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

Surgery Clinical Trial

— Prehab-Connect  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03363009
• Other study ID #: 2016/32
• Secondary ID: 2016- A01086-45
• Status: Terminated
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
France	Foch hospital	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity	6 minutes walk test	2 months
Primary	Functional capacity	Maximal oxygen consumption	2 months
Secondary	Critical events	Number of critical events detected using the connected devices	2 months
Secondary	Postoperative complications	Number of complication during the 2 months following surgery according to Dindo and Clavien classification	2 months