Clinical trial NCT04140331: Level of Accelerometer-assessed Preoperative Physical Activity and Short Term Outcome After Elective Cardiac Surgery
Official title: Level of Accelerometer-assessed Preoperative Physical Activity and Short Term Outcome After Elective Cardiac Surgery. A Monocentric Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Diseases
Keywords: Post-operative evolution
Accelerometer
Cardiac surgery
Accelerometry
Preoperative physical activity
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 202
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subject (≥ 60 years) awaiting elective cardiac surgery will be included.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Mean daily preoperative walking activity (average of steps/day over a period of 7 days)
timeFrame: Day: 7
Secondary outcomes:
measure: Total energy expenditure evaluated over a 7 days (steps/day)
timeFrame: Day: 7
measure: Low activity time in hours per week (hours/week)
timeFrame: Day: 7
measure: Moderate activity time in hours per week (hours/week)
timeFrame: Day: 7
measure: Intense activity time in hours per week (hours/week)
timeFrame: Day: 7
measure: Time of very intense activity in hours per week (hours/week)
timeFrame: Day: 7
measure: Sleep time in hours per week (hours/week)
timeFrame: Day: 7
measure: Analysis of questionary Duke Activity Status Index (DASI) over a period of 7 days
timeFrame: Day: 7
measure: Analysis of questionary Short Nutritional Assessment Questionnaire (SNAQ) over a period of 7 days
timeFrame: Day: 7
measure: Dosage of albumin (g/L)
timeFrame: Day: 7
measure: Dosage of prealbumin (g/L)
timeFrame: Day: 7
measure: Preoperative strength assessed by dynamometry (Kg)
timeFrame: Day: 14
measure: Relationship between preoperative physical activity and duration of stay in intensive care
timeFrame: Months: 26
measure: Preoperative clinical outcome and duration of stay in intensive care
timeFrame: Months: 26
measure: Postoperative clinical outcome and duration of stay in intensive care
timeFrame: Months: 26
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Jean-Charles PALAO, MD
role: PRINCIPAL_INVESTIGATOR
References: