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

Study Overview
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Brief Summary
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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

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

Conditions
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Surgery

Intervention / Treatment
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* Device: Optimized group
* Device: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connected device with close following<br>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<br>* The data provided by the connected devices is analyzed daily; the patient receives a phone call in case of no realization of the objectives.<br>|
| Other: Connected device with standard coaching<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prehabilitation, connected devices