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

NCT03363009 | Terminated

• 2 other identifiers: 2016/322016- A01086-45
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Surgery

Keywords

prehabilitation; connected devices

Outcome Measures

Primary Outcomes (2)

• Functional capacity

  6 minutes walk test

  2 months

• Functional capacity

  Maximal oxygen consumption

  2 months

Secondary Outcomes (2)

• Critical events

  2 months

• Postoperative complications

  2 months

Study Arms (2)

Connected device with close following

EXPERIMENTAL

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

Connected device with standard coaching

OTHER

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

Interventions

Optimized group 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 close following

Control group 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.

Connected device with standard coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Foch hospital

Suresnes, France

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Barizien Nicolas, MD

  Hopital Foch

  PRINCIPAL INVESTIGATOR

• Marc Fischler

  Hopital Foch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: December 5, 2017
• Study Start: December 4, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

FR (1)