Significant brain injury and not recovered to a GCS of ≥ 14 by ICU discharge.
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 |
|---|---|---|
| Structured physiotherapy and rehabilitationComprehensive baseline assessment of function and nutrition using indirect calorimetry to identify nutritional requirements, to create and individualised plan for followed by daily targeted mobility retraining, exercise and nutrition. | Other | Intervention |
| Standard careStandard ward based care provided by usual care teams | Other | Control |
Primary outcome
Recruitment rate
Time frame: At recruitment within the 6 month screening window
Proportion of patients agreeing to take part out of all those invited (recruitment rate)
Retention rate
Time frame: from recruitment up to 30 days
Proportion of participants who complete the primary outcome (retention rate)
Intervention adherence
Time frame: For 14 days following recruitment
Percentage of intervention sessions completed
4 secondary outcomes
Days alive and out of hospital in 30 days
Time frame: 30 days following recruitment
Physical Function
Time frame: At baseline, 14 days and 30 days
Functional independence
Time frame: At baseline, 14 days and 30 days
Health Related Quality of Life
Time frame: At 30 days following recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Derived from this study: PubMed 42495105King E, Wyer N, Barghouthy D, Reynolds E, Richardson H, Negus-Fancey M, Gallie L, Puthucheary Z, Gustafson O, McWilliams D. Patient and clinician acceptability of an integrated physiotherapy and nutrition intervention after ICU discharge: a qualitative exploration of a pre-specified co-primary feasibility outcome of the PHOENIX trial. EClinicalMedicine. 2026 Jul 20;98:104085. doi: 10.1016/j.eclinm.2026.104085. eCollection 2026 Aug.
- Derived from this study: PubMed 42326381McWilliams D, Gustafson O, Wyer N, Couper K, Kimani PK, Kandiyali R, El-Banna A, Barghouthy D, Haylett R, King E, Richardson H, Negus-Fancey M, Gallie L, Matthews V, Puthucheary Z. Physiotherapy and optimised enteral nutrition in the post-acute phase of critical illness (PHOENIX): a randomised controlled feasibility trial. EClinicalMedicine. 2026 Jun 11;96:104000. doi: 10.1016/j.eclinm.2026.104000. eCollection 2026 Jun.
- Derived from this study: PubMed 40147993McWilliams D, Gustafson O, Wyer N, Couper K, Kimani P, Kandiyali R, Barghouthy D, Haylett R, Richardson H, Negus-Fancey M, King E, Gallie L, Puthucheary Z. Physiotherapy and Optimised Enteral Nutrition In the post-acute phase of critical illness (PHOENIX): protocol for a mixed methods feasibility randomised controlled trial. BMJ Open. 2025 Mar 27;15(3):e100803. doi: 10.1136/bmjopen-2025-100803.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured physiotherapy and rehabilitation in people with Critical Illness, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites in United Kingdom.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: At recruitment within the 6 month screening window). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06159868, which also lists 3 linked publications.
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 25 Nov 2025.