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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363009
Recruitment Status : Suspended (Logistical issues)
First Posted : December 5, 2017
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Surgery Device: Optimized group Device: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Contribution of Connected Devices in the Follow-up of the Observance of a Prehabilitation Program
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

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.

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.




Primary Outcome Measures :
  1. Functional capacity [ Time Frame: 2 months ]
    6 minutes walk test

  2. Functional capacity [ Time Frame: 2 months ]
    Maximal oxygen consumption


Secondary Outcome Measures :
  1. Critical events [ Time Frame: 2 months ]
    Number of critical events detected using the connected devices

  2. Postoperative complications [ Time Frame: 2 months ]
    Number of complication during the 2 months following surgery according to Dindo and Clavien classification



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363009


Locations
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France
Foch hospital
Suresnes, France
Sponsors and Collaborators
Hopital Foch
Investigators
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Principal Investigator: Barizien Nicolas, MD Hopital Foch
Study Chair: Marc Fischler Hopital Foch
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03363009    
Other Study ID Numbers: 2016/32
2016- A01086-45 ( Other Identifier: ANSM )
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hopital Foch:
prehabilitation
connected devices