Contribution of Connected Devices in the Follow-up of the Observance of a Prehabilitation Program (Prehab-Connect)
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|ClinicalTrials.gov Identifier: NCT03363009|
Recruitment Status : Suspended (Logistical issues)
First Posted : December 5, 2017
Last Update Posted : August 15, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- Functional capacity [ Time Frame: 2 months ]6 minutes walk test
- Functional capacity [ Time Frame: 2 months ]Maximal oxygen consumption
- Critical events [ Time Frame: 2 months ]Number of critical events detected using the connected devices
- Postoperative complications [ Time Frame: 2 months ]Number of complication during the 2 months following surgery according to Dindo and Clavien classification
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
|Principal Investigator:||Barizien Nicolas, MD||Hopital Foch|
|Study Chair:||Marc Fischler||Hopital Foch|