- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07521540
Integrated Rehabilitation in HDU for Post-Intensive Care SyndromeLiberation in Patients With PICS
Effect of Integrated Multidisciplinary Rehabilitation in a High-Dependency Unit on Outcomes of Patients With Post-Intensive Care Syndrome: A Prospective Interventional Study
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Post-intensive care syndrome (PICS) includes physical weakness, cognitive impairment, and psychological disorders that occur after critical illness. Previous studies have shown that 50-70% of ICU survivors develop at least one PICS-related impairment within 6-12 months after discharge.
Current interventions mainly focus on ICU-based strategies such as the ABCDEF bundle, which can improve short-term outcomes but may not adequately address long-term functional recovery. Many patients remain severely debilitated after ICU discharge and require transitional care.
The high-dependency unit (HDU) represents a potential critical window for early rehabilitation intervention. Patients in this stage often have multiple functional impairments but remain medically stable enough to participate in rehabilitation programs.
This study will enroll patients transferred from ICU to HDU who meet diagnostic criteria for PICS. Participants will receive an integrated multidisciplinary intervention including medical management, respiratory rehabilitation, physical rehabilitation, nursing care, and cognitive-psychological support.
Functional assessments will be conducted at baseline, every two weeks during hospitalization, and prior to HDU discharge. The study will evaluate changes in physical, cognitive, and psychological outcomes associated with this intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jingyi Ge
- Phone Number: +861056981098
- Email: ge_jingyi2020@163.com
Study Locations
-
-
Shijingshan
-
Beijing, Shijingshan, China, 100144
- Beijing Rehabilitation Hospital Affiliated to Capital Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 years
- Diagnosed with post-intensive care syndrome
- Transferred from ICU to HDU
- Available paired admission and discharge data
Exclusion Criteria:
- Death within 24 hours after HDU admission
- Missing primary outcome data
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Integrated Multidisciplinary Rehabilitation in HDU
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Physical Function (CPAx Score)
Time Frame: Baseline (within 48 hours after HDU admission) and at HDU discharge,assessed up to 2 days
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Hongying Jiang, MD, Beijing Rehabilitation Hospital of Capital Medical University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026bkky-hxk-PICS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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