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

NCT03363009 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-03-16

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Hopital Foch

    lead OTHER

Principal Investigators

  • Barizien Nicolas, MD · Hopital Foch

  • Marc Fischler · Hopital Foch

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-04
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03363009 on ClinicalTrials.gov