Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-28 @ 11:28 PM
Study NCT ID:
NCT06159868
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2023-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiotherapy and Optimised Nutrition in Survivors of Critical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Study outcome assessors will be blinded to group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A mixed-methods, multicentre, randomised controlled feasibility study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-11-28', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': 'At recruitment within the 6 month screening window', 'description': 'Proportion of patients agreeing to take part out of all those invited (recruitment rate)'}, {'measure': 'Retention rate', 'timeFrame': 'from recruitment up to 30 days', 'description': 'Proportion of participants who complete the primary outcome (retention rate)'}, {'measure': 'Intervention adherence', 'timeFrame': 'For 14 days following recruitment', 'description': 'Percentage of intervention sessions completed'}], 'secondaryOutcomes': [{'measure': 'Days alive and out of hospital in 30 days', 'timeFrame': '30 days following recruitment', 'description': 'To evaluate the number of days alive and out of hospital within the 30 days following recruitment'}, {'measure': 'Physical Function', 'timeFrame': 'At baseline, 14 days and 30 days', 'description': 'Assessed using the 30 second sit to stand test'}, {'measure': 'Functional independence', 'timeFrame': 'At baseline, 14 days and 30 days', 'description': 'Assessed using the Barthel Index'}, {'measure': 'Health Related Quality of Life', 'timeFrame': 'At 30 days following recruitment', 'description': 'Assessed using the EQ5D-5L'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physiotherapy', 'nutrition', 'rehabilitation', 'intensive care', 'exercise'], 'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '40147993', 'type': 'DERIVED', 'citation': 'McWilliams 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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\ni. 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.\n\nParticipants 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.', 'detailedDescription': '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?\n\nBackground 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.\n\nThe 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.\n\nAims 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.\n\nObjectives:\n\ni. 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\n\nMethods PHOENIX is a two-centre, allocation-concealed, open-label, parallel group, randomised controlled feasibility trial with integrated qualitative evaluation of acceptability.\n\nThe 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.\n\nPrimary feasibility outcomes are recruitment and retention rates, and intervention fidelity. Acceptability will be evaluated through semi structured interviews of participants and staff.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥ 18 years) that received ≥ 4 days advanced respiratory support (defined as invasive or non-invasive ventilation) on ICU,\n* Alive at ICU discharge\n* 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).\n\nExclusion Criteria:\n\n* Death expected within the next 72 hours,\n* Poor pre-ICU admission mobility (inability to walk \\> 10 metres with or without an aid)\n* mobilisation contraindicated (e.g., spinal injury),\n* Contraindication to or inability to tolerate enteral nutrition,\n* Significant brain injury and not recovered to a GCS of ≥ 14 by ICU discharge.'}, 'identificationModule': {'nctId': 'NCT06159868', 'acronym': 'PHOENIX', 'briefTitle': 'Physiotherapy and Optimised Nutrition in Survivors of Critical Illness', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Coventry and Warwickshire NHS Trust'}, 'officialTitle': 'Physiotherapy and Optimised Enteral Nutrition In the Post-acute Phase of Critical Illness (PHOENIX): A Randomised Controlled Feasibility Trial', 'orgStudyIdInfo': {'id': 'DM633323'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Structured and individualised physiotherapy in combination with optimised nutrition delivered by s specialist critical care rehabilitation team', 'interventionNames': ['Other: Structured physiotherapy and rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Standard ward based care', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'Structured physiotherapy and rehabilitation', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Intervention']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Standard ward based care provided by usual care teams', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CV2 2DX', 'city': 'Coventry', 'state': 'Midlands', 'country': 'United Kingdom', 'facility': 'University Hospitals Coventry & Warwickshire', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Coventry and Warwickshire NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}