Physiotherapy and Optimised Nutrition in Survivors of Critical Illness

NCT06159868 | Completed DMC

• 1 other identifier: DM633323
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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 design and delivery for a definitive evaluation trial. Specific objectives are: i. 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.

Conditions

Critical Illness

Keywords

physiotherapy; nutrition; rehabilitation; intensive care; exercise

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Proportion of patients agreeing to take part out of all those invited (recruitment rate)

  At recruitment within the 6 month screening window

• Retention rate

  Proportion of participants who complete the primary outcome (retention rate)

  from recruitment up to 30 days

• Intervention adherence

  Percentage of intervention sessions completed

  For 14 days following recruitment

Secondary Outcomes (4)

• Days alive and out of hospital in 30 days

  30 days following recruitment

• Physical Function

  At baseline, 14 days and 30 days

• Functional independence

  At baseline, 14 days and 30 days

• Health Related Quality of Life

  At 30 days following recruitment

Study Arms (2)

Intervention

EXPERIMENTAL

Structured and individualised physiotherapy in combination with optimised nutrition delivered by s specialist critical care rehabilitation team

Other: Structured physiotherapy and rehabilitation

Control

ACTIVE COMPARATOR

Standard ward based care

Other: Standard care

Interventions

Structured physiotherapy and rehabilitation OTHER

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.

Intervention

Standard care OTHER

Standard ward based care provided by usual care teams

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (2)

University Hospitals Coventry & Warwickshire

Coventry, Midlands, CV2 2DX, United Kingdom

Location

Oxford University Hospitals Foundation Trust

Oxford, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40147993 DERIVED

MeSH Terms

Conditions

Critical Illness; Motor Activity

Interventions

Rehabilitation; Standard of Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study outcome assessors will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A mixed-methods, multicentre, randomised controlled feasibility study.

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 7, 2023
• Study Start: May 1, 2024
• Primary Completion: February 8, 2025
• Study Completion: April 8, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)