BRacelet And Physical actiVity Evaluation (BRAVE) | NCT02610790

Studies
BRacelet And Physical actiVity Evaluation (BRAVE)

NCT02610790

Sponsor

University of Lausanne Hospitals

Status

Completed

Last Update Posted

Oct 23, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Physical Activity

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Sep 2018Actual

Completion Date

Oct 2018Actual

First Submitted Date

Nov 8, 2015

First Submission Date that Met QC Criteria

Nov 18, 2015

First Posted Date

Nov 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2018

Last Update Posted Date

Oct 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nicolas DEMARTINES, Chief Department, University of Lausanne HospitalsPrincipal Investigator

Lead Sponsor

University of Lausanne HospitalsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Patients with a colorectal surgery

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who undergo colorectal surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolas DEMARTINES	University of Lausanne Hospitals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Visceral Surgery, University Hospital Center		Lausanne		1011	Switzerland