LaparotomyNCT06351280
Evaluation of Performance-based Functional Outcome Measures After Open Abdominal Surgery
A study testing Standardised Physiotherapy Plan in people with Laparotomy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Laparotomy
- What is being tested?
- Standardised Physiotherapy Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Post-laparotomy patients
- Hemodynamically stable
- Age between 30 to 60 years
- Ambulatory patients
- Patients score 1
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Laparotomy
- Being tested
- Standardised Physiotherapy Plan
- Keywords
- Post operative laparotomy, cardiopulmonary functionality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised Physiotherapy PlanOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Functionality Assessment | Other | 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. Receives: Other: Standardised Physiotherapy Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351280
- Sponsor's protocol ID
- Sana Nasir Zaidi
- Status last verified
- Aug 2024
- First submitted
- 2 Apr 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35609291. 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 at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance-based Functional Outcome Measures After Open Abdominal Surgery: a Comparison of Clinimetric Properties of Four Tools
- ClinicalTrials.gov ID
- NCT06351280
- Acronym / sponsor ID
- Sana Nasir Zaidi
- Conditions
- Laparotomy
- Keywords
- Post operative laparotomy, cardiopulmonary functionality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functionality Assessment | Other | Other: Standardised Physiotherapy PlanEach 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Post-laparotomy patients
- Hemodynamically stable
- Age between 30 to 60 years
- Ambulatory patients
- Patients score 1
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardised Physiotherapy PlanSingle 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. | Other | Functionality Assessment |
Primary outcome
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.
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Background: PubMed 35609291Boden 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.
- Background. 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Sheraz, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardised Physiotherapy Plan in people with Laparotomy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWT (Six-Minute Walk Test) (time frame: 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06351280, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.