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Completed

NCT Number: NCT02833324

Fitbit for Postoperative Ambulation

This trial will investigate whether using reminder alarms with a wireless activity tracking device (Fitbit) will increase daily ambulation in individuals who have just had colorectal surgery.

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Key information

Conditions

Postoperative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital

Atlanta, Georgia, 30322, United States

About this study

Early mobilization after surgery has been shown to reduce recovery time, incidence of venous thromboembolism, length of hospital stay and both pulmonary and general post-operative complications. Ambulation is also a main tenant of a fast-track recovery protocol known as Enhanced Recovery After Surgery (ERAS), which is commonly used among colorectal surgical practices and being implanted across other surgical practices. Despite evidence supporting its benefit, early ambulation has been identified as the one of the most difficult clinical interventions to enforce and to measure.

The primary objective of this trial is to investigate whether the use of wireless activity tracking device (Fitbit) with 5 daily reminder alarms will increase daily ambulation on postoperative day 0 until post operative day 9 or hospital discharge (whichever occurs first). Secondary objectives include evaluating the effect of Fitbit as a motivating factor on the frequency of postoperative ileus, time to return of bowel function, number of venous thromboembolism (VTE), pneumonia (PNA) and other pulmonary complications, number of code Medical Emergency Team (MET) alerts, and overall cost saving.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergoing an elective surgical procedure in colorectal services at Emory University Hospital

Exclusion criteria

  • Post-surgical admission into the intensive care unit (ICU)
  • Have an open abdomen due to surgical complications
  • Wound Vacuum Assisted Closure (VAC) dependent

Treatment and study plan

Education regarding ambulation

Behavioral

The participants will be educated on the importance of postoperative ambulation during the recovery period.

Ambulation reminder alarms

Behavioral

Participants in the intervention arm will receive 5 daily alarms to prompt them to ambulate. Alarms will be set to ring at 9am, 11am, 2pm, 5pm and 9pm. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first.

FitBit

Other

Participants who are postoperative for colorectal surgery, who have been cleared to ambulate during recover, will be equipped with an off-the-shelf Fitbit device (a wireless activity tracking device) which will record steps taken while the participant is hospitalized. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first.

Primary outcomes

  1. Comparison of number of steps taken between study arms

    Time frame: Up to 10 days (postoperative day 0 through postoperative day 9)

    The number of steps taken by each participant will be measured by a Fitbit, which is a wireless activity tracking device. The number of steps taken will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. The Fitbit is commercially available and is worn on the wrist. Data will be collected from the Fitbit wirelessly using a dedicated study data collection phone and linked with an anonymized patient identifier. Data collection phones attached to chargers will be placed in patient rooms within range of the hospital bed to enable automatic wireless data collection.

Secondary outcomes

  1. Comparison of time to first ambulation between study arms

    Time frame: Up to 10 days (postoperative day 0 through postoperative day 9)

    The duration of time from administration of the Fitbit device until first postoperative ambulation will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. Participants cleared to ambulate will be given a package containing the Fitbit device, paired study phone, and chargers while in the Post Anesthesia Care Unit (PACU). Participants will be instructed to equip the device prior to discharge from the PACU.

  2. Comparison of incidence of prolonged postoperative ileus between study arms

    Time frame: Up to 10 days (postoperative day 0 through postoperative day 9)

    The incidence of prolonged postoperative ileus during hospitalization will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms.

    For this study, postoperative ileus is defined as the interval from surgery until there is passage of flatus or stool and an oral diet is tolerated. Prolonged postoperative ileus is determined to be present if two or more of the following criteria are met on or after postoperative day 4, without prior resolution of postoperative ileus:

    • Nausea or vomiting
    • The inability to tolerate an oral diet over 24 hours
    • Absence of flatus over 24 hours
    • Abdominal distension
    • Radiologic confirmation

  3. Comparison of incidence of pulmonary complications between study arms

    Time frame: Up to 10 days (postoperative day 0 through postoperative day 9)

    The incidence of pulmonary complications during hospitalization will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. For this study, pulmonary complications are defined as respiratory failure requiring mechanical ventilation, pneumonia, atelectasis requiring bronchoscopic intervention, or pneumothorax or pleural effusion requiring percutaneous intervention.

  4. Comparison of incidence of venous thromboembolism between study arms

    Time frame: Up to 10 days (postoperative day 0 through postoperative day 9)

    The incidence of venous thromboembolism occurring during hospitalization will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. Venous thromboembolism is when a blood clot (thrombus) forms within a vein and includes deep vein thrombosis (DVT) and pulmonary embolism (PE).

  5. Comparison of length of postoperative hospital stay between study arms

    Time frame: Up to 10 days (postoperative day 0 through postoperative day 9)

    The length of hospitalization following surgery will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Can a Fitbit (a Mobile Tracking Device) Increase Ambulation of Colorectal Surgical Patients in the Postoperative Period?

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2016
Registry last updated
Oct 17, 2017

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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