Post-Intensive Care Syndrome (PICS)NCT07521540
Integrated Rehabilitation in HDU for Post-Intensive Care SyndromeLiberation in Patients With PICS
A study testing Integrated Multidisciplinary Rehabilitation in people with Post-Intensive Care Syndrome (PICS) and Critical Illness Recovery, run by Hongying Jiang, MD at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Intensive Care Syndrome (PICS), Critical Illness Recovery, Mechanical Ventilation
- What is being tested?
- Integrated Multidisciplinary Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years
- Diagnosed with post-intensive care syndrome
- Transferred from ICU to HDU
- Available paired admission and discharge data
Who cannot join
- Death within 24 hours after HDU admission
- Missing primary outcome data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Rehabilitation Hospital Affiliated to Capital Medical University
Beijing, Shijingshan, 100144
About this study
Official title: 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.
Read the 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.
- Being tested
- Integrated Multidisciplinary Rehabilitation
- Keywords
- Ventilator liberation, High-dependency unit, Post-ICU rehabilitation
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Multidisciplinary RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Integrated Multidisciplinary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (within 48 hours after HDU admission) and at HDU discharge,assessed up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Intensive Care Syndrome (PICS)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongying Jiang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hongying Jiang, MD, Capital Medical University
- Investigators
- Hongying Jiang, MD, Study chair, Beijing Rehabilitation Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521540
- Sponsor's protocol ID
- 2026bkky-hxk-PICS
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Integrated Multidisciplinary Rehabilitation in a High-Dependency Unit on Outcomes of Patients With Post-Intensive Care Syndrome: A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT07521540
- Acronym / sponsor ID
- 2026bkky-hxk-PICS
- Keywords
- Ventilator liberation, High-dependency unit, Post-ICU rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hongying Jiang, MDUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Apr 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated Multidisciplinary Rehabilitation in HDU | Experimental | Behavioral: Integrated Multidisciplinary RehabilitationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Diagnosed with post-intensive care syndrome
- Transferred from ICU to HDU
- Available paired admission and discharge data
Key exclusion criteria (2 listed)
- Death within 24 hours after HDU admission
- Missing primary outcome data
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 |
|---|---|---|
| Integrated Multidisciplinary RehabilitationParticipants 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. | Behavioural | Integrated Multidisciplinary Rehabilitation in HDU |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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PICS-p Longitudinal Cohort Study
Physical Functional Impairment, Cognitive Impairment
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Post-ICU Syndrome and Social Determinants of Healths
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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.
Hongying Jiang, MD study chair
Beijing Rehabilitation Hospital of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Multidisciplinary Rehabilitation in people with Post-Intensive Care Syndrome (PICS) and Critical Illness Recovery, run by Hongying Jiang, MD at 1 site in China.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingyi Ge (+861056981098, ge_jingyi2020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Function (CPAx Score) (time frame: Baseline (within 48 hours after HDU admission) and at HDU discharge,assessed up to 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.