NCT03113565

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

August 9, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2018

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 10, 2017

Last Update Submit

April 2, 2026

Conditions

Cardiac SurgerySurgery--ComplicationsCardiac DiseasePhysical Disability

Outcome Measures

Primary Outcomes (1)

  • Measure the resumption of physical activity after cardiac surgery by counting the number of daily footsteps.

    Count the number of daily footsteps

    2 months

Interventions

Count daily number of footsteps.BEHAVIORAL

Using a connected electronic wristband to mainly quantify daily number of footsteps.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who underwent elective cardiac surgery, regardless of indication and type of intervention.

You may qualify if:

  • Adult patients who underwent elective cardiac surgery, regardless of indication and type of intervention.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cmc Ambroise Pare

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

Related Publications (6)

  • 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.

    PMID: 27309972BACKGROUND

  • Kim 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.

    PMID: 27548070BACKGROUND

  • Mazzeffi 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.

    PMID: 24360878BACKGROUND

  • Hulzebos 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.

    PMID: 23152283BACKGROUND

  • Mainini 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.

    BACKGROUND

  • Hauguel-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.

    PMID: 33259484RESULT

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 13, 2017

Study Start

August 9, 2017

Primary Completion

June 10, 2018

Study Completion

June 10, 2018

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)