Level of Accelerometer-assessed Preoperative Physical Activity and Short Term Outcome After Elective Cardiac Surgery

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2024

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.

Interventions

  • Device: Accelerometer
    • Patient will wear the accelerometer for 7 consecutive days to measure the level of physical activity.

Arms, Groups and Cohorts

  • complicated post-operative evolution
    • Patients with a postoperative intensive care unity length of stay ≥ 5 days after elective cardiac surgery. They will have an accelerometer.
  • simple post-operative evolution
    • Patients with a postoperative intensive care unity length of stay < 5 days after elective cardiac surgery. They will have an accelerometer.

Clinical Trial Outcome Measures

Primary Measures

  • Mean daily preoperative walking activity (average of steps/day over a period of 7 days)
    • Time Frame: Day: 7
    • Measured by accelerometry.

Secondary Measures

  • Total energy expenditure evaluated over a 7 days (steps/day)
    • Time Frame: Day: 7
    • Measured by accelerometry.
  • Low activity time in hours per week (hours/week)
    • Time Frame: Day: 7
    • Measured by accelerometry.
  • Moderate activity time in hours per week (hours/week)
    • Time Frame: Day: 7
    • Measured by accelerometry.
  • Intense activity time in hours per week (hours/week)
    • Time Frame: Day: 7
    • Measured by accelerometry.
  • Time of very intense activity in hours per week (hours/week)
    • Time Frame: Day: 7
    • Measured by accelerometry.
  • Sleep time in hours per week (hours/week)
    • Time Frame: Day: 7
    • Measured by accelerometry.
  • Analysis of questionary Duke Activity Status Index (DASI) over a period of 7 days
    • Time Frame: Day: 7
    • Questionary Duke Activity Status Index (DASI) estimates the maximum volume of oxygen used in one minute (VO2 Max) as well as its effort capacity in metabolic equivalent. It contains 11 items. The higher the score indicates better functional capacity.
  • Analysis of questionary Short Nutritional Assessment Questionnaire (SNAQ) over a period of 7 days
    • Time Frame: Day: 7
    • Questionary Short Nutritional Assessment Questionnaire (SNAQ) evaluates nutritional status. The higher the score indicates an important nutritional support.
  • Dosage of albumin (g/L)
    • Time Frame: Day: 7
    • Measured by blood sample.
  • Dosage of prealbumin (g/L)
    • Time Frame: Day: 7
    • Measured by blood sample.
  • Preoperative strength assessed by dynamometry (Kg)
    • Time Frame: Day: 14
    • Measured by Hand Grip test.
  • Relationship between preoperative physical activity and duration of stay in intensive care
    • Time Frame: Months: 26
    • Correlation between preoperative physical activity and duration of stay in intensive care.
  • Preoperative clinical outcome and duration of stay in intensive care
    • Time Frame: Months: 26
    • Correlation between preoperative clinical outcome and duration of stay in intensive care.
  • Postoperative clinical outcome and duration of stay in intensive care
    • Time Frame: Months: 26
    • Correlation between postoperative clinical outcome and duration of stay in intensive care.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Saint Etienne
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Charles PALAO, MD, Principal Investigator, CHU SAINT-ETIENNE
  • Overall Contact(s)
    • Jean-Charles PALAO, MD, (0)477828555, j.charles.palao@chu-st-etienne.fr

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