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Completed

NCT Number: NCT06862076

Impact of Lung Function Prehabilitation to Postoperative Pulmonary Complications

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUPN dr. Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Lung Function Prehabilitation

Procedure

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2025
Registry last updated
Mar 6, 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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