Perioperative/Postoperative ComplicationsSHAPEPATNCT05743673
SHAPE Test for Preoperative Risk Stratification
An observational study of Perioperative/Postoperative Complications and Aerobic Capacity, run by Yale University at 1 site in United States.
Trial summary
This study is looking at whether a simplified exercise test called the SHAPE-HF cardiopulmonary testing system can be used before surgery in older adults. Doctors often need to know how well a patient's heart, lungs, and body handle physical activity before moderate- to high-risk surgery. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perioperative/Postoperative Complications, Aerobic Capacity
- What is being tested?
- Shape II
- Type of treatment
- Medical device
- How many people
- 371 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2023to 29 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The overall goal is the development of a validation cohort of older adults, defined as >60 years old, self-reporting >4 METS and with a score of <2 on the revised cardiac risk index (RCRI)1
Who may be able to join
- Aged >60 years
- Scheduled for pre-surgical evaluation for moderate to high-risk surgical procedure.
- RCRI <2 based on screening of preoperative co-morbidities.
- Provision of signed and dated informed consent form
Who cannot join
- Age <60 years old
- Subjective METS <4
- Inability to give independent informed consent
- Revised Cardiac Risk Index (RCRI) >2
- Neurological impairment with motor limitations
- Mental impairment leading to inability to cooperate
Show all 21Show fewer
- Recent NSTEMI or STEMI type myocardial infarction (within 6 months)
- Angina (stable or unstable, within 6 months)
- Uncorrected severe valvular heart disease (severe aortic, tricuspid, or mitral stenosis)
- Recent exacerbation of congestive heart failure (requiring hospitalization, within 6 months)
- Acute pulmonary embolism or deep vein thrombosis (within past 6 months)
- Uncontrolled pulmonary edema
- Uncontrolled symptomatic arrhythmias
- Active endocarditis
- Acute myocarditis or pericarditis
- Active wheezing or home oxygen use
- Recent exacerbation of chronic obstructive pulmonary disease or asthma or pneumonia (requiring hospitalization, within 6 months)
- Inability to perform components of the SHAPE test (severe hip flexion limitation, severe osteoarthritis of knee or hip, limb immobilization, ambulation with a walker, can or crutches, baseline balance irregularities
- Diagnosis of vertigo
- Known allergic reactions to components of the SHAPE medical system apparatus disposable mouthpiece.
- Active enrollment in an interventional clinical trial within the enrollment period of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: A Feasibility Study of the SHAPE™ Test of Aerobic Fitness in Older Adults Presenting for Moderate to High-risk Surgery
This study is looking at whether a simplified exercise test called the SHAPE-HF cardiopulmonary testing system can be used before surgery in older adults. Doctors often need to know how well a patient's heart, lungs, and body handle physical activity before moderate- to high-risk surgery. This information may help them better understand a patient's fitness for surgery and possible risk of complications afterward.
The study will enroll adults older than 60 years who are being evaluated before planned moderate- to high-risk noncardiac surgery. The first goal is to determine if this was feasible in older adults and to learn whether patients can be successfully recruited to complete this pre-surgery test. Secondly, the study will also look at how results from the SHAPE-HF system compare with common ways doctors now estimate fitness, such as asking patients about their physical activity and using a standard questionnaire.
Read more
Participants will attend one in-person study visit lasting about 35 minutes. During that visit, they will answer questions about their activity level and complete testing with the SHAPE-HF system. The test uses short periods of lower-intensity exercise to estimate aerobic fitness. After the visit, participants will be contacted by phone about 24 hours later to check for any problems related to the study test.
Lastly, researchers will also review information from the medical record for 30 days after surgery to see whether test results are related to recovery, short-term health problems after surgery, or major complications. No extra surgery or change in planned medical care is part of this study. The information learned may help improve how doctors evaluate older adults before surgery in the future.
Read the detailed description
Preoperative functional capacity is a central component of perioperative risk assessment in older adults undergoing moderate- to high-risk surgery. Reduced cardiopulmonary reserve is associated with increased postoperative morbidity, prolonged recovery, and major adverse cardiovascular events, yet functional capacity in routine practice is often estimated using subjective measures such as self-reported activity tolerance, MET estimates, and questionnaire-based assessment. These tools are practical but may misclassify physiologic fitness, particularly in older adults who report acceptable activity levels despite diminished aerobic reserve.
Objective cardiopulmonary exercise testing can provide more precise assessment, but widespread use is limited by the complexity and burden of conventional testing. The SHAPE-HF cardiopulmonary testing system is an FDA-approved simplified submaximal exercise testing platform intended to provide objective assessment of aerobic fitness in a manner that may be more feasible for routine use in a preoperative clinic.
Conventional cardiopulmonary exercise testing can provide objective assessment of aerobic capacity, but broad implementation is often limited by time, workflow, equipment, and patient burden. The SHAPE-HF cardiopulmonary testing system is an FDA-approved simplified submaximal cardiopulmonary exercise testing platform designed to generate objective physiologic measures of aerobic fitness using abbreviated exercise testing. This approach may offer a more practical method for assessing functional capacity in a high-volume preoperative clinic while reducing the burden associated with traditional maximal exercise testing.
This study is a prospective, single-site, non-randomized investigation evaluating the use of the SHAPE-HF cardiopulmonary testing system in adults older than 60 years who are undergoing preoperative evaluation before moderate- to high-risk surgery. The study population includes patients with a Revised Cardiac Risk Index (RCRI) score less than 4 and self-reported functional capacity greater than 4 METs who otherwise meet protocol-defined eligibility criteria. This population was selected because many such patients would typically be considered to have acceptable functional status by standard preoperative screening, yet some may still have unrecognized limitations in aerobic capacity and increased perioperative risk.
The study has been modified over time to support progressively broader scientific aims. It was initially conducted as a technical proof-of-concept study enrolling 42 participants to evaluate implementation of simplified submaximal cardiopulmonary exercise testing in the preoperative setting. The protocol was subsequently modified to a feasibility study with a planned enrollment of 101 participants to evaluate recruitment, workflow integration, and practical use of the SHAPE-HF system in an older surgical population. The study has now been further expanded to a total planned enrollment of 371 participants in order to better evaluate perioperative complications and the relationship between submaximal cardiopulmonary exercise testing performance and postoperative outcomes, and to provide adequate statistical power to identify associations with major adverse perioperative events.
Participants complete a single in-person study visit of approximately 35 minutes during the preoperative period. During this visit, conventional preoperative functional assessments are obtained, including subjective MET assessment and Duke Activity Status Index evaluation, and participants undergo SHAPE-HF submaximal cardiopulmonary exercise testing. A follow-up telephone contact is performed approximately 24 hours after testing to assess for adverse events related to the study procedure. Participants then undergo postoperative follow-up through medical record review for 30 days after surgery.
The primary objectives of the current study are to evaluate the feasibility and operational performance of using the SHAPE-HF cardiopulmonary testing system in a preoperative clinic for older adults undergoing moderate- to high-risk surgery and to assess the relationship between SHAPE-HF-derived performance measures and clinically relevant postoperative outcomes. Study aims include comparison of SHAPE-HF results with conventional measures of functional capacity, including subjective MET assessment and Duke Activity Status Index scores. The study also evaluates whether SHAPE-HF performance variables are associated with short-term postoperative morbidity, as measured by the Postoperative Morbidity Survey, and with major postoperative complications within 30 days of surgery.
Postoperative outcomes of interest include major adverse cardiovascular and other clinically significant perioperative events, including myocardial infarction, stroke, atrial fibrillation, congestive heart failure, pneumonia, hospital readmission, and death. By expanding from proof-of-concept and feasibility phases to a larger powered cohort, the study is intended to determine whether abbreviated submaximal cardiopulmonary exercise testing can improve identification of older surgical patients at elevated perioperative risk beyond conventional subjective assessment alone.
This investigation is not designed to alter the participant's planned surgical treatment or routine perioperative care. Rather, it evaluates whether an abbreviated, objective, and scalable assessment of aerobic fitness can be integrated into preoperative evaluation and whether the resulting physiologic measures may improve perioperative risk stratification in older adults presenting for moderate- to high-risk surgery.
- Being tested
- Shape II
- Keywords
- perioperative risk stratification, submaximal cardiopulmonary exercise testing, postoperative complications, perioperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shape IIDevice
cardiopulmonary exercise testing apparatus
| Study group | Role | What they receive |
|---|---|---|
| Validation Cohort | Older subjects (>60 years old) presenting for moderate to high-risk surgical procedure with reported subjective metabolic equivalents of >4 METS and with a score of <4 on the revised cardiac risk index (RCRI) undergoing submaximal exercise testing. Receives: Device: Shape II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Success
The primary objective for the study is a study enrollment rate of 25% of eligible candidates.
Within the parameters of a feasibility study, the following questions will also be addressed:
- Physical capacity of clinic to handle the number of participants in the study.
- Adequate communication and time frame to efficiently perform abbreviated cardiopulmonary exercise testing in high-volume preoperative testing environment.
- Adequate software and hardware to capture and use data obtained from abbreviated cardiopulmonary exercise testing.
- Determination of adequate institutional, departmental and clinical support to maintain and perform abbreviated cardiopulmonary exercise testing as an adjunct for preoperative testing.
- Does abbreviated cardiopulmonary testing in a preoperative testing environment improve access to care in a diverse and at-risk surgical population
Measured: 0-30 days
Secondary outcomes (3)
Conventional measure of metabolic equivalents (METS)
If conventional measures of METS (subjective METS, Duke Activity Status Index) compare favorably to the SHAPE testing performance variables.
Measured: 0-1 day
Perioperative Morbidity Survey
- If SHAPE™ performance variables predict a higher risk of postoperative morbidity after surgery using the Postoperative Operative Morbidity Survey (POMS), a short-term measure of postoperative morbidity after major elective surgery.
Measured: 0-30 days
Major postoperative outcomes
- If SHAPE™ performance variables predict a higher risk of postoperative major morbidity as measured by traditional major 30-day complications (myocardial infarction, stroke, atrial fibrillation, surgical site infection, postoperative pulmonary complications)
Measured: 0-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start3 May 2023
- Primary completion29 Nov 2026 (estimated)
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Yale 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 371 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zyad Carr, Yale University
- Investigators
- Zyad J Carr, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743673
- Sponsor's protocol ID
- 2000033885
- Acronym
- SHAPEPAT
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Variable description, values and deidentified patient physiological data.
Publications
Ackland GL, Abbott TEF, Minto G, Clark M, Owen T, Prabhu P, May SM, Reynolds JA, Cuthbertson BH, Wijeysundera D, Pearse RM; METS and POM-HR Study Investigators. Heart rate recovery and morbidity after noncardiac surgery: Planned secondary analysis of two prospective, multi-centre, blinded observational studies. PLoS One. 2019 Aug 21;14(8):e0221277. doi: 10.1371/journal.pone.0221277. eCollection 2019.
PubMed 31433825Bennett H, Parfitt G, Davison K, Eston R. Validity of Submaximal Step Tests to Estimate Maximal Oxygen Uptake in Healthy Adults. Sports Med. 2016 May;46(5):737-50. doi: 10.1007/s40279-015-0445-1.
PubMed 26670455Bernstein EJ, Mandl LA, Gordon JK, Spiera RF, Horn EM. Submaximal heart and pulmonary evaluation: a novel noninvasive test to identify pulmonary hypertension in patients with systemic sclerosis. Arthritis Care Res (Hoboken). 2013 Oct;65(10):1713-8. doi: 10.1002/acr.22051.
PubMed 23740875Bohannon RW, Crouch RH. Two-Minute Step Test of Exercise Capacity: Systematic Review of Procedures, Performance, and Clinimetric Properties. J Geriatr Phys Ther. 2019 Apr/Jun;42(2):105-112. doi: 10.1519/JPT.0000000000000164.
PubMed 29210933Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Cole CR, Blackstone EH, Pashkow FJ, Snader CE, Lauer MS. Heart-rate recovery immediately after exercise as a predictor of mortality. N Engl J Med. 1999 Oct 28;341(18):1351-7. doi: 10.1056/NEJM199910283411804.
PubMed 10536127Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ. 2005 Sep 13;173(6):627-34. doi: 10.1503/cmaj.050011.
PubMed 16157727Ferguson M, Shulman M. Cardiopulmonary Exercise Testing and Other Tests of Functional Capacity. Curr Anesthesiol Rep. 2022;12(1):26-33. doi: 10.1007/s40140-021-00499-6. Epub 2021 Nov 20.
PubMed 34840532Gerson MC, Hurst JM, Hertzberg VS, Baughman R, Rouan GW, Ellis K. Prediction of cardiac and pulmonary complications related to elective abdominal and noncardiac thoracic surgery in geriatric patients. Am J Med. 1990 Feb;88(2):101-7. doi: 10.1016/0002-9343(90)90456-n.
PubMed 2301435Grocott MP, Browne JP, Van der Meulen J, Matejowsky C, Mutch M, Hamilton MA, Levett DZ, Emberton M, Haddad FS, Mythen MG. The Postoperative Morbidity Survey was validated and used to describe morbidity after major surgery. J Clin Epidemiol. 2007 Sep;60(9):919-28. doi: 10.1016/j.jclinepi.2006.12.003. Epub 2007 May 7.
PubMed 17689808Hansen D, Jacobs N, Thijs H, Dendale P, Claes N. Validation of a single-stage fixed-rate step test for the prediction of maximal oxygen uptake in healthy adults. Clin Physiol Funct Imaging. 2016 Sep;36(5):401-6. doi: 10.1111/cpf.12243. Epub 2015 Jun 5.
PubMed 26046474Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7.
PubMed 2782256Kallianos A, Rapti A, Tsimpoukis S, Charpidou A, Dannos I, Kainis E, Syrigos K. Cardiopulmonary exercise testing (CPET) as preoperative test before lung resection. In Vivo. 2014 Nov-Dec;28(6):1013-20.
PubMed 25398794Khatri V, Neal JE, Burger CD, Lee AS. Prognostication in Pulmonary Arterial Hypertension with Submaximal Exercise Testing. Diseases. 2015 Feb 6;3(1):15-23. doi: 10.3390/diseases3010015.
PubMed 28943605Carr ZJ. A gas exchange derived pulmonary capacitance to peak oxygen uptake slope threshold did not validate as a marker of early postoperative morbidity. BJA Open. 2026 Jul 20;19:100582. doi: 10.1016/j.bjao.2026.100582. eCollection 2026 Sep.
PubMed 42495006
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of the SHAPE™ Test of Aerobic Fitness in Older Adults Presenting for Moderate to High-risk Surgery
- ClinicalTrials.gov ID
- NCT05743673
- Acronym / sponsor ID
- SHAPEPAT / 2000033885
- Keywords
- perioperative risk stratification, submaximal cardiopulmonary exercise testing, postoperative complications, perioperative complications
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 371 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 29 Nov 2026 (estimated)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 24 Feb 2023 (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.
This study is looking at whether a simplified exercise test called the SHAPE-HF cardiopulmonary testing system can be used before surgery in older adults. Doctors often need to know how well a patient's heart, lungs, and body handle physical activity before moderate- to high-risk surgery. This information may help them better understand a patient's fitness for surgery and possible risk of complications afterward.
The study will enroll adults older than 60 years who are being evaluated before planned moderate- to high-risk noncardiac surgery. The first goal is to determine if this was feasible in older adults and to learn whether patients can be successfully recruited to complete this pre-surgery test. Secondly, the study will also look at how results from the SHAPE-HF system compare with common ways doctors now estimate fitness, such as asking patients about their physical activity and using a standard questionnaire.
Participants will attend one in-person study visit lasting about 35 minutes. During that visit, they will answer questions about their activity level and complete testing with the SHAPE-HF system. The test uses short periods of lower-intensity exercise to estimate aerobic fitness. After the visit, participants will be contacted by phone about 24 hours later to check for any problems related to the study test.
Lastly, researchers will also review information from the medical record for 30 days after surgery to see whether test results are related to recovery, short-term health problems after surgery, or major complications. No extra surgery or change in planned medical care is part of this study. The information learned may help improve how doctors evaluate older adults before surgery in the future.
Detailed description
Preoperative functional capacity is a central component of perioperative risk assessment in older adults undergoing moderate- to high-risk surgery. Reduced cardiopulmonary reserve is associated with increased postoperative morbidity, prolonged recovery, and major adverse cardiovascular events, yet functional capacity in routine practice is often estimated using subjective measures such as self-reported activity tolerance, MET estimates, and questionnaire-based assessment. These tools are practical but may misclassify physiologic fitness, particularly in older adults who report acceptable activity levels despite diminished aerobic reserve.
Objective cardiopulmonary exercise testing can provide more precise assessment, but widespread use is limited by the complexity and burden of conventional testing. The SHAPE-HF cardiopulmonary testing system is an FDA-approved simplified submaximal exercise testing platform intended to provide objective assessment of aerobic fitness in a manner that may be more feasible for routine use in a preoperative clinic.
Conventional cardiopulmonary exercise testing can provide objective assessment of aerobic capacity, but broad implementation is often limited by time, workflow, equipment, and patient burden. The SHAPE-HF cardiopulmonary testing system is an FDA-approved simplified submaximal cardiopulmonary exercise testing platform designed to generate objective physiologic measures of aerobic fitness using abbreviated exercise testing. This approach may offer a more practical method for assessing functional capacity in a high-volume preoperative clinic while reducing the burden associated with traditional maximal exercise testing.
This study is a prospective, single-site, non-randomized investigation evaluating the use of the SHAPE-HF cardiopulmonary testing system in adults older than 60 years who are undergoing preoperative evaluation before moderate- to high-risk surgery. The study population includes patients with a Revised Cardiac Risk Index (RCRI) score less than 4 and self-reported functional capacity greater than 4 METs who otherwise meet protocol-defined eligibility criteria. This population was selected because many such patients would typically be considered to have acceptable functional status by standard preoperative screening, yet some may still have unrecognized limitations in aerobic capacity and increased perioperative risk.
The study has been modified over time to support progressively broader scientific aims. It was initially conducted as a technical proof-of-concept study enrolling 42 participants to evaluate implementation of simplified submaximal cardiopulmonary exercise testing in the preoperative setting. The protocol was subsequently modified to a feasibility study with a planned enrollment of 101 participants to evaluate recruitment, workflow integration, and practical use of the SHAPE-HF system in an older surgical population. The study has now been further expanded to a total planned enrollment of 371 participants in order to better evaluate perioperative complications and the relationship between submaximal cardiopulmonary exercise testing performance and postoperative outcomes, and to provide adequate statistical power to identify associations with major adverse perioperative events.
Participants complete a single in-person study visit of approximately 35 minutes during the preoperative period. During this visit, conventional preoperative functional assessments are obtained, including subjective MET assessment and Duke Activity Status Index evaluation, and participants undergo SHAPE-HF submaximal cardiopulmonary exercise testing. A follow-up telephone contact is performed approximately 24 hours after testing to assess for adverse events related to the study procedure. Participants then undergo postoperative follow-up through medical record review for 30 days after surgery.
The primary objectives of the current study are to evaluate the feasibility and operational performance of using the SHAPE-HF cardiopulmonary testing system in a preoperative clinic for older adults undergoing moderate- to high-risk surgery and to assess the relationship between SHAPE-HF-derived performance measures and clinically relevant postoperative outcomes. Study aims include comparison of SHAPE-HF results with conventional measures of functional capacity, including subjective MET assessment and Duke Activity Status Index scores. The study also evaluates whether SHAPE-HF performance variables are associated with short-term postoperative morbidity, as measured by the Postoperative Morbidity Survey, and with major postoperative complications within 30 days of surgery.
Postoperative outcomes of interest include major adverse cardiovascular and other clinically significant perioperative events, including myocardial infarction, stroke, atrial fibrillation, congestive heart failure, pneumonia, hospital readmission, and death. By expanding from proof-of-concept and feasibility phases to a larger powered cohort, the study is intended to determine whether abbreviated submaximal cardiopulmonary exercise testing can improve identification of older surgical patients at elevated perioperative risk beyond conventional subjective assessment alone.
This investigation is not designed to alter the participant's planned surgical treatment or routine perioperative care. Rather, it evaluates whether an abbreviated, objective, and scalable assessment of aerobic fitness can be integrated into preoperative evaluation and whether the resulting physiologic measures may improve perioperative risk stratification in older adults presenting for moderate- to high-risk surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation Cohort | – | Device: Shape IIOlder subjects (>60 years old) presenting for moderate to high-risk surgical procedure with reported subjective metabolic equivalents of >4 METS and with a score of <4 on the revised cardiac risk index (RCRI) undergoing submaximal exercise testing. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The overall goal is the development of a validation cohort of older adults, defined as >60 years old, self-reporting >4 METS and with a score of <2 on the revised cardiac risk index (RCRI)1
Key inclusion criteria (4 listed)
- Aged >60 years
- Scheduled for pre-surgical evaluation for moderate to high-risk surgical procedure.
- RCRI <2 based on screening of preoperative co-morbidities.
- Provision of signed and dated informed consent form
Key exclusion criteria (21 listed)
- Age <60 years old
- Subjective METS <4
- Inability to give independent informed consent
- Revised Cardiac Risk Index (RCRI) >2
- Neurological impairment with motor limitations
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 |
|---|---|---|
| Shape IIcardiopulmonary exercise testing apparatus | Device | Validation Cohort |
Primary outcome
Recruitment Success
Time frame: 0-30 days
The primary objective for the study is a study enrollment rate of 25% of eligible candidates. Within the parameters of a feasibility study, the following questions will also be addressed: * Physical capacity of clinic to handle the number of participants in the study. * Adequate communication and time frame to efficiently perform abbreviated cardiopulmonary exercise testing in high-volume preoperative testing environment. * Adequate software and hardware to capture and use data obtained from abbreviated cardiopulmonary exercise testing. * Determination of adequate institutional, departmental and clinical support to maintain and perform abbreviated cardiopulmonary exercise testing as an adjunct for preoperative testing. * Does abbreviated cardiopulmonary testing in a preoperative testing environment improve access to care in a diverse and at-risk surgical population
3 secondary outcomes
Conventional measure of metabolic equivalents (METS)
Time frame: 0-1 day
Perioperative Morbidity Survey
Time frame: 0-30 days
Major postoperative outcomes
Time frame: 0-30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 31433825Ackland GL, Abbott TEF, Minto G, Clark M, Owen T, Prabhu P, May SM, Reynolds JA, Cuthbertson BH, Wijeysundera D, Pearse RM; METS and POM-HR Study Investigators. Heart rate recovery and morbidity after noncardiac surgery: Planned secondary analysis of two prospective, multi-centre, blinded observational studies. PLoS One. 2019 Aug 21;14(8):e0221277. doi: 10.1371/journal.pone.0221277. eCollection 2019.
- Background: PubMed 26670455Bennett H, Parfitt G, Davison K, Eston R. Validity of Submaximal Step Tests to Estimate Maximal Oxygen Uptake in Healthy Adults. Sports Med. 2016 May;46(5):737-50. doi: 10.1007/s40279-015-0445-1.
- Background: PubMed 23740875Bernstein EJ, Mandl LA, Gordon JK, Spiera RF, Horn EM. Submaximal heart and pulmonary evaluation: a novel noninvasive test to identify pulmonary hypertension in patients with systemic sclerosis. Arthritis Care Res (Hoboken). 2013 Oct;65(10):1713-8. doi: 10.1002/acr.22051.
- Background: PubMed 29210933Bohannon RW, Crouch RH. Two-Minute Step Test of Exercise Capacity: Systematic Review of Procedures, Performance, and Clinimetric Properties. J Geriatr Phys Ther. 2019 Apr/Jun;42(2):105-112. doi: 10.1519/JPT.0000000000000164.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 10536127Cole CR, Blackstone EH, Pashkow FJ, Snader CE, Lauer MS. Heart-rate recovery immediately after exercise as a predictor of mortality. N Engl J Med. 1999 Oct 28;341(18):1351-7. doi: 10.1056/NEJM199910283411804.
- Background: PubMed 16157727Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ. 2005 Sep 13;173(6):627-34. doi: 10.1503/cmaj.050011.
- Background: PubMed 34840532Ferguson M, Shulman M. Cardiopulmonary Exercise Testing and Other Tests of Functional Capacity. Curr Anesthesiol Rep. 2022;12(1):26-33. doi: 10.1007/s40140-021-00499-6. Epub 2021 Nov 20.
- Background: PubMed 2301435Gerson MC, Hurst JM, Hertzberg VS, Baughman R, Rouan GW, Ellis K. Prediction of cardiac and pulmonary complications related to elective abdominal and noncardiac thoracic surgery in geriatric patients. Am J Med. 1990 Feb;88(2):101-7. doi: 10.1016/0002-9343(90)90456-n.
- Background: PubMed 17689808Grocott MP, Browne JP, Van der Meulen J, Matejowsky C, Mutch M, Hamilton MA, Levett DZ, Emberton M, Haddad FS, Mythen MG. The Postoperative Morbidity Survey was validated and used to describe morbidity after major surgery. J Clin Epidemiol. 2007 Sep;60(9):919-28. doi: 10.1016/j.jclinepi.2006.12.003. Epub 2007 May 7.
- Background: PubMed 26046474Hansen D, Jacobs N, Thijs H, Dendale P, Claes N. Validation of a single-stage fixed-rate step test for the prediction of maximal oxygen uptake in healthy adults. Clin Physiol Funct Imaging. 2016 Sep;36(5):401-6. doi: 10.1111/cpf.12243. Epub 2015 Jun 5.
- Background: PubMed 2782256Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7.
- Individual participant dataSharing planned: Undecided. Variable description, values and deidentified patient physiological data.
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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.
Zyad J Carr, M.D. principal investigator
Yale University
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 Perioperative/Postoperative Complications and Aerobic Capacity, run by Yale University at 1 site in United States.
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 4 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Recruitment Success (time frame: 0-30 days). 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 NCT05743673, which also lists 18 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 19 Oct 2026.