NCT07521540

Brief Summary

Post-intensive care syndrome (PICS) is characterized by persistent physical, cognitive, and psychological impairments among survivors of critical illness. Although advances in intensive care medicine have reduced mortality, a large proportion of ICU survivors experience long-term functional impairments after discharge. High-dependency units (HDUs) serve as transitional care settings between intensive care units and general wards. Many critically ill survivors who cannot directly return home are transferred to HDU for continued treatment and rehabilitation. However, evidence regarding systematic multidisciplinary rehabilitation interventions in HDU settings remains limited. This prospective single-center interventional study aims to evaluate the effects of an integrated multidisciplinary rehabilitation model implemented in the HDU on physical, cognitive, and psychological outcomes among patients with post-intensive care syndrome. All enrolled patients will receive standardized integrated medical, nursing, and rehabilitation interventions. Multidimensional functional assessments will be conducted at baseline, during hospitalization, and before discharge from the HDU.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

March 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

March 12, 2026

Last Update Submit

April 8, 2026

Conditions

Keywords

Ventilator liberationHigh-dependency unitPost-ICU rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in Physical Function (CPAx Score)

    Change in Chelsea Critical Care Physical Assessment Tool (CPAx) score from baseline to HDU discharge. The CPAx score ranges from 0 to 50, with higher scores indicating better physical function.

    Baseline (within 48 hours after HDU admission) and at HDU discharge,assessed up to 2 days

Study Arms (1)

Integrated Multidisciplinary Rehabilitation in HDU

EXPERIMENTAL

Participants transferred from the intensive care unit (ICU) to the high-dependency unit (HDU) who meet the diagnostic criteria for post-intensive care syndrome (PICS) will receive an integrated multidisciplinary rehabilitation program during their HDU stay. The intervention includes coordinated medical management, respiratory rehabilitation, physical rehabilitation, rehabilitation nursing, and cognitive and psychological interventions delivered by a multidisciplinary team.

Behavioral: Integrated Multidisciplinary Rehabilitation

Interventions

Participants will receive a standardized multidisciplinary rehabilitation program implemented in the HDU, including: Medical management Continuous treatment of primary diseases, medication optimization, complication prevention, and gradual removal of medical devices. Respiratory rehabilitation Respiratory muscle training, airway clearance techniques, and breathing pattern training. Physical rehabilitation Progressive mobilization according to patient tolerance, including passive exercises, active bed exercises, sitting training, standing training, and walking training. Sessions are conducted 1-2 times per day, lasting 20-40 minutes each. Rehabilitation nursing Position management, pressure injury prevention, device safety management, and sleep management. Cognitive and psychological interventions Orientation training, cognitive stimulation activities, psychological support, and family participation.

Integrated Multidisciplinary Rehabilitation in HDU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Diagnosed with post-intensive care syndrome
  • Transferred from ICU to HDU
  • Available paired admission and discharge data

You may not qualify if:

  • Death within 24 hours after HDU admission
  • Missing primary outcome data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Rehabilitation Hospital Affiliated to Capital Medical University

Beijing, Shijingshan, 100144, China

Location

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

  • Hongying Jiang, MD

    Beijing Rehabilitation Hospital of Capital Medical University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

March 12, 2026

First Posted

April 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations