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

NCT ID: NCT04140331

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 202 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-09
• Study Completion Date: 2024-06-04

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.

Conditions

Heart Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Accelerometer

Intervention Type: DEVICE

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.

Accelerometer

Intervention Type: DEVICE

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

Interventions

Accelerometer

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Charles PALAO, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2019-A00525-52

Identifier Type: OTHER

Identifier Source: secondary_id

19CH049

Identifier Type: -

Identifier Source: org_study_id