Generation of Prediction Equations for BIA of the Elderly
NCT ID: NCT04028648
Last Updated: 2022-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
150 participants
OBSERVATIONAL
2019-01-22
2020-01-08
Brief Summary
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Multi-frequency bioimpedance is measured for all body segments: right arm, left arm, right leg, left leg, trunk, right body side and left body side using the seca mBCA 515 in standing position and the seca mBCA 525 in standing and lying position.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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elderly
150 elderlies (\>60 years): community dwelling or living in old
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* stable medication (no changes during the past 6 months),
* subjects need to be able to sign the informed consent and privacy policy
Exclusion Criteria
* intake of diuretics
* wearing of support stockings
* edema diagnosed by inspection and palpation of lower limbs
* paralysis e.g. after a stroke
* neurodegenerative diseases e.g. ALS
* tumors in treatment
* amputation
* electronic implants e.g. pacemaker
* under the skin applied injection systems (e.g. insulin pumps or pain pumps)
* probands who cannot provide an ICF by themselves
* probands who might be dependent from the sponsor or the investigation site
* current alcohol abuse
* active prostheses
* electronic life-support systems, e.g. artificial heart, artificial lung
* portable electronic medical devices, e.g. ECG devices or infusion pumps
* metallic implants
* cochlea implants und heart valves prothesis (e.g. Starr-Edwards-Prothesis)
* vessel clips in the brain or medulla applied before 1995
* defeatable pumps
* catheter
* iron or metallic parts in the body (e.g. shard of metal)
* dental braces
* magnetic tooth implants
* not removeable piercings
* extensive tattoos
60 Years
ALL
Yes
Sponsors
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Seca GmbH & Co. Kg.
INDUSTRY
Responsible Party
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Locations
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Institute of Human Nutrition and Food Science
Kiel, , Germany
Countries
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References
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Enderle J, Reljic D, Jensen B, Peine S, Zopf Y, Bosy-Westphal A. Normal values for body composition in adults are better represented by continuous reference ranges dependent on age and BMI. Clin Nutr. 2023 May;42(5):644-652. doi: 10.1016/j.clnu.2023.03.006. Epub 2023 Mar 9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BCA-12
Identifier Type: -
Identifier Source: org_study_id
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