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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT04140331

Collaborator

(none)

280

Enrollment

Location

42.7

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases	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 Design

Study Type:

Observational

Anticipated Enrollment :

280 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 9, 2020

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Total energy expenditure evaluated over a 7 days (steps/day) [Day: 7]
Measured by accelerometry.
Low activity time in hours per week (hours/week) [Day: 7]
Measured by accelerometry.
Moderate activity time in hours per week (hours/week) [Day: 7]
Measured by accelerometry.
Intense activity time in hours per week (hours/week) [Day: 7]
Measured by accelerometry.
Time of very intense activity in hours per week (hours/week) [Day: 7]
Measured by accelerometry.
Sleep time in hours per week (hours/week) [Day: 7]
Measured by accelerometry.
Analysis of questionary Duke Activity Status Index (DASI) over a period of 7 days [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 [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) [Day: 7]
Measured by blood sample.
Dosage of prealbumin (g/L) [Day: 7]
Measured by blood sample.
Preoperative strength assessed by dynamometry (Kg) [Day: 14]
Measured by Hand Grip test.
Relationship between preoperative physical activity and duration of stay in intensive care [Months: 26]
Correlation between preoperative physical activity and duration of stay in intensive care.
Preoperative clinical outcome and duration of stay in intensive care [Months: 26]
Correlation between preoperative clinical outcome and duration of stay in intensive care.
Postoperative clinical outcome and duration of stay in intensive care [Months: 26]
Correlation between postoperative clinical outcome and duration of stay in intensive care.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)