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

Hopital Foch

Status: Terminated

Conditions: Surgery

Treatments: Device: Optimized group; Device: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03363009

2016- A01086-45 (Other Identifier)

2016/32

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Connected device with close following

Experimental group

Description:

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

Treatment:

Device: Optimized group

Connected device with standard coaching

Other group

Description:

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

Treatment:

Device: Control group