Impact of Lung Function Prehabilitation to Postoperative Pulmonary Complications

March 5, 2025 updated by: Dita Aditianingsih, Indonesia University

The Impact of Lung Function Prehabilitation to Postoperative Pulmonary Complications on Patient Undergoing Upper Abdominal Surgery Treated in Intensive Care Unit: A Randomized Controlled Trial

The aim of this study is to compare the effect of lung function prehabilitation to postoperative pulmonary complications on patient undergoing upper abdominal surgery treated in intensive care unit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 10430
        • RSUPN Dr. Cipto Mangunkusumo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • adults 18 years or older
  • scheduled for the upper abdominal surgery under general anesthesia with intraoperative mechanical ventilation
  • possess adequate cognitive function to comprehend and follow instructions
  • possess sufficient physical capacity to perform structured prehabilitation exercises
  • express willingness to participate in the intervention program before surgery

Exclusion Criteria:

  • pregnancy
  • pre-existing severe pulmonary diseases such as chronic obstructive pulmonary disease (COPD)
  • planned laparoscopic procedures
  • history of significant neuromuscular impairment (e.g: stroke)
  • declined to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lung Function Prehabilitation
Participants assigned to the prehabilitation group received personalized exercise prescriptions, including aerobic training, muscle strengthening, and inspiratory muscle training with a threshold device. The prehabilitation program was conducted at the participants' homes for a minimum duration of two weeks. Adherence was monitored through logbook entries and video call evaluations to ensure correct implementation of the prescribed exercises.
Procedure: Lung Function Prehabilitation
Participants assigned to the prehabilitation group received personalized exercise prescriptions, including aerobic training, muscle strengthening, and inspiratory muscle training with a threshold device. The prehabilitation program was conducted at the participants' homes for a minimum duration of two weeks. Adherence was monitored through logbook entries and video call evaluations to ensure correct implementation of the prescribed exercises.
No Intervention: Standard of Care
No prehabilitation is done, patients in this group received standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pulmonary complications
Time Frame: Postoperative day 1 and 3
Including pulmonary infections, atelectasis, and diaphragmatic dysfunction. Pulmonary infection is assessed using the Clinical Pulmonary Infection Score (CPIS) and with a threshold of >6, atelectasis using Lung Ultrasound Score (LUS) of ≥1, and diaphragm ultrasound were used to evaluate diaphragm ratio. CPIS and LUS score assessments were conducted on postoperative day 1 and 3 by trained investigators, diaphragm ratio assessment was conducted preoperatively and on postoperative day 1 and 3, all findings were systematically recorded.
Postoperative day 1 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

November 12, 2024

Study Registration Dates

First Submitted

March 1, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IndonesiaUAnes049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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