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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03175783 |
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Date of registration:
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27/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Use of Wearable Activity Tracker in Elderly Undergoing Abdominal Surgery
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Scientific title:
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Use of Wearable Activity Tracker to Monitor and Increase Mobility for Elderly Undergoing Abdominal Surgery: A Randomized Control Trial |
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Date of first enrolment:
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July 1, 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03175783 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Wong Koh Ging, MD |
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Address:
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Telephone:
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082276666 |
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Email:
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kohging@ummc.edu.my |
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Affiliation:
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Name:
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Wong Koh Ging, MD |
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Address:
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Telephone:
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082276666 |
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Email:
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kohging@ummc.edu.my |
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Affiliation:
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Name:
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Wong Koh Ging, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Malaya |
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Key inclusion & exclusion criteria
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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
Age minimum:
60 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Early Ambulation
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Health Services for the Aged
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Fitness Trackers
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Surgery
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Intervention(s)
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Device: Fitbit Zip Activity Tracker
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Primary Outcome(s)
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Postoperative mobility measured by mean step counts
[Time Frame: 14 days]
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Secondary Outcome(s)
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Effect of activity tracker with automatic feedback on length of hospital stay
[Time Frame: up to one month]
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Number of patients with post operative complications
[Time Frame: up to one month]
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Percent change in postoperative mobility
[Time Frame: 14 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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