University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
NCT Number: NCT03328039
This is an observational, non-interventional study to assess the equivalence of wearable monitors with formal CPET testing for the prediction of physiological reserve before major surgery.
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Notify Me18 year–100 year
All sexes
Observational
Cardiff, CF14 4XW, United Kingdom
This project will exploit the rapid development of wearable technology to allow perioperative risk prediction to become logistically easier, cost effective and used more broadly. It will use low cost wearable technology to complement or act as a surrogate to complex CPET testing performed for perioperative risk stratification. The data gained from a Garmin Vivosmart HR+ wearable device, will be used in the community by patients awaiting surgery, and will be correlated with key CPET indices including anaerobic threshold and peak VO2. Ultimately, this study aims to assess whether wearable technology can provide the data needed for the formation of prediction models to risk assess perioperative outcomes in patients undergoing high-risk elective surgery. In addition, an International Physical Activity Questionnaire (IPAQ) will be completed to compare the activity captured with self-reported activity. This will be combined with frailty scores and handgrip strength as is routinely collected during CPET. Finally, a saliva based genetic analysis will be conducted on genetic variations known to be of significance in critical illness and response to physical stress. This will be delivered by a laboratory (Fitness Genes) that has developed a bespoke panel of genetic markers ideally suited to this patient cohort.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Physiological data capture only
Time frame: 7 days
Successful recoding of accelerometer data
Cardiff University
Other
Acronym: STEPS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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