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NCT Number: NCT06351280

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

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.

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Key information

Conditions

Laparotomy

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fauji Foundation Hospital

Rawalpindi, Punjab Province, 00666, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Standardised Physiotherapy Plan

Other

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.

Primary outcomes

  1. 6MWT (Six-Minute Walk Test)

    Time frame: 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.

  2. 5 Times Sit to Stand

    Time frame: 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

  3. 2MWT (Two-Minute Walk Test)

    Time frame: 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.

  4. Timed Up and GO (TUG)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Aug 14, 2024

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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