Physical Performance Testing and Frailty in Prediction of Early Postoperative Course After Cardiac Surgery (Cardiostep)

May 7, 2024 updated by: Jan Gofus, MD, PhD

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Detailed description of testing performed in the exact order as in the patient:

  1. Body weight and body composition (weigth of fat, weigth of muscle) measurement using bioimpendance scale Tanita BC 545N.
  2. Katz Index of Independence in Activites of Daily Living performed and assessed exactly as described elsewhere.
  3. 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.
  4. 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.
  5. 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.
  6. 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 %.
  7. Pre-defined set of laboratory blood tests: haemoglobin, creatinin, albumin, TSH, free T3, free T4.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Královehradecký Kraj
      • Hradec Králové, Královehradecký Kraj, Czechia, 500 02
        • University Hospital Hradec Kralove

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for non-complex elective cardiac surgery at a single tertiary care cardiovascular center in the Czech Republic.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Usually up to 30 days postoperatively
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.
First 4 postoperative days in the standard ward

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The dynamics of physical performance in the mid-term postoperatively
Time Frame: 1 year 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.
1 year postoperatively
Mid-term postoperative mortality, major adverse events, cardiac rehospitalizations
Time Frame: 1 year postoperatively
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.
1 year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jan Gofus, MD, PhD

Collaborators

Charles University, Czech Republic

Investigators

  • Principal Investigator: Ján Gofus, MD, PhD, University Hospital Hradec Kralove
  • Study Chair: Jan Vojáček, Professor, MD, PhD, University Hospital Hradec Kralove

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2021

Primary Completion (Actual)

December 30, 2023

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (Actual)

December 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202010 P07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The anonymized individual patient data will be shared upon a reasonable request to the principal study investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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