Severe Acute Pancreatitis PatientsNCT07109921
Early Rehabilitation for Severe Acute Pancreatitis (ERN-SAP)
A study testing Structured Early Rehabilitation Nursing Program in people with Severe Acute Pancreatitis Patients, run by Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University at 1 site in China.
Trial summary
This prospective, randomized controlled trial investigates the efficacy of a structured early rehabilitation nursing (ERN) program compared to usual care in patients with severe acute pancreatitis (SAP). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Severe Acute Pancreatitis Patients
- What is being tested?
- Structured Early Rehabilitation Nursing Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years.
- A diagnosis of SAP according to the 2012 revised Atlanta classification.
- Admission to the ICU within 72 hours of symptom onset.
- An anticipated ICU stay of more than 48 hours.
Who cannot join
- Pre-existing conditions precluding rehabilitation (e.g., severe neuromuscular disease, unstable spinal fractures).
- Acute myocardial infarction or unstable cardiac arrhythmia.
- Intracranial hypertension.
- Active gastrointestinal bleeding.
- Pregnancy.
- Patient or family refusal.
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
Wuhan, Hubei, 430000
About this study
Official title: Effect of a Structured Early Rehabilitation Program on Long-Term Functional Recovery, Quality of Life, and Survival in Patients With Severe Acute Pancreatitis: A 5-Year Randomized Controlled Trial
This prospective, randomized controlled trial investigates the efficacy of a structured early rehabilitation nursing (ERN) program compared to usual care in patients with severe acute pancreatitis (SAP). Four hundred patients admitted to the intensive care unit (ICU) were randomized to either receive the ERN intervention or usual care. The study aims to evaluate the effects of ERN on ICU and hospital length of stay, systemic inflammation, physical function, long-term quality of life, and one-year survival.
Read the detailed description
Patients with severe acute pancreatitis (SAP) often experience prolonged immobilization in the ICU, leading to complications such as ICU-acquired weakness (ICU-AW), extended hospital stays, and poor long-term functional outcomes. While early rehabilitation is beneficial in general critical care, its application in SAP is not well-established. This study was designed to address this gap by evaluating a comprehensive, structured early rehabilitation nursing (ERN) program. The program includes progressive mobilization, respiratory therapy, and psychological support, initiated within 48 hours of ICU admission. The hypothesis is that the ERN program, compared to usual care, will attenuate systemic inflammation, accelerate physical recovery, reduce length of stay, and lead to superior long-term functional independence, quality of life, and 1-year survival in patients with SAP.
- Conditions
- Severe Acute Pancreatitis Patients
- Being tested
- Structured Early Rehabilitation Nursing Program, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Early Rehabilitation Nursing ProgramBehavioural
A protocolized, phased program. Phase 1 (unconscious): passive range of motion and repositioning. Phase 2 (awake/stable): respiratory training (deep breathing, incentive spirometry), bed mobility (bridging, rolling), and progressive mobilization (sitting at edge of bed). Phase 3 (active): in-place stepping and supervised ambulation. Psychological support was provided throughout. Safety criteria were monitored continuously.
Usual CareOther
Standard ICU management for SAP as directed by the primary ICU team. Rehabilitation was discretionary, typically limited to passive range of motion exercises by bedside nurses if deemed necessary.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Early Rehabilitation Nursing (ERN) Group | Experimental | In addition to usual care, patients received a protocolized, multidisciplinary rehabilitation program initiated within 48 hours of ICU admission. The program consisted of progressive, goal-directed mobilization, respiratory therapy, and psychological support, delivered 7 days a week by trained nurses and physical therapists. Receives: Behavioral: Structured Early Rehabilitation Nursing Program |
| Active Comparator: Usual Care Group | Active comparator | Patients received standard ICU care for SAP, including hemodynamic monitoring, mechanical ventilation, fluid management, nutritional support, and pain control. Rehabilitation was not protocolized and was provided only at the discretion of the treating physician. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Length of Stay (LOS)
Defined as the time from ICU admission to discharge, measured in days.
Measured: From ICU admission to ICU discharge (assessed up to 90 days)
Hospital Length of Stay (LOS)
Defined as the total time from hospital admission to discharge, measured in days.
Measured: From hospital admission to hospital discharge (assessed up to 90 days)
Secondary outcomes (8)
Change in C-reactive protein (CRP) level
Serum levels of CRP, measured in mg/L, to assess systemic inflammation.
Measured: Baseline, Day 7
Change in Interleukin-6 (IL-6) level
Serum levels of IL-6, measured in pg/mL, to assess systemic inflammation.
Measured: Baseline, Day 7
Muscle Strength
Assessed using the Medical Research Council (MRC) sum score, which ranges from 0 (complete paralysis) to 60 (normal strength). A score <48 indicates ICU-acquired weakness.
Measured: At ICU discharge (within 24 hours prior to transfer from ICU)
Change in Functional Independence
Assessed using the Barthel Index for Activities of Daily Living (ADL). The score ranges from 0 to 100, where higher scores indicate greater independence.
Measured: Baseline (at ICU admission), at hospital discharge, and at 3, 6, and 12 months post-discharge
Change in Quality of Life
Measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) instrument, which assesses physical health, psychological health, social relationships, and environment domains. Domain scores are transformed to a 0-100 scale, where higher scores indicate better quality of life.
Measured: Baseline (at ICU admission), at hospital discharge, and at 3, 6, and 12 months post-discharge
One-Year All-Cause Mortality
Number of deaths from any cause within 12 months of randomization.
Measured: Up to 12 months
Incidence of ICU-Acquired Complications
Number of patients experiencing pre-specified complications, including pressure ulcers, ventilator-associated pneumonia, and deep vein thrombosis.
Measured: During ICU stay
Patient and/or Family Satisfaction
Assessed using a validated 5-point Likert scale at discharge. The scale measures satisfaction with nursing care, ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction.
Measured: At hospital discharge (within 24 hours prior to discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Jun 2019
- Primary completion1 Jun 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Pancreatitis PatientsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiandi Huang, Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109921
- Sponsor's protocol ID
- WHSHIRB-K-2019015
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Structured Early Rehabilitation Program on Long-Term Functional Recovery, Quality of Life, and Survival in Patients With Severe Acute Pancreatitis: A 5-Year Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07109921
- Acronym / sponsor ID
- WHSHIRB-K-2019015
- Conditions
- Severe Acute Pancreatitis Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 7 Aug 2025 (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.
This prospective, randomized controlled trial investigates the efficacy of a structured early rehabilitation nursing (ERN) program compared to usual care in patients with severe acute pancreatitis (SAP). Four hundred patients admitted to the intensive care unit (ICU) were randomized to either receive the ERN intervention or usual care. The study aims to evaluate the effects of ERN on ICU and hospital length of stay, systemic inflammation, physical function, long-term quality of life, and one-year survival.
Detailed description
Patients with severe acute pancreatitis (SAP) often experience prolonged immobilization in the ICU, leading to complications such as ICU-acquired weakness (ICU-AW), extended hospital stays, and poor long-term functional outcomes. While early rehabilitation is beneficial in general critical care, its application in SAP is not well-established. This study was designed to address this gap by evaluating a comprehensive, structured early rehabilitation nursing (ERN) program. The program includes progressive mobilization, respiratory therapy, and psychological support, initiated within 48 hours of ICU admission. The hypothesis is that the ERN program, compared to usual care, will attenuate systemic inflammation, accelerate physical recovery, reduce length of stay, and lead to superior long-term functional independence, quality of life, and 1-year survival in patients with SAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Early Rehabilitation Nursing (ERN) Group | Experimental | Behavioral: Structured Early Rehabilitation Nursing ProgramIn addition to usual care, patients received a protocolized, multidisciplinary rehabilitation program initiated within 48 hours of ICU admission. The program consisted of progressive, goal-directed mobilization, respiratory therapy, and psychological support, delivered 7 days a week by trained nurses and physical therapists. |
| Active Comparator: Usual Care Group | Active comparator | Other: Usual CarePatients received standard ICU care for SAP, including hemodynamic monitoring, mechanical ventilation, fluid management, nutritional support, and pain control. Rehabilitation was not protocolized and was provided only at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 75 years.
- A diagnosis of SAP according to the 2012 revised Atlanta classification.
- Admission to the ICU within 72 hours of symptom onset.
- An anticipated ICU stay of more than 48 hours.
Key exclusion criteria (6 listed)
- Pre-existing conditions precluding rehabilitation (e.g., severe neuromuscular disease, unstable spinal fractures).
- Acute myocardial infarction or unstable cardiac arrhythmia.
- Intracranial hypertension.
- Active gastrointestinal bleeding.
- Pregnancy.
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 |
|---|---|---|
| Structured Early Rehabilitation Nursing ProgramA protocolized, phased program. Phase 1 (unconscious): passive range of motion and repositioning. Phase 2 (awake/stable): respiratory training (deep breathing, incentive spirometry), bed mobility (bridging, rolling), and progressive mobilization (sitting at edge of bed). Phase 3 (active): in-place stepping and supervised ambulation. Psychological support was provided throughout. Safety criteria were monitored continuously. | Behavioural | Experimental: Early Rehabilitation Nursing (ERN) Group |
| Usual CareStandard ICU management for SAP as directed by the primary ICU team. Rehabilitation was discretionary, typically limited to passive range of motion exercises by bedside nurses if deemed necessary. | Other | Active Comparator: Usual Care Group |
Primary outcome
ICU Length of Stay (LOS)
Time frame: From ICU admission to ICU discharge (assessed up to 90 days)
Defined as the time from ICU admission to discharge, measured in days.
Hospital Length of Stay (LOS)
Time frame: From hospital admission to hospital discharge (assessed up to 90 days)
Defined as the total time from hospital admission to discharge, measured in days.
8 secondary outcomes
Change in C-reactive protein (CRP) level
Time frame: Baseline, Day 7
Change in Interleukin-6 (IL-6) level
Time frame: Baseline, Day 7
Muscle Strength
Time frame: At ICU discharge (within 24 hours prior to transfer from ICU)
Change in Functional Independence
Time frame: Baseline (at ICU admission), at hospital discharge, and at 3, 6, and 12 months post-discharge
Change in Quality of Life
Time frame: Baseline (at ICU admission), at hospital discharge, and at 3, 6, and 12 months post-discharge
One-Year All-Cause Mortality
Time frame: Up to 12 months
Incidence of ICU-Acquired Complications
Time frame: During ICU stay
Patient and/or Family Satisfaction
Time frame: At hospital discharge (within 24 hours prior to discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Early Rehabilitation Nursing Program in people with Severe Acute Pancreatitis Patients, run by Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University 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 6 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: finished, as of the sponsor's last update on 7 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Length of Stay (LOS) (time frame: From ICU admission to ICU discharge (assessed up to 90 days)). The study lists 2 primary outcomes in all. 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 7 Aug 2025.