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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2020-12-31

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

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Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Optimized group

Intervention Type DEVICE

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

Group Type OTHER

Control group

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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.