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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
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.
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.
The Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
Wuhan, Hubei, China
ICU Length of Stay (LOS)
Defined as the time from ICU admission to discharge, measured in days.
Time frame: 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.
Time frame: From hospital admission to hospital discharge (assessed up to 90 days)
Change in C-reactive protein (CRP) level
Serum levels of CRP, measured in mg/L, to assess systemic inflammation.
Time frame: Baseline, Day 7
Change in Interleukin-6 (IL-6) level
Serum levels of IL-6, measured in pg/mL, to assess systemic inflammation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At hospital discharge (within 24 hours prior to discharge)