Coronary Artery DiseaseNCT07060937
Clinimetric Properties of Performance Based Functional Outcome Measure After (CABG) Surgery
A study testing Physiotherapy Protocol in people with Coronary Artery Disease and CABG, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The purpose of this research is to determine which performance based functional outcome test among Time up and go test, Five times sit to stand test, 2 minute walk test and 6 minute walk test has the greatest significance in improving functional outcomes in post-CABG surgery patients. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Coronary Artery Disease, CABG
- What is being tested?
- Physiotherapy Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesPakistan
- Study dates
- 10 Dec 2025to 30 Apr 2026
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 30-50 years old
- Post-op CABG patients
- Include male and female both
- Mobile patients
- Post-op day 3 and day 5 of CABG surgery
Who cannot join
- Occurrence of adverse events
- Unstable hemodynamically
- Patients with documented cognitive dysfunction
- Patients with neurologic or musculoskeletal disease (excluding osteoarthritis) that adversely affects gait or weight-bearing
- Patients with severe co-morbidities, recurrent attacks, and unstable condition.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Armed Forces Institute of Cardiology
Rawalpindi, Punjab Province, 44000
Armed Forces Institute of Cardiology
Rawalpindi, Punjab Province, 46000
About this study
Official title: Clinimetric Properties of Performance Based Functional Outcome Measure After Coronary Artery Bypass Graft (CABG) Surgery
The purpose of this research is to determine which performance based functional outcome test among Time up and go test, Five times sit to stand test, 2 minute walk test and 6 minute walk test has the greatest significance in improving functional outcomes in post-CABG surgery patients.
Read the detailed description
Coronary artery disease is the leading cause of death worldwide and has adverse effects on functionality. It causes functional limitations which affects the cardiac output resulting in reduced morbidity and mortality. To improve the life expectancy, an invasive surgical procedure is done known as CABG. To reduce the chances of reoccurrence of coronary artery disease post- CABG surgery patients are enrolled in the Cardiac Rehab program which focuses on improving quality of life of the patient, to increase life expectancy, improve functional independence and reduce chances of graft failure. In Cardiac Rehabilitation our focus would be on identifying the performance based functional outcome measure test which demonstrates the greatest clinimetric significance in improving functional outcome measure in post- CABG patients. The four clinimetric tests used in this research are time up and go test, five times sit to stand test, 2 minute walk test and 6 minute walk test on post operative day 3 and day 5 respectively. The result of this research would indicate which test is most significant in enhancing functionality of post-CABG patients providing valuable and evidence-based approach for healthcare providers to design rehabilitation protocols.
- Conditions
- Coronary Artery Disease, CABG
- Being tested
- Physiotherapy Protocol
- Keywords
- Clinimetric properties, Performance based functional outcomes, Time up and go test, Five times sit to stand test, 2 minute walk test, 6 minute walk test
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy ProtocolOther
Each participant consenting to the study will be given a physiotherapy session on post-op day 1 and day 2 by a physiotherapist. The session will include bed mobility exercises including active ROM exercises of all extremities, breathing exercises, nebulization and chest physical therapy, incentive spirometer. Progressing to supported sitting at the edge of bed, sitting on a chair under supervision, supported walk inside the room , sitting independently in chair and lastly before discharge climbing 2 flights of stair.
| Study group | Role | What they receive |
|---|---|---|
| Post CABG surgery patients | Experimental | The intervention includes 30-50 years old male and female post-CABG surgery patients. They will be recruited according to the inclusion criteria of the study and all baseline measurements will be taken from each participant to ensure readiness for the tests performed. The participants will undergo functionality based performance tests which include 5 Time sit to stand test, Time up and go test, 2 Minute walk test and 6 Minute walk test on post-op day 3 and day 5 respectively. The test will be performed twice on post-op day 3 and post-op day 5 with 6 hours minimum gap in between to promote patient recovery and test re-test reliability. Participants pre-test and post-test vitals will be taken and their test outcomes readings will be noted on the self-administered questionnaire. Receives: Other: Physiotherapy Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time up and go test
On post op- day 3 and 5 Participants will quickly perform test to assess lower extremity strength and risk of fall. The time taken to complete test will be noted
Measured: 6 hours
Five times sit to stand test
On post-op day 3 and 5, Participants will perform test by transitioning from sitting to standing five times in row, time would be noted. This test helps to evaluate lower extremity balance and strength.
Measured: 6 hours
2 Minute walk test
The test will be performed on post-op day 3 and 5, the participants will walk on a flat surface in a straight line and the distance will be noted. This test assess endurance
Measured: 6 hours
6 Minute walk test
This is a self-paced test which will be performed on post-op day 3 and 5 where the participants have walk on a flat, smooth surface. The distance covered during this test will be noted. It measures aerobic capacity and endurance.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start10 Dec 2025
- Primary completion1 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT07060937
- Sponsor's protocol ID
- Zarish Ayub
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melo TA, Duarte ACM, Bezerra TS, Franca F, Soares NS, Brito D. The Five Times Sit-to-Stand Test: safety and reliability with older intensive care unit patients at discharge. Rev Bras Ter Intensiva. 2019;31(1):27-33. doi: 10.5935/0103-507X.20190006. Epub 2019 Mar 14.
PubMed 30892478Rodrigues F, Teixeira JE, Forte P. The Reliability of the Timed Up and Go Test among Portuguese Elderly. Healthcare (Basel). 2023 Mar 23;11(7):928. doi: 10.3390/healthcare11070928.
PubMed 37046858de Jesus SFC, Bassi-Dibai D, Pontes-Silva A, da Silva de Araujo A, de Freitas Faria Silva S, Veneroso CE, de Paula Gomes CAF, Dibai-Filho AV. Construct validity and reliability of the 2-Minute Step Test (2MST) in individuals with low back pain. BMC Musculoskelet Disord. 2022 Dec 5;23(1):1062. doi: 10.1186/s12891-022-06050-w.
PubMed 36471309Giannitsi S, Bougiakli M, Bechlioulis A, Kotsia A, Michalis LK, Naka KK. 6-minute walking test: a useful tool in the management of heart failure patients. Ther Adv Cardiovasc Dis. 2019 Jan-Dec;13:1753944719870084. doi: 10.1177/1753944719870084.
PubMed 31441375Essop-Adam A, Daynes E, Houghton JSM, Nickinson ATO, Sayers RDS, Haunton VJ, Pepper C, Singh SJ. Clinimetrics of performance-based functional outcome measures for vascular amputees: A systematic review. Ann Phys Rehabil Med. 2023 Sep;66(6):101756. doi: 10.1016/j.rehab.2023.101756. Epub 2023 Jun 3.
PubMed 37276748Osailan A, Abdelbasset WK. Exercise-based cardiac rehabilitation for postcoronary artery bypass grafting and its effect on hemodynamic responses and functional capacity evaluated using the Incremental Shuttle Walking Test: A retrospective pilot analysis. J Saudi Heart Assoc. 2020 Apr 17;32(1):25-33. doi: 10.37616/2212-5043.1005. eCollection 2020.
PubMed 33154888Puri SN, Lalwani L. A Comparison Between Cardiac Telerehabilitation Program and Outpatient Hospital-Based Cardiac Rehabilitation Program for Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery: A Review. Cureus. 2023 Nov 8;15(11):e48488. doi: 10.7759/cureus.48488. eCollection 2023 Nov.
PubMed 38073989
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinimetric Properties of Performance Based Functional Outcome Measure After Coronary Artery Bypass Graft (CABG) Surgery
- ClinicalTrials.gov ID
- NCT07060937
- Acronym / sponsor ID
- Zarish Ayub
- Conditions
- Coronary Artery Disease, CABG
- Keywords
- Clinimetric properties, Performance based functional outcomes, Time up and go test, Five times sit to stand test, 2 minute walk test, 6 minute walk test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 11 Jul 2025 (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.
The purpose of this research is to determine which performance based functional outcome test among Time up and go test, Five times sit to stand test, 2 minute walk test and 6 minute walk test has the greatest significance in improving functional outcomes in post-CABG surgery patients.
Detailed description
Coronary artery disease is the leading cause of death worldwide and has adverse effects on functionality. It causes functional limitations which affects the cardiac output resulting in reduced morbidity and mortality. To improve the life expectancy, an invasive surgical procedure is done known as CABG. To reduce the chances of reoccurrence of coronary artery disease post- CABG surgery patients are enrolled in the Cardiac Rehab program which focuses on improving quality of life of the patient, to increase life expectancy, improve functional independence and reduce chances of graft failure. In Cardiac Rehabilitation our focus would be on identifying the performance based functional outcome measure test which demonstrates the greatest clinimetric significance in improving functional outcome measure in post- CABG patients. The four clinimetric tests used in this research are time up and go test, five times sit to stand test, 2 minute walk test and 6 minute walk test on post operative day 3 and day 5 respectively. The result of this research would indicate which test is most significant in enhancing functionality of post-CABG patients providing valuable and evidence-based approach for healthcare providers to design rehabilitation protocols.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post CABG surgery patients | Experimental | Other: Physiotherapy ProtocolThe intervention includes 30-50 years old male and female post-CABG surgery patients. They will be recruited according to the inclusion criteria of the study and all baseline measurements will be taken from each participant to ensure readiness for the tests performed. The participants will undergo functionality based performance tests which include 5 Time sit to stand test, Time up and go test, 2 Minute walk test and 6 Minute walk test on post-op day 3 and day 5 respectively. The test will be performed twice on post-op day 3 and post-op day 5 with 6 hours minimum gap in between to promote patient recovery and test re-test reliability. Participants pre-test and post-test vitals will be taken and their test outcomes readings will be noted on the self-administered questionnaire. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 30-50 years old
- Post-op CABG patients
- Include male and female both
- Mobile patients
- Post-op day 3 and day 5 of CABG surgery
Key exclusion criteria (5 listed)
- Occurrence of adverse events
- Unstable hemodynamically
- Patients with documented cognitive dysfunction
- Patients with neurologic or musculoskeletal disease (excluding osteoarthritis) that adversely affects gait or weight-bearing
- Patients with severe co-morbidities, recurrent attacks, and unstable condition.
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 |
|---|---|---|
| Physiotherapy ProtocolEach participant consenting to the study will be given a physiotherapy session on post-op day 1 and day 2 by a physiotherapist. The session will include bed mobility exercises including active ROM exercises of all extremities, breathing exercises, nebulization and chest physical therapy, incentive spirometer. Progressing to supported sitting at the edge of bed, sitting on a chair under supervision, supported walk inside the room , sitting independently in chair and lastly before discharge climbing 2 flights of stair. | Other | Post CABG surgery patients |
Primary outcome
Time up and go test
Time frame: 6 hours
On post op- day 3 and 5 Participants will quickly perform test to assess lower extremity strength and risk of fall. The time taken to complete test will be noted
Five times sit to stand test
Time frame: 6 hours
On post-op day 3 and 5, Participants will perform test by transitioning from sitting to standing five times in row, time would be noted. This test helps to evaluate lower extremity balance and strength.
2 Minute walk test
Time frame: 6 hours
The test will be performed on post-op day 3 and 5, the participants will walk on a flat surface in a straight line and the distance will be noted. This test assess endurance
6 Minute walk test
Time frame: 6 hours
This is a self-paced test which will be performed on post-op day 3 and 5 where the participants have walk on a flat, smooth surface. The distance covered during this test will be noted. It measures aerobic capacity and endurance.
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 20 Jul 2026.
- Background: PubMed 30892478Melo TA, Duarte ACM, Bezerra TS, Franca F, Soares NS, Brito D. The Five Times Sit-to-Stand Test: safety and reliability with older intensive care unit patients at discharge. Rev Bras Ter Intensiva. 2019;31(1):27-33. doi: 10.5935/0103-507X.20190006. Epub 2019 Mar 14.
- Background: PubMed 37046858Rodrigues F, Teixeira JE, Forte P. The Reliability of the Timed Up and Go Test among Portuguese Elderly. Healthcare (Basel). 2023 Mar 23;11(7):928. doi: 10.3390/healthcare11070928.
- Background: PubMed 36471309de Jesus SFC, Bassi-Dibai D, Pontes-Silva A, da Silva de Araujo A, de Freitas Faria Silva S, Veneroso CE, de Paula Gomes CAF, Dibai-Filho AV. Construct validity and reliability of the 2-Minute Step Test (2MST) in individuals with low back pain. BMC Musculoskelet Disord. 2022 Dec 5;23(1):1062. doi: 10.1186/s12891-022-06050-w.
- Background: PubMed 31441375Giannitsi S, Bougiakli M, Bechlioulis A, Kotsia A, Michalis LK, Naka KK. 6-minute walking test: a useful tool in the management of heart failure patients. Ther Adv Cardiovasc Dis. 2019 Jan-Dec;13:1753944719870084. doi: 10.1177/1753944719870084.
- Background: PubMed 37276748Essop-Adam A, Daynes E, Houghton JSM, Nickinson ATO, Sayers RDS, Haunton VJ, Pepper C, Singh SJ. Clinimetrics of performance-based functional outcome measures for vascular amputees: A systematic review. Ann Phys Rehabil Med. 2023 Sep;66(6):101756. doi: 10.1016/j.rehab.2023.101756. Epub 2023 Jun 3.
- Background: PubMed 33154888Osailan A, Abdelbasset WK. Exercise-based cardiac rehabilitation for postcoronary artery bypass grafting and its effect on hemodynamic responses and functional capacity evaluated using the Incremental Shuttle Walking Test: A retrospective pilot analysis. J Saudi Heart Assoc. 2020 Apr 17;32(1):25-33. doi: 10.37616/2212-5043.1005. eCollection 2020.
- Background: PubMed 38073989Puri SN, Lalwani L. A Comparison Between Cardiac Telerehabilitation Program and Outpatient Hospital-Based Cardiac Rehabilitation Program for Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery: A Review. Cureus. 2023 Nov 8;15(11):e48488. doi: 10.7759/cureus.48488. eCollection 2023 Nov.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy Protocol in people with Coronary Artery Disease and CABG, run by Riphah International University at 2 sites 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Time up and go test (time frame: 6 hours). 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 NCT07060937, which also lists 7 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 20 Jul 2026.