Wearable Bioimpedance Analyzer for Tracking Body Composition Changes
NCT ID: NCT05986617
Last Updated: 2024-12-17
Study Results
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View full resultsBasic Information
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TERMINATED
NA
60 participants
INTERVENTIONAL
2023-07-14
2024-10-08
Brief Summary
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This study, a randomized controlled trial, aims to recruit adult patients with class III obesity presenting to the arthroplasty-obesity clinic. While all patients will receive individual body composition coaching to increase muscle mass and decrease body fat mass, they will be randomized to one of two cohorts: the study group will receive a wearable BIA wristband (InBody BAND 2) and instruction on its use in addition to the standard coaching, and the control group will only receive the standard coaching.
This study aims to identify if the use of a wearable BIA wristband aids in the desired body composition changes. In addition, this study aims to quantify the body composition changes exhibited by each cohort. Finally, this study aims to track surgical outcomes for those patients that are indicated for total joint arthroplasty.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Wearable Device Group
Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
InBody Band 2
Wearable bioimpediance monitor similar to a fitness watch.
Control Group
Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
No interventions assigned to this group
Interventions
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InBody Band 2
Wearable bioimpediance monitor similar to a fitness watch.
Eligibility Criteria
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Inclusion Criteria
* BMI \> 40kg/m2
* Presenting to bariatric arthroplasty clinic with desire for total joint arthroplasty procedure
* Owns a smartphone capable of handling iOS or Google Play apps
* Has a wrist circumference less than or equal to 7.7"
Exclusion Criteria
* Inability to complete study protocols
* Inability to stand unsupported for 60-90 seconds
* Does not own a smart phone capable of handling iOS or Google Play apps
* Has a wrist circumference greater than 7.7"
18 Years
99 Years
ALL
No
Sponsors
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University of Iowa
OTHER
Responsible Party
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Jacob M. Elkins
Assistant Professor of Orthopedics and Rehabilitation
Principal Investigators
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Jacob Elkins, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Countries
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References
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Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
Workgroup of the American Association of Hip and Knee Surgeons Evidence Based Committee. Obesity and total joint arthroplasty: a literature based review. J Arthroplasty. 2013 May;28(5):714-21. doi: 10.1016/j.arth.2013.02.011. Epub 2013 Mar 19.
Andrew JG, Palan J, Kurup HV, Gibson P, Murray DW, Beard DJ. Obesity in total hip replacement. J Bone Joint Surg Br. 2008 Apr;90(4):424-9. doi: 10.1302/0301-620X.90B4.20522.
DeMik DE, Bedard NA, Dowdle SB, Elkins JM, Brown TS, Gao Y, Callaghan JJ. Complications and Obesity in Arthroplasty-A Hip is Not a Knee. J Arthroplasty. 2018 Oct;33(10):3281-3287. doi: 10.1016/j.arth.2018.02.073. Epub 2018 Feb 26.
Foreman CW, Callaghan JJ, Brown TS, Elkins JM, Otero JE. Total Joint Arthroplasty in the Morbidly Obese: How Body Mass Index >/=40 Influences Patient Retention, Treatment Decisions, and Treatment Outcomes. J Arthroplasty. 2020 Jan;35(1):39-44. doi: 10.1016/j.arth.2019.08.019. Epub 2019 Aug 17.
Inacio MC, Kritz-Silverstein D, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian DC. The impact of pre-operative weight loss on incidence of surgical site infection and readmission rates after total joint arthroplasty. J Arthroplasty. 2014 Mar;29(3):458-64.e1. doi: 10.1016/j.arth.2013.07.030. Epub 2013 Sep 7.
Inacio MC, Kritz-Silverstein D, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian DC. The risk of surgical site infection and re-admission in obese patients undergoing total joint replacement who lose weight before surgery and keep it off post-operatively. Bone Joint J. 2014 May;96-B(5):629-35. doi: 10.1302/0301-620X.96B5.33136.
Friedman RJ, Hess S, Berkowitz SD, Homering M. Complication rates after hip or knee arthroplasty in morbidly obese patients. Clin Orthop Relat Res. 2013 Oct;471(10):3358-66. doi: 10.1007/s11999-013-3049-9. Epub 2013 May 14.
Ward LC, Dyer JM, Byrne NM, Sharpe KK, Hills AP. Validation of a three-frequency bioimpedance spectroscopic method for body composition analysis. Nutrition. 2007 Sep;23(9):657-64. doi: 10.1016/j.nut.2007.06.009.
Milone MT, Shenoy K, Pham H, Jazrawi LM, Strauss EJ. MRI analysis of peripheral soft tissue composition, not body mass index, correlates with outcomes following anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2018 Dec;26(12):3711-3716. doi: 10.1007/s00167-018-4966-7. Epub 2018 May 3.
Muller M, Tohtz S, Winkler T, Dewey M, Springer I, Perka C. MRI findings of gluteus minimus muscle damage in primary total hip arthroplasty and the influence on clinical outcome. Arch Orthop Trauma Surg. 2010 Jul;130(7):927-35. doi: 10.1007/s00402-010-1085-4. Epub 2010 Mar 11.
Pichonnaz C, Bassin JP, Currat D, Martin E, Jolles BM. Bioimpedance for oedema evaluation after total knee arthroplasty. Physiother Res Int. 2013 Sep;18(3):140-7. doi: 10.1002/pri.1540. Epub 2012 Nov 27.
Qin ES, Bowen MJ, James SL, Chen WF. Multi-segment bioimpedance can assess patients with bilateral lymphedema. J Plast Reconstr Aesthet Surg. 2020 Feb;73(2):328-336. doi: 10.1016/j.bjps.2019.06.041. Epub 2019 Aug 7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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202207288
Identifier Type: -
Identifier Source: org_study_id