BRacelet And Physical actiVity Evaluation (BRAVE) (BRAVE)

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: Physical Activity

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	Number of footsteps	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Investigators: Principal Investigator: Nicolas DEMARTINES, Lausanne University Hospital

Study record dates

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: connected bracelets, footsteps
• Other Study ID Numbers: 383/15