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

Terminated

• Conditions: Heart Diseases
• Interventions: Device: Accelerometer

• Registration Number: NCT04140331
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-25
• Study Start: 2020-01-09
• Primary Completion: 2024-04-02
• Status Verified: 2024-06
• Study Completion: 2024-06-04
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 202

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
complicated post-operative evolution	Accelerometer	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	Accelerometer	Patients with a postoperative intensive care unity length of stay \< 5 days after elective cardiac surgery. They will have an accelerometer.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time of very intense activity in hours per week (hours/week)	Day: 7	Measured by accelerometry.
Postoperative clinical outcome and duration of stay in intensive care	Months: 26	Correlation between postoperative clinical outcome and duration of stay in intensive care.
Low activity time 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 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.
Total energy expenditure evaluated over a 7 days (steps/day)	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.
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.
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.
Preoperative clinical outcome and duration of stay in intensive care	Months: 26	Correlation between preoperative clinical outcome and duration of stay in intensive care.
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.

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-Étienne, France