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Clinical Trials/NCT04140331
NCT04140331
Terminated
Not Applicable

Level of Accelerometer-assessed Preoperative Physical Activity and Short Term Outcome After Elective Cardiac Surgery. A Monocentric Prospective Observational Cohort Study

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country202 target enrollmentJanuary 9, 2020
ConditionsHeart Diseases

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Diseases
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
202
Locations
1
Primary Endpoint
Mean daily preoperative walking activity (average of steps/day over a period of 7 days)
Status
Terminated
Last Updated
last year

Overview

Brief Summary

Short term morbidity after elective cardiac surgery remains significant. Standard predictive models, considering simple patient demographics and clinical parameters, show limited efficiency in individual operative risk assessment. There is growing evidence about daily physical activity as a relevant indicator of preoperative "frailty". Although cardiopulmonary exercise testing remains a gold standard, we are looking for more simple tools in order to identify patients with poor physical condition. Accelerometry may be an objective and reproductible method to measure physical activity at patient's home.

Detailed Description

The aim of this study is to compare accelerometer-assessed preoperative physical activity between two groups of patients with different postoperative length of stay following elective cardiac surgery. In the future, accelerometry could be used to identify patients that may benefit from prehabilitation programs including exercise therapy before elective cardiac surgery.

Registry
clinicaltrials.gov
Start Date
January 9, 2020
End Date
June 4, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Adult subject (≥ 60 years) awaiting elective cardiac surgery
  • Patients affiliated or entitled to a social security scheme
  • Patients who have received information about the study and have given their oral consent to participate

Exclusion Criteria

  • Pregnant woman,
  • Major limitations in physical activity for orthopedic or musculoskeletal reasons
  • Patients under judicial protection (curator or guardianship)

Outcomes

Primary Outcomes

Mean daily preoperative walking activity (average of steps/day over a period of 7 days)

Time Frame: Day: 7

Measured by accelerometry.

Secondary Outcomes

  • Time of very intense activity in hours per week (hours/week)(Day: 7)
  • Postoperative clinical outcome and duration of stay in intensive care(Months: 26)
  • Low activity time in hours per week (hours/week)(Day: 7)
  • Sleep time in hours per week (hours/week)(Day: 7)
  • Analysis of questionary Short Nutritional Assessment Questionnaire (SNAQ) over a period of 7 days(Day: 7)
  • Total energy expenditure evaluated over a 7 days (steps/day)(Day: 7)
  • Moderate activity time in hours per week (hours/week)(Day: 7)
  • Intense activity time in hours per week (hours/week)(Day: 7)
  • Analysis of questionary Duke Activity Status Index (DASI) over a period of 7 days(Day: 7)
  • Dosage of albumin (g/L)(Day: 7)
  • Dosage of prealbumin (g/L)(Day: 7)
  • Preoperative strength assessed by dynamometry (Kg)(Day: 14)
  • Preoperative clinical outcome and duration of stay in intensive care(Months: 26)
  • Relationship between preoperative physical activity and duration of stay in intensive care(Months: 26)

Study Sites (1)

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