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

Heart Diseases Clinical Trial

— ACTI-CARD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04140331
• Other study ID #: 19CH049
• Secondary ID: 2019-A00525-52
• Status: Terminated
• Start date: January 9, 2020
• Est. completion date: June 4, 2024

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 202
• Est. completion date: June 4, 2024
• Est. primary completion date: April 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean daily preoperative walking activity (average of steps/day over a period of 7 days)	Measured by accelerometry.	Day: 7
Secondary	Total energy expenditure evaluated over a 7 days (steps/day)	Measured by accelerometry.	Day: 7
Secondary	Low activity time in hours per week (hours/week)	Measured by accelerometry.	Day: 7
Secondary	Moderate activity time in hours per week (hours/week)	Measured by accelerometry.	Day: 7
Secondary	Intense activity time in hours per week (hours/week)	Measured by accelerometry.	Day: 7
Secondary	Time of very intense activity in hours per week (hours/week)	Measured by accelerometry.	Day: 7
Secondary	Sleep time in hours per week (hours/week)	Measured by accelerometry.	Day: 7
Secondary	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
Secondary	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
Secondary	Dosage of albumin (g/L)	Measured by blood sample.	Day: 7
Secondary	Dosage of prealbumin (g/L)	Measured by blood sample.	Day: 7
Secondary	Preoperative strength assessed by dynamometry (Kg)	Measured by Hand Grip test.	Day: 14
Secondary	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
Secondary	Preoperative clinical outcome and duration of stay in intensive care	Correlation between preoperative clinical outcome and duration of stay in intensive care.	Months: 26
Secondary	Postoperative clinical outcome and duration of stay in intensive care	Correlation between postoperative clinical outcome and duration of stay in intensive care.	Months: 26