Use of Wearable Activity Tracker in Elderly Undergoing Abdominal Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03175783
• Other study ID #: 36100
• Status: Recruiting
• Phase: N/A
• First received: May 27, 2017
• Last updated: July 30, 2017
• Start date: July 1, 2017
• Est. completion date: June 2018

Study information

• Verified date: July 2017
• Source: University of Malaya
• Contact: Wong Koh Ging, MD
• Phone: 082276666
• Email: kohging[@]ummc.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
Malaysia	Sarawak General Hospital	Kuching	Sarawak

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (7)

Appelboom G, Taylor BE, Bruce E, Bassile CC, Malakidis C, Yang A, Youngerman B, D'Amico R, Bruce S, Bruyère 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. — View Citation

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. — View Citation

Dupont WD, Plummer WD Jr. Power and sample size calculations for studies involving linear regression. Control Clin Trials. 1998 Dec;19(6):589-601. — View Citation

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. — View Citation

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. eCollection 2015. — View Citation

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. — View Citation

Wolk S, Meißner T, Linke S, Müssle 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative mobility measured by mean step counts	Comparing mean step counts between treatment and control group	14 days
Secondary	Percent change in postoperative mobility	Percentage of step counts achieved by subject post-operatively is compared with subject's baseline step counts	14 days
Secondary	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
Secondary	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