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Completed

NCT Number: NCT02610790

BRacelet And Physical actiVity Evaluation (BRAVE)

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.

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Key information

Conditions

Physical Activity Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Visceral Surgery, University Hospital Center

Lausanne, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Pre- and postoperative physical activity

    Time frame: 30 days

    Number of footsteps

Secondary outcomes

  1. Quality of life

    Time frame: 30 days

    score (number between 0 to 10)

  2. Quality of sleep

    Time frame: 30 days

    Score (number between 0 to 10)

  3. Pain

    Time frame: 30 days

    Score (number between 0 to 10)

  4. Fatigue

    Time frame: 30 days

    Score (number between 0 to 10)

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

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

Acronym: BRAVE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2015
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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