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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03363009

Acronym

Prehab-Connect

Enrollment

100

Registered

2017-12-05

Start date

2018-12-04

Completion date

2020-12-31

Last updated

2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

prehabilitation, connected devices

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

Interventions

DEVICEOptimized 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.

DEVICEControl 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Functional capacity	2 months	6 minutes walk test

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026