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

Evaluation of Performance-based Functional Outcome Measures After Open Abdominal Surgery: a Comparison of Clinimetric Properties of Four Tools

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06351280
Enrollment
50
Registered
2024-04-08
Start date
2024-04-01
Completion date
2024-07-30
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparotomy

Keywords

Post operative laparotomy, cardiopulmonary functionality

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.

Interventions

OTHERStandardised Physiotherapy Plan

Single session of coached deep breathing and coughing exercises. 10 supervised slow flow deep breaths to total lung capacity with a 3-5 second end inspiratory hold completed with 2 end inspiratory sniffs. 2-3 supported coughs or huffs. Repeated for another set. Patients instructed to perform independently hourly. Assisted ambulation according to the following protocol: * Stage 1 of 2 minutes. * Stage 2 of 0-1 minute. * Stage 3 of 1 - 3 minutes. * Stage 4 of 3 - 6 minutes. * Stage 5 of 6 - 10 minutes. * Stage 6 of 10 - 15 minutes. * Stage 7 \> 15 minutes. Total session time is the accumulative work time.

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
6MWT (Six-Minute Walk Test)1 weekA 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 Stand1 weekThe 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
2MWT (Two-Minute Walk Test)1 weekThe 2MWT is a functional exercise test designed to evaluate an individual's aerobic capacity and endurance over a shorter duration compared to the 6MWT.
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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026