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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparotomy
• Intervention / Treatment: Other: Standardised Physiotherapy Plan

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suman Sheraz, PhD; Phone Number: 03335646361; Email: suman.sheraz@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 00666
      • Fauji Foundation Hospital
      • Contact: Suman Sheraz, PhD*; Phone Number: 03335646361; Email: suman.sheraz@riphah.edu.pk
      • Principal Investigator: Suman Sheraz, PhD*
      • Sub-Investigator: Sana Nasir, MS-CPPT*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Functionality Assessment; Each participant will be provided with an informed consent form detailing the purpose of the study. After obtaining written consent, baseline data will be collected, including demographic information, medical history, and any pre-existing conditions. The participants will then undergo the post-laparotomy interventions as described. Throughout the intervention period, data will be collected using the tools mentioned: 6 minute Walk Test, 5 Times Sit to Stand test, 2 Minute walk Test, and Timed Up and GO to determine any changes in their functionality and overall well-being on post operative day 1 and before discharge. For reliability, tests will be conducted twice a day with a minimum gap of 2 hours, both on day 1 and on the day of discharge.

Other: Standardised 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6MWT (Six-Minute Walk Test)	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.	1 week
5 Times Sit to Stand	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	1 week
2MWT (Two-Minute Walk Test)	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.	1 week
Timed Up and GO (TUG)	. 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.	1 week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Suman Sheraz, PhD*, Riphah International University

Publications and helpful links

General Publications

• Boden I, Sullivan K, Hackett C, Winzer B, Hwang R, Story D, Denehy L. Intensive physical therapy after emergency laparotomy: Pilot phase of the Incidence of Complications following Emergency Abdominal surgery Get Exercising randomized controlled trial. J Trauma Acute Care Surg. 2022 Jun 1;92(6):1020-1030. doi: 10.1097/TA.0000000000003542. Epub 2022 Jan 18.
• . Li AM, Yin J, Yu C, Tsang T, So H, Wong E, et al. The six-minute walk test in healthy children: reliability and validity. 2005;25(6):1057-60. 16. Goldberg A, Chavis M, Watkins J, Wilson TJAc, research e. The five-times-sit-to-stand test: validity, reliability and detectable change in older females. 2012;24:339-44. 17. Cristina da Silva L, Danielli Coelho de Moraes Faria C, da Cruz Peniche P, Ayessa Ferreira de Brito S, Tavares Aguiar LJTiSR. Validity of the two-minute walk test to assess exercise capacity and estimate cardiorespiratory fitness in individuals after stroke: a cross-sectional study. 2023:1-10. 18. Bohannon RW, Wang Y-C, Gershon RCJAopm, rehabilitation. Two-minute walk test performance by adults 18 to 85 years: normative values, reliability, and responsiveness. 2015;96(3):472-7.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Post operative laparotomy, cardiopulmonary functionality
• Other Study ID Numbers: Sana Nasir Zaidi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No