Clinical trial NCT06351280: Evaluation of Performance-based Functional Outcome Measures After Open Abdominal Surgery
Official title: Evaluation of Performance-based Functional Outcome Measures After Open Abdominal Surgery: a Comparison of Clinimetric Properties of Four Tools
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparotomy
Keywords: Post operative laparotomy, cardiopulmonary functionality
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6MWT (Six-Minute Walk Test)
timeFrame: 1 week
measure: 5 Times Sit to Stand
timeFrame: 1 week
measure: 2MWT (Two-Minute Walk Test)
timeFrame: 1 week
measure: Timed Up and GO (TUG)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fauji Foundation Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Suman Sheraz, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: . 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.