Evaluation of Performance-based Functional Outcome Measures After Open Abdominal Surgery

Not Applicable

Completed

• Conditions: Laparotomy

• Registration Number: NCT06351280
• Lead Sponsor: Riphah International University

Brief Summary

A laparotomy is a surgical technique, the increasing rate of this surgical interventions and the subsequent need to evaluate the post-surgical recovery and rehabilitation process comprehensively. This study aims to provide essential insights into the reliability, validity, and responsiveness of such tests, enabling healthcare professionals to make informed decisions about patient recovery progress and the optimization of rehabilitation protocols.

Detailed Description

The significance of this research lies in its potential to enhance the quality of care and patient outcomes, reduce healthcare costs, and contribute to evidence-based decision-making in postsurgical rehabilitation, ultimately improving the overall well-being of surgical patients. This study is to evaluate the clinimetric properties of four distinct tools designed for assessing performance-based functional outcomes following open abdominal surgery. 6 Minute Walk Test (6MWT), 5 Times Sit to Stand test (5T STS), 2 minute Walk test (2MWT), and Timed Up and GO (TUG)will be assessed to determine any changes in their functionality and overall well-being on day 2 and on day of discharge.

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-08
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Post-laparotomy patients
• Hemodynamically stable
• Age between 30 to 60 years
• Ambulatory patients
• Patients score 1

Exclusion Criteria

• Incidence of adverse events through hemodynamic and medication data.
• Diagnosed cognitive dysfunction.
• Diagnosed neurologic or musculoskeletal disease (excluding osteoarthritis) adversely affecting gait or weight-bearing.
• History of Orthostatic intolerance.
• History of recent fractures, blunt trauma emergency laparotomy, carcinoma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
6MWT (Six-Minute Walk Test)	1 week	A submaximal exercise test called the 6MWT is used to measure aerobic capacity and endurance. This test's main goal is for the patient to walk as far as they can in six minutes.; 6MWT (Six-Minute Walk Test) A submaximal exercise test called the 6MWT is used to measure aerobic capacity and endurance. The distance (measured in meters) traveled during the six minutes allotted for the test determines the score.
5 Times Sit to Stand	1 week	The test can be used to track the course of an illness or the effectiveness of a therapeutic intervention in addition to providing useful information about a person's functional ability. The distance (measured in meters) traveled during the six minutes allotted for the test determines the score. Greater aerobic endurance and functional capacity are indicated by a longer distance
Timed Up and GO (TUG)	1 week	. It is designed to assess an individual's mobility and requires the participant to stand up from a seated position, walk a distance of three meters, turn around, walk back to the chair, and sit down.
2MWT (Two-Minute Walk Test)	1 week	The 2MWT is a functional exercise test designed to evaluate an individual's aerobic capacity and endurance over a shorter duration compared to the 6MWT.

Trial Locations

Locations (1)

Fauji Foundation Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan