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

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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Diseases
• Intervention / Treatment: Device: Accelerometer

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.

• Study Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • Chu Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subject (≥ 60 years) awaiting elective cardiac surgery will be included.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Accelerometer; Patient will wear the accelerometer for 7 consecutive days to measure the level of physical activity.
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.	Device: Accelerometer; Patient will wear the accelerometer for 7 consecutive days to measure the level of physical activity.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total energy expenditure evaluated over a 7 days (steps/day)	Measured by accelerometry.	Day: 7
Low activity time in hours per week (hours/week)	Measured by accelerometry.	Day: 7
Moderate activity time in hours per week (hours/week)	Measured by accelerometry.	Day: 7
Intense activity time in hours per week (hours/week)	Measured by accelerometry.	Day: 7
Time of very intense activity in hours per week (hours/week)	Measured by accelerometry.	Day: 7
Sleep time in hours per week (hours/week)	Measured by accelerometry.	Day: 7
Analysis of questionary Duke Activity Status Index (DASI) over a period of 7 days	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.	Day: 7
Analysis of questionary Short Nutritional Assessment Questionnaire (SNAQ) over a period of 7 days	Questionary Short Nutritional Assessment Questionnaire (SNAQ) evaluates nutritional status. The higher the score indicates an important nutritional support.	Day: 7
Dosage of albumin (g/L)	Measured by blood sample.	Day: 7
Dosage of prealbumin (g/L)	Measured by blood sample.	Day: 7
Preoperative strength assessed by dynamometry (Kg)	Measured by Hand Grip test.	Day: 14
Relationship between preoperative physical activity and duration of stay in intensive care	Correlation between preoperative physical activity and duration of stay in intensive care.	Months: 26
Preoperative clinical outcome and duration of stay in intensive care	Correlation between preoperative clinical outcome and duration of stay in intensive care.	Months: 26
Postoperative clinical outcome and duration of stay in intensive care	Correlation between postoperative clinical outcome and duration of stay in intensive care.	Months: 26

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Jean-Charles PALAO, MD, Chu Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): April 2, 2024
• Study Completion (Actual): June 4, 2024

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Accelerometry; Cardiac surgery; Accelerometer; Post-operative evolution; Preoperative physical activity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 19CH049; 2019-A00525-52 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No