Use of Wearable Activity Tracker in Elderly Undergoing Abdominal Surgery

Use of Wearable Activity Tracker to Monitor and Increase Mobility for Elderly Undergoing Abdominal Surgery: A Randomized Control Trial

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.

Study Overview

• Status: Unknown
• Conditions: Surgery; Fitness Trackers; Early Ambulation; Health Services for the Aged
• Intervention / Treatment: Device: Fitbit Zip Activity Tracker

Detailed Description

This is a randomized, controlled, single center trial comparing the use of activity tracker with and without automatic feedback in improving postoperative mobility of elderly patients undergoing abdominal surgery.

Selected subjects will be randomized into treatment and control groups in a ratio of 1:1.

Patients will be randomized upon enrollment using computer generated random assignment. Treatment group will be put on activity tracker device (Fitbit Zip) with automatic step counts feedback throughout the study. Meanwhile, control group will be put on same activity tracker without automatic feedback for same duration of intervention. The Fitbit Zip tracker (Fitbit Inc, San Francisco, California USA) is a validated commercially available activity tracker and its use has been proven accurate in elderly patients.

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.

At the end of the intervention, all the data will be retrieved from the Fitbit Zip via Fitbit Connect software 2.0. On top of that, data on patients' demographic, types of operation, operative findings, length of hospital stay and postoperative complication will also be recorded in case report form.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Sarawak
    • Kuching, Sarawak, Malaysia, 93586
      • Recruiting
      • Sarawak General Hospital
      • Contact: Wong Koh Ging, MD; Phone Number: 082276666; Email: kohging@ummc.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; 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; 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.
Sham Comparator: Control Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative mobility measured by mean step counts	Comparing mean step counts between treatment and control group	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in postoperative mobility	Percentage of step counts achieved by subject post-operatively is compared with subject's baseline step counts	14 days
Effect of activity tracker with automatic feedback on length of hospital stay	Compare the length of hospital stay between the treatment group and control group	up to one month
Number of patients with post operative complications	Rate of complications related to immobilisation (deep vein thrombosis, atelectasis, pneumonia, decubitus ulcer, pulmonary embolism, bedsore) are compared between treatment and control group	up to one month

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Wong Koh Ging, MD, University Malaya

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: May 27, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 30, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 36100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No