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TerminatedNCT04140331ACTI-CARDUpdated Jun 18, 2024

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

An observational study in Heart Diseases, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-06-18.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Why this study was terminated
Recruitment difficulties
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
202
Ages
60 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Heart Diseases

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Keywords

  • Post-operative evolution
  • Accelerometer
  • Cardiac surgery
  • Accelerometry
  • Preoperative physical activity
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In context

Heart Diseases

3,640 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 202 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
202 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceAccelerometer

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

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What researchers measure

Primary outcomes

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

    Measured by accelerometry.

    Time frame: Day: 7

Secondary outcomes

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

    Measured by accelerometry.

    Time frame: Day: 7

  2. Low activity time in hours per week (hours/week)

    Measured by accelerometry.

    Time frame: Day: 7

  3. Moderate activity time in hours per week (hours/week)

    Measured by accelerometry.

    Time frame: Day: 7

  4. Intense activity time in hours per week (hours/week)

    Measured by accelerometry.

    Time frame: Day: 7

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

    Measured by accelerometry.

    Time frame: Day: 7

  6. Sleep time in hours per week (hours/week)

    Measured by accelerometry.

    Time frame: Day: 7

  7. 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.

    Time frame: Day: 7

  8. 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.

    Time frame: Day: 7

  9. Dosage of albumin (g/L)

    Measured by blood sample.

    Time frame: Day: 7

  10. Dosage of prealbumin (g/L)

    Measured by blood sample.

    Time frame: Day: 7

  11. Preoperative strength assessed by dynamometry (Kg)

    Measured by Hand Grip test.

    Time frame: Day: 14

  12. Relationship between preoperative physical activity and duration of stay in intensive care

    Correlation between preoperative physical activity and duration of stay in intensive care.

    Time frame: Months: 26

  13. Preoperative clinical outcome and duration of stay in intensive care

    Correlation between preoperative clinical outcome and duration of stay in intensive care.

    Time frame: Months: 26

  14. Postoperative clinical outcome and duration of stay in intensive care

    Correlation between postoperative clinical outcome and duration of stay in intensive care.

    Time frame: Months: 26

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Study locations

1 site
  • Chu Saint-Etienne
    Saint-Étienne, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04140331
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Oct 25, 2019
Start date
Jan 9, 2020
Primary completion
Apr 2, 2024
Completion
Jun 4, 2024
Last update
Jun 18, 2024

Study contacts

Jean-Charles PALAO, MD
principal investigator · CHU SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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