An observational study in Cardiac Surgery, Rehabilitation and Frailty, sponsored by Jan Gofus, MD, PhD. Active, not recruiting at 1 site in Czechia. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Jan Gofus, MD, PhD · Observational
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 of testing performed in the exact order as in the patient:
1,200 studies on the registry are indexed under Frailty; 429 are open to participants now.
This study's enrollment of 200 is below the median of 223 across 496 observational studies indexed under Frailty.
Browse Frailty studies →This is the only study on the registry with Jan Gofus, MD, PhD as lead sponsor.
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Patients scheduled for non-complex elective cardiac surgery at a single tertiary care cardiovascular center in the Czech Republic.
Exclusion Criteria:
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.
Time frame: 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.
Time frame: First 4 postoperative days in the standard ward
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.
Time frame: 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.
Time frame: 1 year postoperatively
Plan to share: Undecided — The anonymized individual patient data will be shared upon a reasonable request to the principal study investigator.
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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