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

NCT04140331 | Terminated

• 2 other identifiers: 19CH0492019-A00525-52
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases

Keywords

Post-operative evolution; Accelerometer; Cardiac surgery; Accelerometry; Preoperative physical activity

Outcome Measures

Primary Outcomes (1)

• Mean daily preoperative walking activity (average of steps/day over a period of 7 days)

  Measured by accelerometry.

  Day: 7

Secondary Outcomes (14)

• Total energy expenditure evaluated over a 7 days (steps/day)

  Day: 7

• Low activity time in hours per week (hours/week)

  Day: 7

• Moderate activity time in hours per week (hours/week)

  Day: 7

• Intense activity time in hours per week (hours/week)

  Day: 7

• Time of very intense activity in hours per week (hours/week)

  Day: 7

Study Arms (2)

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

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

Interventions

Accelerometer DEVICE

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

complicated post-operative evolution; simple post-operative evolution

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subject (≥ 60 years) awaiting elective cardiac surgery will be included.

You may qualify if:

• 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

You may not qualify if:

• Pregnant woman,
• Major limitations in physical activity for orthopedic or musculoskeletal reasons
• Patients under judicial protection (curator or guardianship)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Jean-Charles PALAO, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 25, 2019
• Study Start: January 9, 2020
• Primary Completion: April 2, 2024
• Study Completion: June 4, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)