Fitness TrackersNCT03175783
Use of Wearable Activity Tracker in Elderly Undergoing Abdominal Surgery
A study testing Fitbit Zip Activity Tracker in people with Fitness Trackers and Early Ambulation, run by University of Malaya at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fitness Trackers, Early Ambulation, Surgery
- What is being tested?
- Fitbit Zip Activity Tracker
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jul 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Sarawak General Hospital
Kuching, Sarawak, 93586
Wong Koh Ging, MD, 082276666, kohging@ummc.edu.my
About this study
Official title: 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.
Read the 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.
- Being tested
- Fitbit Zip Activity Tracker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Zip Activity TrackerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment group will receive intervention by putting on Fitbit Zip activity tracker with automatic step counts feedback throughout the study. Receives: 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. Receives: Device: Fitbit Zip Activity Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative mobility measured by mean step counts
Comparing mean step counts between treatment and control group
Measured: 14 days
Secondary outcomes (3)
Percent change in postoperative mobility
Percentage of step counts achieved by subject post-operatively is compared with subject's baseline step counts
Measured: 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
Measured: 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
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Jul 2017
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Fitness TrackersStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Wong Koh Ging, University of Malaya
- Investigators
- Wong Koh Ging, MD, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175783
- Sponsor's protocol ID
- 36100
- Status last verified
- Jul 2017
- First submitted
- 27 May 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26220691Cook 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.
PubMed 23992697van 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.
PubMed 28494785Gualtieri 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.
PubMed 27903490Paul 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.
PubMed 27900119Wolk 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.
PubMed 28222805Dupont 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.
PubMed 9875838
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Wearable Activity Tracker to Monitor and Increase Mobility for Elderly Undergoing Abdominal Surgery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03175783
- Acronym / sponsor ID
- 36100
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Fitbit Zip Activity TrackerTreatment group will receive intervention by putting on Fitbit Zip activity tracker with automatic step counts feedback throughout the study. |
| Control Group | Sham comparator | Device: Fitbit Zip Activity TrackerControl group will be put on intervention with same Fitbit Zip activity tracker but without automatic feedback for same duration of intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit Zip Activity TrackerSubjects 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. | Device | Control Group, Treatment Group |
Primary outcome
Postoperative mobility measured by mean step counts
Time frame: 14 days
Comparing mean step counts between treatment and control group
3 secondary outcomes
Percent change in postoperative mobility
Time frame: 14 days
Effect of activity tracker with automatic feedback on length of hospital stay
Time frame: up to one month
Number of patients with post operative complications
Time frame: up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Background: PubMed 26220691Appelboom 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.
- Background: PubMed 23992697Cook 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.
- Background: PubMed 28494785van 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.
- Background: PubMed 27903490Gualtieri 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.
- Background: PubMed 27900119Paul 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.
- Background: PubMed 28222805Wolk 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.
- Background: PubMed 9875838Dupont 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wong Koh Ging, MD principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Zip Activity Tracker in people with Fitness Trackers and Early Ambulation, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wong Koh Ging, MD (082276666, kohging@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative mobility measured by mean step counts (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03175783, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.