Heart DiseasesACTI-CARDNCT04140331
Level of Accelerometer-assessed Preoperative Physical Activity and Short Term Outcome After Elective Cardiac Surgery
An observational study of Heart Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Accelerometer
- Type of treatment
- Medical device
- How many people
- 202 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2020to 4 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subject (≥ 60 years) awaiting elective cardiac surgery will be included.
Who may be able to join
- 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
Who cannot join
- Pregnant woman,
- Major limitations in physical activity for orthopedic or musculoskeletal reasons
- Patients under judicial protection (curator or guardianship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Level of Accelerometer-assessed Preoperative Physical Activity and Short Term Outcome After Elective Cardiac Surgery. A Monocentric Prospective Observational Cohort Study
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.
- Conditions
- Heart Diseases
- Being tested
- Accelerometer
- Keywords
- Post-operative evolution, Accelerometer, Cardiac surgery, Accelerometry, Preoperative physical activity
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometerDevice
Patient will wear the accelerometer for 7 consecutive days to measure the level of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean daily preoperative walking activity (average of steps/day over a period of 7 days)
Measured by accelerometry.
Measured: Day: 7
Secondary outcomes (14)
Total energy expenditure evaluated over a 7 days (steps/day)
Measured by accelerometry.
Measured: Day: 7
Low activity time in hours per week (hours/week)
Measured by accelerometry.
Measured: Day: 7
Moderate activity time in hours per week (hours/week)
Measured by accelerometry.
Measured: Day: 7
Intense activity time in hours per week (hours/week)
Measured by accelerometry.
Measured: Day: 7
Time of very intense activity in hours per week (hours/week)
Measured by accelerometry.
Measured: Day: 7
Sleep time in hours per week (hours/week)
Measured by accelerometry.
Measured: Day: 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.
Measured: Day: 7
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.
Measured: Day: 7
Dosage of albumin (g/L)
Measured by blood sample.
Measured: Day: 7
Dosage of prealbumin (g/L)
Measured by blood sample.
Measured: Day: 7
Preoperative strength assessed by dynamometry (Kg)
Measured by Hand Grip test.
Measured: Day: 14
Relationship between preoperative physical activity and duration of stay in intensive care
Correlation between preoperative physical activity and duration of stay in intensive care.
Measured: Months: 26
Preoperative clinical outcome and duration of stay in intensive care
Correlation between preoperative clinical outcome and duration of stay in intensive care.
Measured: Months: 26
Postoperative clinical outcome and duration of stay in intensive care
Correlation between postoperative clinical outcome and duration of stay in intensive care.
Measured: Months: 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start9 Jan 2020
- Primary completion2 Apr 2024
- Study completion4 Jun 2024
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Charles PALAO, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140331
- Sponsor's protocol ID
- 19CH049
- Other IDs
- 2019-A00525-52
- Acronym
- ACTI-CARD
- Status last verified
- Jun 2024
- First submitted
- 24 Oct 2019
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level of Accelerometer-assessed Preoperative Physical Activity and Short Term Outcome After Elective Cardiac Surgery. A Monocentric Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04140331
- Acronym / sponsor ID
- ACTI-CARD / 19CH049
- Conditions
- Heart Diseases
- Keywords
- Post-operative evolution, Accelerometer, Cardiac surgery, Accelerometry, Preoperative physical activity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complicated post-operative evolution | – | Device: AccelerometerPatients with a postoperative intensive care unity length of stay ≥ 5 days after elective cardiac surgery. They will have an accelerometer. |
| simple post-operative evolution | – | Device: AccelerometerPatients with a postoperative intensive care unity length of stay < 5 days after elective cardiac surgery. They will have an accelerometer. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subject (≥ 60 years) awaiting elective cardiac surgery will be included.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant woman,
- Major limitations in physical activity for orthopedic or musculoskeletal reasons
- Patients under judicial protection (curator or guardianship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccelerometerPatient will wear the accelerometer for 7 consecutive days to measure the level of physical activity. | Device | complicated post-operative evolution, simple post-operative evolution |
Primary outcome
Mean daily preoperative walking activity (average of steps/day over a period of 7 days)
Time frame: Day: 7
Measured by accelerometry.
14 secondary outcomes
Total energy expenditure evaluated over a 7 days (steps/day)
Time frame: Day: 7
Low activity time in hours per week (hours/week)
Time frame: Day: 7
Moderate activity time in hours per week (hours/week)
Time frame: Day: 7
Intense activity time in hours per week (hours/week)
Time frame: Day: 7
Time of very intense activity in hours per week (hours/week)
Time frame: Day: 7
Sleep time in hours per week (hours/week)
Time frame: Day: 7
Analysis of questionary Duke Activity Status Index (DASI) over a period of 7 days
Time frame: Day: 7
Analysis of questionary Short Nutritional Assessment Questionnaire (SNAQ) over a period of 7 days
Time frame: Day: 7
Dosage of albumin (g/L)
Time frame: Day: 7
Dosage of prealbumin (g/L)
Time frame: Day: 7
Preoperative strength assessed by dynamometry (Kg)
Time frame: Day: 14
Relationship between preoperative physical activity and duration of stay in intensive care
Time frame: Months: 26
Preoperative clinical outcome and duration of stay in intensive care
Time frame: Months: 26
Postoperative clinical outcome and duration of stay in intensive care
Time frame: Months: 26
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Charles PALAO, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean daily preoperative walking activity (average of steps/day over a period of 7 days) (time frame: Day: 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.