BRacelet And Physical actiVity Evaluation (BRAVE) (BRAVE)

October 22, 2018 updated by: Nicolas DEMARTINES, University of Lausanne Hospitals

Evaluation of Pre- and Post-operative Physical Activity on Postoperative Rehabilitation After Colorectal Surgery With a Connected Device

The aim of this study is to quantify pre- and postoperative physical activity of patients operated on colorectal surgery. Daily physical activity (No. of footsteps) is going to be recorded from 15 days before surgery to the end of hospitalization after surgery in a prospective cohort of consecutive colorectal patients by use of an attached strap. Then, the investigators will propose physical activity thresholds (adapted to the age, gender and patient comorbidities) to optimize the ERAS protocol (Enhanced Rehabilitation After Surgery). Thus, this analysis will allow the investigators to provide patients with physical rehabilitation programs "a la carte" during a hospitalization for colorectal surgery. Connected bracelets will directly involve patients in their care and rehabilitation.

Study Overview

Status

Completed

Conditions

Detailed Description

Connected bracelet will be given to 50 consecutive patients undergone colorectal surgery 15 days before surgery. The investigators will measure pre- and postoperative physical activity. It is an observational activity of patient's physical activity during the perioperative period with no intervention.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1011
        • Department of Visceral Surgery, University Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who undergo colorectal surgery

Description

Inclusion Criteria:

1. Patients with a colorectal surgery

Exclusion Criteria:

  1. Limitation of linguistic or cognitive abilities, interfering with the understanding of the study protocol
  2. Lack of consent of the study form
  3. Emergency Surgery
  4. stoma closure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Connected bracelet
Patients with a colorectal surgery planned will be included. Fifteen days before surgery, patients will have a connected bracelet permitting to quantify the number of steps and distance achieved each day before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre- and postoperative physical activity
Time Frame: 30 days
Number of footsteps
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 30 days
score (number between 0 to 10)
30 days
Quality of sleep
Time Frame: 30 days
Score (number between 0 to 10)
30 days
Pain
Time Frame: 30 days
Score (number between 0 to 10)
30 days
Fatigue
Time Frame: 30 days
Score (number between 0 to 10)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Investigators

  • Principal Investigator: Nicolas DEMARTINES, Lausanne University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

November 8, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimate)

November 20, 2015

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 383/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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