UMIC Validation Study
Condition: Healthy
Study type: Interventional

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.
    

Detailed description: 
      The new wearable sensor- and monitoring system has to be tested on 20 healthy sportsmen of
      both genders in the age between 18 and 35 years. The aim of the present study is the
      characterisation of technical parameters, diagnostic precision and practical applicability of
      this system, which should be able to measure and translate information of actual physiologic
      state during the physical activity of sportsmen under real-life conditions.

      IPANEMA (Integrated Posture and Activity Network) is a construct consisting of electrodes and
      several specialized sensors integrated in the textile tissue of a T-Shirt and interconnected
      with "electronic nods", an equipment supporting the central computerized control system with
      information via Bluetooth signals.

      This body sensor network enables ablations of electrical activity of heart (ECG),
      Bioimpedance Spectroscopy (BIS), measuring of temperature and humidity on the surface of
      skin, breathing intensity and acceleration of body movement.

      The study is divided in 3 parts, the indoor part, the outdoor part, and the part of
      measurements under controlled artificial temperature conditions (climate chamber).

      The outdoor measurements will be performed at different running tracks, e.g. at the
      Hochschulsportzentrum, Lousberg, and can be separated in two subtypes, the training and the
      competition.

      The indoor study phase lasts ca. 2 hours, where the volunteers will be analysed during
      running on a tread mill with both, the IPANEMA system and common medical monitoring
      procedures. The evaluations of identical physiological parameters obtained by use of
      stationary diagnostic equipment, the ergospirometric device PowerCube Ergo, BIS measurement
      system Xitron Hydra 4200, infra-red camera VarioCam®hr-basic and standard medical ECG
      measurements are used as reference values. Two hours before the start and during the entire
      training phase, the experimental group is restricted to food and liquid intake in opposite to
      control group. These experimental conditions purpose to clarify several physiological effects
      of dehydration during sportive activities. The outdoor- and climate chamber- investigations
      do not prescribe the liquid deprivation.

      The climate chamber measurements will be performed in a temperature controlled room. This
      measurement session can last up to 3 hours and temperature inside of climate chamber can be
      increased until 40Cº. Such conditions may simulate body sensor network and elicit
      physiological effects comparable to effects obtained during sportive activities. No sport is
      performed by volunteers during the climate chamber phase.
    

Intervention name(s): Validation of the IPANEMA - measurement system
Intervention type(s): Device
Intervention description(s): Control of the body conditions under real life conditions during a sportive activity.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: heart rate; sweating; respiration; acceleration of body movement; heart activity.