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Wearable Bioimpedance Analyzer for Tracking Body Composition Changes

Primary Purpose

Obesity, Knee Osteoarthritis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
InBody Band 2
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring total knee replacement, obesity, total joint replacement, bioimpedance, orthopedics, body composition, fitness tracker

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults >/= 18 years BMI > 40kg/m2 Presenting to arthroplasty-obesity clinic with desire for total joint arthroplasty procedure Owns a smartphone capable of handling iOS or Google Play apps. Exclusion Criteria: Has a pacemaker or other electronic pacemaker placement Inability to complete study protocols Inability to stand unsupported for 60-90 seconds Does not own a smart phone

Sites / Locations

  • University of Iowa Hospitals & Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Wearable Device Group

Control Group

Arm Description

Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.

Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.

Outcomes

Primary Outcome Measures

Rate of body composition changes
To identify if the use of a wearable BIA wristband has any effect on the rate of desired body composition changes.

Secondary Outcome Measures

Surgical Outcomes
Incidence of complications in surgical outcomes for patients across both groups that achieve obtaining surgical indication.
Body composition changes quantified
Body mass change, fat mass change, skeletal muscle mass change

Full Information

First Posted
May 3, 2023
Last Updated
August 14, 2023
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT05986617
Brief Title
Wearable Bioimpedance Analyzer for Tracking Body Composition Changes
Official Title
Wearable Bioimpedance Analyzer for Tracking Body Composition Changes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Obesity, namely at body mass index (BMI) levels exceeding 40kg/m2 (class III obesity), is a risk factor for many diseases including osteoarthritis (OA). In arthroplasty, patients in this population frequently present for and are turned away from surgical intervention. Subsequently, efforts are made to decrease BMI through simple weight loss, yet these have been suggested as ineffective and counterproductive. Furthermore, simple weight loss may include muscle mass loss, which is an additional risk factor for surgery. At the University of Iowa Hospitals and Clinics Orthopedics Department, efforts have been made to encourage muscle mass gain and body fat loss over simple weight loss where progress has been tracked through stationary, multi-frequency bioimpedance analysis (BIA). BIA is a readily available technology offered to industry and consumers, and BIA has recently been incorporated into wearable devices. In the UIHC Orthopedics department, a novel clinic aimed at holistically serving the osteoarthritic-class III obese population for controlled and monitored weight loss through BIA. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Knee Osteoarthritis
Keywords
total knee replacement, obesity, total joint replacement, bioimpedance, orthopedics, body composition, fitness tracker

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wearable Device Group
Arm Type
Experimental
Arm Description
Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
Intervention Type
Device
Intervention Name(s)
InBody Band 2
Intervention Description
Wearable bioimpediance monitor similar to a fitness watch.
Primary Outcome Measure Information:
Title
Rate of body composition changes
Description
To identify if the use of a wearable BIA wristband has any effect on the rate of desired body composition changes.
Time Frame
Maximum 12 months prior to TJA
Secondary Outcome Measure Information:
Title
Surgical Outcomes
Description
Incidence of complications in surgical outcomes for patients across both groups that achieve obtaining surgical indication.
Time Frame
24 months postoperatively
Title
Body composition changes quantified
Description
Body mass change, fat mass change, skeletal muscle mass change
Time Frame
Maximum 12 months prior to TJA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults >/= 18 years BMI > 40kg/m2 Presenting to arthroplasty-obesity clinic with desire for total joint arthroplasty procedure Owns a smartphone capable of handling iOS or Google Play apps. Exclusion Criteria: Has a pacemaker or other electronic pacemaker placement Inability to complete study protocols Inability to stand unsupported for 60-90 seconds Does not own a smart phone
Facility Information:
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11234459
Citation
Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
Results Reference
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PubMed Identifier
23518425
Citation
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.
Results Reference
background
PubMed Identifier
18378913
Citation
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.
Results Reference
background
PubMed Identifier
29631859
Citation
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.
Results Reference
background
PubMed Identifier
31530460
Citation
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.
Results Reference
background
PubMed Identifier
24018161
Citation
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.
Results Reference
background
PubMed Identifier
24788497
Citation
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.
Results Reference
background
PubMed Identifier
23670675
Citation
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.
Results Reference
background
PubMed Identifier
17679047
Citation
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.
Results Reference
background
PubMed Identifier
29725746
Citation
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.
Results Reference
background
PubMed Identifier
20221834
Citation
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.
Results Reference
background
PubMed Identifier
23188719
Citation
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.
Results Reference
background
PubMed Identifier
31515193
Citation
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.
Results Reference
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Wearable Bioimpedance Analyzer for Tracking Body Composition Changes

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