Impact of Lung Function Prehabilitation to Postoperative Pulmonary Complications

NCT06862076 | Completed

• 1 other identifier: IndonesiaUAnes049
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pulmonary Complications (PPCs)

Keywords

Prehabilitation; Postoperative pulmonary complications; Upper abdominal surgery; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• Postoperative pulmonary complications

  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

Study Arms (2)

Lung Function Prehabilitation

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

No prehabilitation is done, patients in this group received standard of care.

Interventions

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.

Lung Function Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSUPN dr. Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. dr. Dita Aditianingsih, Sp.An-TI., Subsp.T.I.(K).

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 6, 2025
• Study Start: August 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: November 12, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)