BRacelet And Physical actiVity Evaluation (BRAVE)

Physical Activity Clinical Trial

— BRAVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610790
• Other study ID #: 383/15
• Status: Completed
• Start date: June 2016
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity

Locations

Country	Name	City	State
Switzerland	Department of Visceral Surgery, University Hospital Center	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre- and postoperative physical activity	Number of footsteps	30 days
Secondary	Quality of life	score (number between 0 to 10)	30 days
Secondary	Quality of sleep	Score (number between 0 to 10)	30 days
Secondary	Pain	Score (number between 0 to 10)	30 days
Secondary	Fatigue	Score (number between 0 to 10)	30 days