Contribution of Connected Devices in the Follow-up of the Observance of a Prehabilitation Program (Prehab-Connect)

March 15, 2021 updated by: Hopital Foch

Poor physical performance and poor nutritional status increase the risk of complications after major surgery. Prehabilitation is the process of enhancing the functional capacity before surgery.

A major problem is the adherence of the patients to the physical program. A controlled randomized study is therefore proposed to determine the impact of coaching on functional exercise capacity. All patients will wear connected devices to measure their physical activity. They will be randomized to either a group in which coaching will be adapted to the physical activity, or a control group in which coaching is performed without any information about physical activity

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France
        • Foch Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged over 18
  • Patients scheduled for a surgical procedure 4 weeks later (more or less 1 week) after initial assessment
  • Patients having consented to participate
  • Patients benefiting from a social security system.

Exclusion Criteria:

  • Pregnant or lactating women
  • Inability to perform physical assessment
  • Dependant patients
  • Inability to complete questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Connected device with close following
Data from connected devices (arm wrist watch, connected monitor of blood pressure, connected thermometer and pulse oximeter) will be analyzed every day and used for coaching
Device: Optimized group
The data provided by the connected devices is analyzed daily; the patient receives a phone call in case of no realization of the objectives.
Other: Connected device with standard coaching
Data from connected devices (arm wrist watch, connected monitor of blood pressure, connected thermometer and pulse oximeter) will be saved but not used for coaching
Device: Control group
Data will be recorded but not analyzed daily during the period of participation. The patient receives a phone call one time a week to answer possible questions and modify the prescription of physical activity if need.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity
Time Frame: 2 months
6 minutes walk test
2 months
Functional capacity
Time Frame: 2 months
Maximal oxygen consumption
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Critical events
Time Frame: 2 months
Number of critical events detected using the connected devices
2 months
Postoperative complications
Time Frame: 2 months
Number of complication during the 2 months following surgery according to Dindo and Clavien classification
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Barizien Nicolas, MD, Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

November 23, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016/32
  • 2016- A01086-45 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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