Cardiac SurgeryBECSuPNCT03113565
Connected Electronic Wrist Strap for Patient Follow-up After Cardiac Surgery
An observational study of Cardiac Surgery and Surgery--Complications, run by CMC Ambroise Paré at 1 site in France.
Trial summary
After cardiac surgery, patients' follow-up after discharge is a major public health issue. Since the main complications occur mostly during the first extra-hospital month, a follow-up period becomes necessary as the average duration of hospitalization tends to decrease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Surgery--Complications, Cardiac Disease
- What is being tested?
- Count daily number of footsteps.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- 9 Aug 2017to 10 Jun 2018
- How long will I take part?
- 2 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent elective cardiac surgery, regardless of indication and type of intervention.
Who may be able to join
- Adult patients who underwent elective cardiac surgery, regardless of indication and type of intervention.
Who cannot join
- Refuse of the patient,
- Misunderstanding of the system (electronic wristband, application) or the principle of the study (language problem, cerebral vascular sequelae),
- Pre-existing handicap that does not allow walking (not related to the cardiac pathology leading to the planned cardiac surgery).
- Patients who are unable to understand the content of the information delivered
- Pregnant women can not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
After cardiac surgery, patients' follow-up after discharge is a major public health issue. Since the main complications occur mostly during the first extra-hospital month, a follow-up period becomes necessary as the average duration of hospitalization tends to decrease. The resumption of normal physical activity is rarely transmitted and when complications arise, the healthcare team is most often informed late.
An electronic wristband is worn by the patient during the day, between the day of discharge from the hospital (D0) and the end of the second extra-hospital month (D60). The data recorded by the wristband include : bracelet ID, date, time and number of steps per day.
Read more
The primary objective of the study is to measure the resumption of physical activity after elective cardiac surgery. This objective will be quantified by the number of daily footsteps.
A secondary objective is to determine perioperative predictors of the physical resumption.
- Being tested
- Count daily number of footsteps.
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Count daily number of footsteps.Behavioural
Using a connected electronic wristband to mainly quantify daily number of footsteps.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the resumption of physical activity after cardiac surgery by counting the number of daily footsteps.
Count the number of daily footsteps
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start9 Aug 2017
- Primary completion10 Jun 2018
- Study completion10 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- 137 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113565
- Sponsor's protocol ID
- 2016/02
- Acronym
- BECSuP
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2017
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ball L, Costantino F, Pelosi P. Postoperative complications of patients undergoing cardiac surgery. Curr Opin Crit Care. 2016 Aug;22(4):386-92. doi: 10.1097/MCC.0000000000000319.
PubMed 27309972Kim DH, Kim CA, Placide S, Lipsitz LA, Marcantonio ER. Preoperative Frailty Assessment and Outcomes at 6 Months or Later in Older Adults Undergoing Cardiac Surgical Procedures: A Systematic Review. Ann Intern Med. 2016 Nov 1;165(9):650-660. doi: 10.7326/M16-0652. Epub 2016 Aug 23.
PubMed 27548070Mazzeffi M, Zivot J, Buchman T, Halkos M. In-hospital mortality after cardiac surgery: patient characteristics, timing, and association with postoperative length of intensive care unit and hospital stay. Ann Thorac Surg. 2014 Apr;97(4):1220-5. doi: 10.1016/j.athoracsur.2013.10.040. Epub 2013 Dec 21.
PubMed 24360878Hulzebos EH, Smit Y, Helders PP, van Meeteren NL. Preoperative physical therapy for elective cardiac surgery patients. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD010118. doi: 10.1002/14651858.CD010118.pub2.
PubMed 23152283Mainini C, Rebelo PF, Bardelli R, Kopliku B, Tenconi S, Costi S, Tedeschi C, Fugazzaro S. Perioperative physical exercise interventions for patients undergoing lung cancer surgery: What is the evidence? SAGE Open Med. 2016 Oct 19;4:2050312116673855. doi: 10.1177/2050312116673855. eCollection 2016.
PubMed 27803808Hauguel-Moreau M, Naudin C, N'Guyen L, Squara P, Rosencher J, Makowski S, Beverelli F. Smart bracelet to assess physical activity after cardiac surgery: A prospective study. PLoS One. 2020 Dec 1;15(12):e0241368. doi: 10.1371/journal.pone.0241368. eCollection 2020.
PubMed 33259484
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connected Electronic Wrist Strap for Patient Follow-up After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03113565
- Acronym / sponsor ID
- BECSuP / 2016/02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 10 Jun 2018 (actual)
- First posted
- 13 Apr 2017 (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.
After cardiac surgery, patients' follow-up after discharge is a major public health issue. Since the main complications occur mostly during the first extra-hospital month, a follow-up period becomes necessary as the average duration of hospitalization tends to decrease. The resumption of normal physical activity is rarely transmitted and when complications arise, the healthcare team is most often informed late.
An electronic wristband is worn by the patient during the day, between the day of discharge from the hospital (D0) and the end of the second extra-hospital month (D60). The data recorded by the wristband include : bracelet ID, date, time and number of steps per day.
The primary objective of the study is to measure the resumption of physical activity after elective cardiac surgery. This objective will be quantified by the number of daily footsteps.
A secondary objective is to determine perioperative predictors of the physical resumption.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent elective cardiac surgery, regardless of indication and type of intervention.
Key inclusion criteria (1 listed)
- Adult patients who underwent elective cardiac surgery, regardless of indication and type of intervention.
Key exclusion criteria (5 listed)
- Refuse of the patient,
- Misunderstanding of the system (electronic wristband, application) or the principle of the study (language problem, cerebral vascular sequelae),
- Pre-existing handicap that does not allow walking (not related to the cardiac pathology leading to the planned cardiac surgery).
- Patients who are unable to understand the content of the information delivered
- Pregnant women can not be included in the study.
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 |
|---|---|---|
| Count daily number of footsteps.Using a connected electronic wristband to mainly quantify daily number of footsteps. | Behavioural | – |
Primary outcome
Measure the resumption of physical activity after cardiac surgery by counting the number of daily footsteps.
Time frame: 2 months
Count the number of daily footsteps
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 27309972Ball L, Costantino F, Pelosi P. Postoperative complications of patients undergoing cardiac surgery. Curr Opin Crit Care. 2016 Aug;22(4):386-92. doi: 10.1097/MCC.0000000000000319.
- Background: PubMed 27548070Kim DH, Kim CA, Placide S, Lipsitz LA, Marcantonio ER. Preoperative Frailty Assessment and Outcomes at 6 Months or Later in Older Adults Undergoing Cardiac Surgical Procedures: A Systematic Review. Ann Intern Med. 2016 Nov 1;165(9):650-660. doi: 10.7326/M16-0652. Epub 2016 Aug 23.
- Background: PubMed 24360878Mazzeffi M, Zivot J, Buchman T, Halkos M. In-hospital mortality after cardiac surgery: patient characteristics, timing, and association with postoperative length of intensive care unit and hospital stay. Ann Thorac Surg. 2014 Apr;97(4):1220-5. doi: 10.1016/j.athoracsur.2013.10.040. Epub 2013 Dec 21.
- Background: PubMed 23152283Hulzebos EH, Smit Y, Helders PP, van Meeteren NL. Preoperative physical therapy for elective cardiac surgery patients. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD010118. doi: 10.1002/14651858.CD010118.pub2.
- Background: PubMed 27803808Mainini C, Rebelo PF, Bardelli R, Kopliku B, Tenconi S, Costi S, Tedeschi C, Fugazzaro S. Perioperative physical exercise interventions for patients undergoing lung cancer surgery: What is the evidence? SAGE Open Med. 2016 Oct 19;4:2050312116673855. doi: 10.1177/2050312116673855. eCollection 2016.
- Results publication: PubMed 33259484Hauguel-Moreau M, Naudin C, N'Guyen L, Squara P, Rosencher J, Makowski S, Beverelli F. Smart bracelet to assess physical activity after cardiac surgery: A prospective study. PLoS One. 2020 Dec 1;15(12):e0241368. doi: 10.1371/journal.pone.0241368. eCollection 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Surgery and Surgery--Complications, run by CMC Ambroise Paré 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 8 Apr 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure the resumption of physical activity after cardiac surgery by counting the number of daily footsteps. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03113565, which also lists 6 linked publications.
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 8 Apr 2026.