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

NCT ID: NCT06351280

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-07-30

Brief Summary

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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

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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.

Conditions

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Laparotomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Standardised Physiotherapy Plan

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suman Sheraz, PhD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Fauji Foundation Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 35609291 (View on PubMed)

. 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.

Reference Type BACKGROUND

Other Identifiers

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Sana Nasir Zaidi

Identifier Type: -

Identifier Source: org_study_id

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