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NCT Number: NCT07109921

Early Rehabilitation for Severe Acute Pancreatitis (ERN-SAP)

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.

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Key information

Conditions

Severe Acute Pancreatitis Patients

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University

Wuhan, Hubei, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Structured Early Rehabilitation Nursing Program

Behavioral

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 Care

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in C-reactive protein (CRP) level

    Time frame: Baseline, Day 7

    Serum levels of CRP, measured in mg/L, to assess systemic inflammation.

  2. Change in Interleukin-6 (IL-6) level

    Time frame: Baseline, Day 7

    Serum levels of IL-6, measured in pg/mL, to assess systemic inflammation.

  3. Muscle Strength

    Time frame: At ICU discharge (within 24 hours prior to transfer from ICU)

    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.

  4. Change in Functional Independence

    Time frame: Baseline (at ICU admission), at hospital discharge, and at 3, 6, and 12 months post-discharge

    Assessed using the Barthel Index for Activities of Daily Living (ADL). The score ranges from 0 to 100, where higher scores indicate greater independence.

  5. Change in Quality of Life

    Time frame: Baseline (at ICU admission), at hospital discharge, and at 3, 6, and 12 months post-discharge

    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.

  6. One-Year All-Cause Mortality

    Time frame: Up to 12 months

    Number of deaths from any cause within 12 months of randomization.

  7. Incidence of ICU-Acquired Complications

    Time frame: During ICU stay

    Number of patients experiencing pre-specified complications, including pressure ulcers, ventilator-associated pneumonia, and deep vein thrombosis.

  8. Patient and/or Family Satisfaction

    Time frame: At hospital discharge (within 24 hours prior to discharge)

    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.

Sponsors and collaborators

Lead sponsor

Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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