Contribution of Connected Devices in the Follow-up of the Observance of a Prehabilitation Program

Not Applicable

Terminated

• Conditions: Surgery
• Interventions: Device: Optimized group; Device: Control group

• Registration Number: NCT03363009
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-23
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-05
• Study Start: 2018-12-04
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Connected device with close following	Optimized group	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
Connected device with standard coaching	Control group	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

Primary Outcome Measures

Name	Time	Method
Functional capacity	2 months	Maximal oxygen consumption

Secondary Outcome Measures

Name	Time	Method
Critical events	2 months	Number of critical events detected using the connected devices
Postoperative complications	2 months	Number of complication during the 2 months following surgery according to Dindo and Clavien classification

Trial Locations

Locations (1)

Foch hospital; 🇫🇷 Suresnes, France