UMIC Validation Study
Ultra High Speed Mobile Information and Communication
2 other identifiers
interventional
12
1 country
1
Brief Summary
The purpose of the study is to evaluate the feasibility of a new wearable computerised system designed for an ongoing monitoring of sportsmen under real-life conditions. This system consists of different sensors and Bluetooth Transmitters interconnected by wires and integrated in the textile of a T-shirt. Several physiologic parameters including bioimpedance should be investigated under conditions relevant for an intensive physical activity, like high body temperature or partial dehydration. This system has to be tested under laboratory and "natural/open air" conditions, the obtained evaluations compared with standardised established diagnostic methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 28, 2012
CompletedFirst Posted
Study publicly available on registry
October 17, 2012
CompletedNovember 14, 2012
November 1, 2012
8 months
September 28, 2012
November 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determination of vital signs out of a portable measuring system for monitoring performance of athletes during exercise
Validation of a new portable und functional sensor based monitoring system.
ten measurements each three hours
Secondary Outcomes (1)
Determination of vital signs out of a new textile integrated and portable measurement system during training and competition conditions in comparision to parallel measurements with the reference devices
ten measurements each three hours
Study Arms (2)
IPANEMA validation without water intake
EXPERIMENTALThe one group is restricted to the water intake during the Indoor phase during testing the IPANEMA measurement system. The other group is not restricted to the water intake.
IPANEMA validation with water intake
EXPERIMENTALThe one group is restricted to the water intake during the Indoor phase, the other group is not restricted to the water intake.
Interventions
Control of the body conditions under real life conditions during a sportive activity.
Eligibility Criteria
You may qualify if:
- healthy, sporty person
- age 18-35 years
- able to give informed consent
You may not qualify if:
- electrophobics
- metallic and / or electric implants
- balance difficulties
- cardiac insufficiency
- arterial hypotension
- truncal ataxia
- underage persons
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Internal Medicine I, University Hospital
Aachen, North Rhine-Westphalia, 52074, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Krüger, Univ.-Prof.
Internal Medicine I, University Hospital Aachen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2012
First Posted
October 17, 2012
Study Start
July 1, 2011
Primary Completion
March 1, 2012
Study Completion
May 1, 2012
Last Updated
November 14, 2012
Record last verified: 2012-11