Cardiac SurgeryCardiostepNCT05166863
Physical Performance Testing and Frailty in Prediction of Early Postoperative Course After Cardiac Surgery
An observational study of Cardiac Surgery and Rehabilitation, run by Jan Gofus, MD, PhD at 1 site in Czechia.
Trial summary
Standard risk prediction models in cardiac surgery (such as EuroSCORE II or STS score) are designed to analyze solely the risk of short-term postoperative mortality. The postoperative morbidity, the ability to rehabilitate or the mid-term survival are not addressed by these means. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiac Surgery, Rehabilitation, Frailty
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 29 Apr 2021to 30 Dec 2024
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for non-complex elective cardiac surgery at a single tertiary care cardiovascular center in the Czech Republic.
Who may be able to join
- informed patient consent
- patient scheduled for an elective cardiac surgery. The following procedures are accepted: coronary artery bypass grafting (CABG) , single valve replacement (SVR), CABG + SVR, CABG + MAZE procedure, SVR + MAZE procedure
- since June 2021, patients undergoing double-valve surgery have been allowed to be included in the study to promote patients inclusion
Who cannot join
- complex cardiac surgery (except the options listed above)
- ejection fraction of the left ventricle < 30 % according to the last preoperative echocardiography
- EuroSCORE II value > 5 %
- urgent or emergent surgery
- patient unable to walk and/or perform the test
- severe dementia (due to unability to cooperate during the testing and follow-up)
- re-do surgery
- minimally invasive surgery (i.e. other than full median sternotomy)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Hradec Králové
Hradec Králové, Královehradecký Kraj, 500 02
About this study
Standard risk prediction models in cardiac surgery (such as EuroSCORE II or STS score) are designed to analyze solely the risk of short-term postoperative mortality. The postoperative morbidity, the ability to rehabilitate or the mid-term survival are not addressed by these means. Recently there have been some reports that addition of physical performance testing to the standard prediction models may provide prognostic value. There is a wide scale of various physical performance and frailty tests that could be used for this purpose, but they have not been confronted with each other yet. Moreover, the postoperative physical rehabilitation has not been objectively assessed in larger scale despite the significant improvement in technology.
The hypothesisis of the study is that the preoperative outcomes of physical performance and frailty testing are able to predict the patient's reconvalescence after cardiac surgery in the short- and mid-term postoperatively. The aim is to analyze a set of tests with regard to their ability to predict postoperative reconvalescence, including the objective activity assessment (using Actigraph wGT3X-BT activity tracking device). Secondarily, the investigators aim to follow the patients up to 1 year postoperatively in terms of evaluating their mid-term outcomes.
Read the detailed description
Detailed description of testing performed in the exact order as in the patient:
- Body weight and body composition (weigth of fat, weigth of muscle) measurement using bioimpendance scale Tanita BC 545N.
- Katz Index of Independence in Activites of Daily Living performed and assessed exactly as described elsewhere.
- Hand-grip strength test using the Kern MAP 80K1 device. Modified Southhampton protocol will be used for the measurement: Patient is sitting on a chair without side arms, the elbows are in a right angle. The patient is instructed to squeeze the device as much as possible and hold for 3 seconds. He squeezes the device with the right hand, then with the left hand. This is performed two times with each hand in total. The highest measured value is recorded.
- 5-meter gait test. Patient is instructed to walk the 5-meter line as fast as possible and the time is being measured. This is repeated three times. Average time of the three attempts is recorded.
- 6-minute walk test. Patient is instructed to walk without interruption for 6 minutes in the corridor of department's standard ward (exactly 36 meters long). He walks there and back repeatedly and the walked distance is calculated with regard to the number of corridors walked.
- During the last two tests patient is wearing a pulse oxymeter (Berry BM1000C) that is connected with investigator's smartphone (either Android or iOS) through bluetooth. Eventual latent respiratory failure is recorded, defined as a drop in peripheral saturation of 4 % and more, or under 88 %.
- Pre-defined set of laboratory blood tests: haemoglobin, creatinin, albumin, TSH, free T3, free T4.
- Conditions
- Cardiac Surgery, Rehabilitation, Frailty, Physical Performance
- Keywords
- surgery, rehabilitation, frailty, performance, activity
- Medical subject headings
- Frailty, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard postoperative measures of patient reconvalescence
To analyze the ability of preoperative physical performance and frailty tests to predict the standard postoperative measures of patient reconvalescence: length of artificial ventilation, length of stay in the intensive care unit, total postoperative hospital stay.
Measured: Usually up to 30 days postoperatively
Objective postoperative patient activity tracking
To analyze the ability of preoperative physical performance and frailty tests to predict the outcomes of objective postoperative patient activity tracking by the means of total number of steps taken during the first 4 days in the standard ward and total intensity of physical activity in this time period, both measured by the dedicated wearable Actigraph activity monitor.
Measured: First 4 postoperative days in the standard ward
Secondary outcomes (2)
The dynamics of physical performance in the mid-term postoperatively
To repeat the set of preoperative physical and frailty tests in pre-specified time intervals after the surgery: on 7th postoperative day, 3 months after the surgery and 1 year after the surgery. Thereafter, the investigators aim to evaluate the dynamics of the outcomes and eventual predictive value of the preoperative outcomes.
Measured: 1 year postoperatively
Mid-term postoperative mortality, major adverse events, cardiac rehospitalizations
To analyze the ability of preoperative physical performance and frailty tests to predict the 1-year (mid-term) postoperative mortality, major adverse cardiac and cerebrovascular events and the risk of rehospitalizations for cardiac reasons.
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start29 Apr 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Gofus, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Charles University, Czech Republic
- Responsible party
- Sponsor-investigator, Jan Gofus, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Ján Gofus, MD, PhD, Principal investigator, University Hospital Hradec KrálovéJan Vojáček, Professor, MD, PhD, Study chair, University Hospital Hradec Králové
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166863
- Sponsor's protocol ID
- 202010 P07
- Acronym
- Cardiostep
- Status last verified
- May 2024
- First submitted
- 8 Dec 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The anonymized individual patient data will be shared upon a reasonable request to the principal study investigator.
Publications
de Arenaza DP, Pepper J, Lees B, Rubinstein F, Nugara F, Roughton M, Jasinski M, Bazzino O, Flather M; ASSERT (Aortic Stentless versus Stented valve assessed by Echocardiography Randomised Trial) Investigators. Preoperative 6-minute walk test adds prognostic information to Euroscore in patients undergoing aortic valve replacement. Heart. 2010 Jan;96(2):113-7. doi: 10.1136/hrt.2008.161174. Epub 2009 Jun 28.
PubMed 19561363Afilalo J, Eisenberg MJ, Morin JF, Bergman H, Monette J, Noiseux N, Perrault LP, Alexander KP, Langlois Y, Dendukuri N, Chamoun P, Kasparian G, Robichaud S, Gharacholou SM, Boivin JF. Gait speed as an incremental predictor of mortality and major morbidity in elderly patients undergoing cardiac surgery. J Am Coll Cardiol. 2010 Nov 9;56(20):1668-76. doi: 10.1016/j.jacc.2010.06.039.
PubMed 21050978Gofus J, Vobornik M, Koblizek V, Pojar M, Vojacek J. The outcome of a preoperative one-minute sit-to-stand test is associated with ventilation time after cardiac surgery. Scand Cardiovasc J. 2021 Jun;55(3):187-193. doi: 10.1080/14017431.2020.1866771. Epub 2020 Dec 26.
PubMed 33356620Afilalo J, Lauck S, Kim DH, Lefevre T, Piazza N, Lachapelle K, Martucci G, Lamy A, Labinaz M, Peterson MD, Arora RC, Noiseux N, Rassi A, Palacios IF, Genereux P, Lindman BR, Asgar AW, Kim CA, Trnkus A, Morais JA, Langlois Y, Rudski LG, Morin JF, Popma JJ, Webb JG, Perrault LP. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol. 2017 Aug 8;70(6):689-700. doi: 10.1016/j.jacc.2017.06.024. Epub 2017 Jul 7.
PubMed 28693934Abdullahi YS, Salmasi MY, Moscarelli M, Parlanti A, Marotta M, Varone E, Solinas M, Sheriff RM, Casula RP, Athanasiou T. The Use of Frailty Scoring to Predict Early Physical Activity Levels After Cardiac Surgery. Ann Thorac Surg. 2021 Jan;111(1):36-43. doi: 10.1016/j.athoracsur.2020.06.029. Epub 2020 Aug 18.
PubMed 32818541Cook DJ, Thompson JE, Prinsen SK, Dearani JA, Deschamps C. Functional recovery in the elderly after major surgery: assessment of mobility recovery using wireless technology. Ann Thorac Surg. 2013 Sep;96(3):1057-61. doi: 10.1016/j.athoracsur.2013.05.092.
PubMed 23992697Joshi A, Mancini R, Probst S, Abikhzer G, Langlois Y, Morin JF, Rudski LG, Afilalo J. Sarcopenia in cardiac surgery: Dual X-ray absorptiometry study from the McGill frailty registry. Am Heart J. 2021 Sep;239:52-58. doi: 10.1016/j.ahj.2021.04.008. Epub 2021 May 4.
PubMed 33957101Hosler QP, Maltagliati AJ, Shi SM, Afilalo J, Popma JJ, Khabbaz KR, Laham RJ, Guibone K, Kim DH. A Practical Two-Stage Frailty Assessment for Older Adults Undergoing Aortic Valve Replacement. J Am Geriatr Soc. 2019 Oct;67(10):2031-2037. doi: 10.1111/jgs.16036. Epub 2019 Jun 18.
PubMed 31211413
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Performance Testing and Frailty in Prediction of Early Postoperative Course After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05166863
- Acronym / sponsor ID
- Cardiostep / 202010 P07
- Conditions
- Cardiac Surgery, Rehabilitation, Frailty, Physical Performance
- Keywords
- surgery, rehabilitation, frailty, performance, activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jan Gofus, MD, PhDUniversity, hospital or other
- Collaborators
- Charles University, Czech Republic
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 22 Dec 2021 (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.
Standard risk prediction models in cardiac surgery (such as EuroSCORE II or STS score) are designed to analyze solely the risk of short-term postoperative mortality. The postoperative morbidity, the ability to rehabilitate or the mid-term survival are not addressed by these means. Recently there have been some reports that addition of physical performance testing to the standard prediction models may provide prognostic value. There is a wide scale of various physical performance and frailty tests that could be used for this purpose, but they have not been confronted with each other yet. Moreover, the postoperative physical rehabilitation has not been objectively assessed in larger scale despite the significant improvement in technology.
The hypothesisis of the study is that the preoperative outcomes of physical performance and frailty testing are able to predict the patient's reconvalescence after cardiac surgery in the short- and mid-term postoperatively. The aim is to analyze a set of tests with regard to their ability to predict postoperative reconvalescence, including the objective activity assessment (using Actigraph wGT3X-BT activity tracking device). Secondarily, the investigators aim to follow the patients up to 1 year postoperatively in terms of evaluating their mid-term outcomes.
Detailed description
Detailed description of testing performed in the exact order as in the patient:
- Body weight and body composition (weigth of fat, weigth of muscle) measurement using bioimpendance scale Tanita BC 545N.
- Katz Index of Independence in Activites of Daily Living performed and assessed exactly as described elsewhere.
- Hand-grip strength test using the Kern MAP 80K1 device. Modified Southhampton protocol will be used for the measurement: Patient is sitting on a chair without side arms, the elbows are in a right angle. The patient is instructed to squeeze the device as much as possible and hold for 3 seconds. He squeezes the device with the right hand, then with the left hand. This is performed two times with each hand in total. The highest measured value is recorded.
- 5-meter gait test. Patient is instructed to walk the 5-meter line as fast as possible and the time is being measured. This is repeated three times. Average time of the three attempts is recorded.
- 6-minute walk test. Patient is instructed to walk without interruption for 6 minutes in the corridor of department's standard ward (exactly 36 meters long). He walks there and back repeatedly and the walked distance is calculated with regard to the number of corridors walked.
- During the last two tests patient is wearing a pulse oxymeter (Berry BM1000C) that is connected with investigator's smartphone (either Android or iOS) through bluetooth. Eventual latent respiratory failure is recorded, defined as a drop in peripheral saturation of 4 % and more, or under 88 %.
- Pre-defined set of laboratory blood tests: haemoglobin, creatinin, albumin, TSH, free T3, free T4.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for non-complex elective cardiac surgery at a single tertiary care cardiovascular center in the Czech Republic.
Key inclusion criteria (3 listed)
- informed patient consent
- patient scheduled for an elective cardiac surgery. The following procedures are accepted: coronary artery bypass grafting (CABG) , single valve replacement (SVR), CABG + SVR, CABG + MAZE procedure, SVR + MAZE procedure
- since June 2021, patients undergoing double-valve surgery have been allowed to be included in the study to promote patients inclusion
Key exclusion criteria (8 listed)
- complex cardiac surgery (except the options listed above)
- ejection fraction of the left ventricle < 30 % according to the last preoperative echocardiography
- EuroSCORE II value > 5 %
- urgent or emergent surgery
- patient unable to walk and/or perform the test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Standard postoperative measures of patient reconvalescence
Time frame: Usually up to 30 days postoperatively
To analyze the ability of preoperative physical performance and frailty tests to predict the standard postoperative measures of patient reconvalescence: length of artificial ventilation, length of stay in the intensive care unit, total postoperative hospital stay.
Objective postoperative patient activity tracking
Time frame: First 4 postoperative days in the standard ward
To analyze the ability of preoperative physical performance and frailty tests to predict the outcomes of objective postoperative patient activity tracking by the means of total number of steps taken during the first 4 days in the standard ward and total intensity of physical activity in this time period, both measured by the dedicated wearable Actigraph activity monitor.
2 secondary outcomes
The dynamics of physical performance in the mid-term postoperatively
Time frame: 1 year postoperatively
Mid-term postoperative mortality, major adverse events, cardiac rehospitalizations
Time frame: 1 year postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 19561363de Arenaza DP, Pepper J, Lees B, Rubinstein F, Nugara F, Roughton M, Jasinski M, Bazzino O, Flather M; ASSERT (Aortic Stentless versus Stented valve assessed by Echocardiography Randomised Trial) Investigators. Preoperative 6-minute walk test adds prognostic information to Euroscore in patients undergoing aortic valve replacement. Heart. 2010 Jan;96(2):113-7. doi: 10.1136/hrt.2008.161174. Epub 2009 Jun 28.
- Background: PubMed 21050978Afilalo J, Eisenberg MJ, Morin JF, Bergman H, Monette J, Noiseux N, Perrault LP, Alexander KP, Langlois Y, Dendukuri N, Chamoun P, Kasparian G, Robichaud S, Gharacholou SM, Boivin JF. Gait speed as an incremental predictor of mortality and major morbidity in elderly patients undergoing cardiac surgery. J Am Coll Cardiol. 2010 Nov 9;56(20):1668-76. doi: 10.1016/j.jacc.2010.06.039.
- Background: PubMed 33356620Gofus J, Vobornik M, Koblizek V, Pojar M, Vojacek J. The outcome of a preoperative one-minute sit-to-stand test is associated with ventilation time after cardiac surgery. Scand Cardiovasc J. 2021 Jun;55(3):187-193. doi: 10.1080/14017431.2020.1866771. Epub 2020 Dec 26.
- Background: PubMed 28693934Afilalo J, Lauck S, Kim DH, Lefevre T, Piazza N, Lachapelle K, Martucci G, Lamy A, Labinaz M, Peterson MD, Arora RC, Noiseux N, Rassi A, Palacios IF, Genereux P, Lindman BR, Asgar AW, Kim CA, Trnkus A, Morais JA, Langlois Y, Rudski LG, Morin JF, Popma JJ, Webb JG, Perrault LP. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol. 2017 Aug 8;70(6):689-700. doi: 10.1016/j.jacc.2017.06.024. Epub 2017 Jul 7.
- Background: PubMed 32818541Abdullahi YS, Salmasi MY, Moscarelli M, Parlanti A, Marotta M, Varone E, Solinas M, Sheriff RM, Casula RP, Athanasiou T. The Use of Frailty Scoring to Predict Early Physical Activity Levels After Cardiac Surgery. Ann Thorac Surg. 2021 Jan;111(1):36-43. doi: 10.1016/j.athoracsur.2020.06.029. Epub 2020 Aug 18.
- Background: PubMed 23992697Cook DJ, Thompson JE, Prinsen SK, Dearani JA, Deschamps C. Functional recovery in the elderly after major surgery: assessment of mobility recovery using wireless technology. Ann Thorac Surg. 2013 Sep;96(3):1057-61. doi: 10.1016/j.athoracsur.2013.05.092.
- Background: PubMed 33957101Joshi A, Mancini R, Probst S, Abikhzer G, Langlois Y, Morin JF, Rudski LG, Afilalo J. Sarcopenia in cardiac surgery: Dual X-ray absorptiometry study from the McGill frailty registry. Am Heart J. 2021 Sep;239:52-58. doi: 10.1016/j.ahj.2021.04.008. Epub 2021 May 4.
- Background: PubMed 31211413Hosler QP, Maltagliati AJ, Shi SM, Afilalo J, Popma JJ, Khabbaz KR, Laham RJ, Guibone K, Kim DH. A Practical Two-Stage Frailty Assessment for Older Adults Undergoing Aortic Valve Replacement. J Am Geriatr Soc. 2019 Oct;67(10):2031-2037. doi: 10.1111/jgs.16036. Epub 2019 Jun 18.
- Individual participant dataSharing planned: Undecided. The anonymized individual patient data will be shared upon a reasonable request to the principal study investigator.
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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.
Ján Gofus, MD, PhD principal investigator
University Hospital Hradec Králové
Jan Vojáček, Professor, MD, PhD study chair
University Hospital Hradec Králové
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Rehabilitation, run by Jan Gofus, MD, PhD at 1 site in Czechia.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 May 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 Czechia. 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?
Results are not available in the source record.
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?
Standard postoperative measures of patient reconvalescence (time frame: Usually up to 30 days postoperatively). The study lists 2 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 NCT05166863, which also lists 8 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 8 May 2024.