Use of Wearable Activity Tracker in Elderly Undergoing Abdominal Surgery

NCT03175783 | Unknown DMC

• 1 other identifier: 36100
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Early mobilization is an important element in Enhanced Recovery After Surgery (ERAS). It reduces risk of conditions which are related to prolonged bed rest such as deep vein thrombosis, lung atelectasis, pneumonia, and sacral sore. (Appelboom, Taylor et al. 2015) It is also associated with shortened length of hospital stay, improved survival, and reduction in health care cost. However, "early mobilization" was not defined consistently in previous study. Some authors recommend patients to get out of bed and ambulate on the day of operation while others define as getting out of bed more than 2 hours on day of operation and up to 8 hours on second post-operative day. (Wolk, Meissner et al. 2017) The inconsistency in definition is partly due to the inability to quantify patients' mobility which is usually self-reported by patients and is subjective.(Eva van der Meij 2017) This is especially true for elderly patient in whom preoperative mobility varies significantly between individuals. For this reason, the approach of early mobilization in elderly should be goal directed and individualized according to their preoperative mobility and functional status. The aim of current study is to monitor and motivate elderly patients undergoing abdominal surgery to increase postoperative mobilization by using Fitbit Zip activity tracker.

Conditions

Fitness Trackers; Early Ambulation; Surgery; Health Services for the Aged

Outcome Measures

Primary Outcomes (1)

• Postoperative mobility measured by mean step counts

  Comparing mean step counts between treatment and control group

  14 days

Secondary Outcomes (3)

• Percent change in postoperative mobility

  14 days

• Effect of activity tracker with automatic feedback on length of hospital stay

  up to one month

• Number of patients with post operative complications

  up to one month

Study Arms (2)

Treatment Group

EXPERIMENTAL

Treatment group will receive intervention by putting on Fitbit Zip activity tracker with automatic step counts feedback throughout the study.

Device: Fitbit Zip Activity Tracker

Control Group

SHAM COMPARATOR

Control group will be put on intervention with same Fitbit Zip activity tracker but without automatic feedback for same duration of intervention.

Device: Fitbit Zip Activity Tracker

Interventions

Fitbit Zip Activity Tracker DEVICE

Subjects from both treatment and control group will be put on wristband starting from one week before the scheduled operation until 7 post-operative days. Patients will be instructed to wear the wristband continuously 24 hours per day except during water based activity. The treatment group will receive normal wristband with indicator showing steps count, distance, and calories. Meanwhile, the control group will receive Fitbit Zip with a display covered with adhesive tape and will not receive automatic feedback on the mobility from the device.

Control Group; Treatment Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult age \>60 years old
• Patients electively scheduled for abdominal surgery includes upper gastro-intestinal surgery (subtotal gastrectomy, partial gastrectomy), colorectal surgery (hemicolectomy, anterior resection, sigmoidectomy, abdominal perineal resection), and hepatobiliary surgery ( pancreatectomy, cholecystectomy, hepatectomy)
• Able to provide informed consent

You may not qualify if:

• Cognitive impairment
• Neurological deficit which requires assistance in mobilization (e.g stroke, post limb amputation)
• Emergency surgery
• Prolonged ventilation \>24 hours
• Prolonged stay in ICU \>48 hours
• Lack of compliance to wearing wrist band
• Allergic to wristband

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia

RECRUITING

Related Publications (7)

• Appelboom G, Taylor BE, Bruce E, Bassile CC, Malakidis C, Yang A, Youngerman B, D'Amico R, Bruce S, Bruyere O, Reginster JY, Dumont EP, Connolly ES Jr. Mobile Phone-Connected Wearable Motion Sensors to Assess Postoperative Mobilization. JMIR Mhealth Uhealth. 2015 Jul 28;3(3):e78. doi: 10.2196/mhealth.3785.

  PMID: 26220691 BACKGROUND

• Cook DJ, Thompson JE, Prinsen SK, Dearani JA, Deschamps C. Functional recovery in the elderly after major surgery: assessment of mobility recovery using wireless technology. Ann Thorac Surg. 2013 Sep;96(3):1057-61. doi: 10.1016/j.athoracsur.2013.05.092.

  PMID: 23992697 BACKGROUND

• van der Meij E, van der Ploeg HP, van den Heuvel B, Dwars BJ, Meijerink WJHJ, Bonjer HJ, Huirne JAF, Anema JR. Assessing pre- and postoperative activity levels with an accelerometer: a proof of concept study. BMC Surg. 2017 May 12;17(1):56. doi: 10.1186/s12893-017-0223-0.

  PMID: 28494785 BACKGROUND

• Gualtieri L, Rosenbluth S, Phillips J. Can a Free Wearable Activity Tracker Change Behavior? The Impact of Trackers on Adults in a Physician-Led Wellness Group. JMIR Res Protoc. 2016 Nov 30;5(4):e237. doi: 10.2196/resprot.6534.

  PMID: 27903490 BACKGROUND

• Paul SS, Tiedemann A, Hassett LM, Ramsay E, Kirkham C, Chagpar S, Sherrington C. Validity of the Fitbit activity tracker for measuring steps in community-dwelling older adults. BMJ Open Sport Exerc Med. 2015 Jul 8;1(1):e000013. doi: 10.1136/bmjsem-2015-000013. eCollection 2015.

  PMID: 27900119 BACKGROUND

• Wolk S, Meissner T, Linke S, Mussle B, Wierick A, Bogner A, Sturm D, Rahbari NN, Distler M, Weitz J, Welsch T. Use of activity tracking in major visceral surgery-the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial. Trials. 2017 Feb 21;18(1):77. doi: 10.1186/s13063-017-1782-1.

  PMID: 28222805 BACKGROUND

• Dupont WD, Plummer WD Jr. Power and sample size calculations for studies involving linear regression. Control Clin Trials. 1998 Dec;19(6):589-601. doi: 10.1016/s0197-2456(98)00037-3.

  PMID: 9875838 BACKGROUND

Study Officials

• Wong Koh Ging, MD

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wong Koh Ging, MD

CONTACT

082276666; kohging@ummc.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 27, 2017
• First Posted: June 5, 2017
• Study Start: July 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)