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Early Rehabilitation for Severe Acute Pancreatitis (ERN-SAP)

NCT07109921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-08-07

No results posted yet for this study

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). 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.

Conditions

  • Severe Acute Pancreatitis Patients

Interventions

BEHAVIORAL

Structured Early Rehabilitation Nursing Program

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.

OTHER

Usual Care

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.

Sponsors & Collaborators

  • Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2024-06-01
Completion
2025-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07109921 on ClinicalTrials.gov