Trial document




drksid header

  DRKS00005301

Trial Description

start of 1:1-Block title

Title

Noninvasive determination of total body water during sports

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Noninvasive hydration markers are continuously collected during a two-hour endurance run. The markers are used to develop pattern recognition algorithms that should be able to estimate total body water during sports and recognize dehydrations.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The study continuously collects invasive and noninvasive hydration markers during a two-hour endurance run. The noninvasive hydration markers are used to develop pattern recognition algorithms that should be able to estimate total body water during sports and recognize dehydrations. The invasive hydration markers are used as ground truth for the validation of pattern recognition algorithms.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005301
  •   2013/09/16
  •   [---]*
  •   yes
  •   Approved
  •   107_13 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E86 -  Volume depletion
  •   Healthy Volunteers
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   All subjects are running on a treadmill for two hours in order to generate a slowly increasing dehydration. Measurements are collected every 15 minutes.

    Ground truth of total body water is measured via the combination of D2O dilution (deuterium oxide) and monitoring of body weight.

    Several noninvasive measurements are collected:
    - anthropometric measurements (e.g. age, height, length and perimeter of individual body parts)
    - bioimpedance
    - saliva: flow rate, protein concentration, osmolality
    - sweat: flow rate, concentration of chloride, sodium and potassium, osmolality
    - heart rate
    - blood pressure
    - core temperature
    - skin temperature
    - skin moisture
    - body volume
    - subjects' own perception of thirst and fatigue


end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

There are no primary or secondary outcomes. The study is conducted to collected data for the development of pattern recognition algorithms.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

There are no primary or secondary outcomes. The study is conducted to collected data for the development of pattern recognition algorithms.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/09/10
  •   10
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   18   Years
  •   35   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

All subjects have to be healthy, do sports on a regular basis, have a social security number, and pass a performance diagnostics test.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Pre-existing disease of heart or other cardiovascular diseases
- medical history, acute or chronic diseases that could influence the results or could worsen
- blood laboratory findings that are outside of laboratory standards

- If the performance diagnostics test could not be performed because of one or more of the following contra indicators:
- acute coronary syndrome
- symptomatical cardiac irregularity and/or restricted hemodynamics
- symptomatical severe aortic stenosis
- congestive cardiac insufficiency
- acute pulmonary embolism
- acute carditis
- acute aortic dissection
- feverish infections
- phlebothrombosis of lower extremities
- main (coronary artery) stenosis
- valvular heart disease of moderate degree
- known electrolyte disorder
- arterial hypertonia (RR > 180/100 mmHg)
- tachyarrhythmia or bradyarrhythmia
- hypertrophic obstructive cardiomyopathy
- high-grade AV-block
- anemia
- physical and/or psychological impairments

Further exclusion criteria that could occur during the performance diagnostics test:
- RR systolic > 230-260 mmHg, diastolic > 115 mmHg
- supraventricular tachycardia
- bradyarrhythmia
- polymorphic extrasystole and salvos
- high-grade AV-block, bundle branch block
- angina pectoris
- major dyspnea, vertigo
- major, typical ST depression (V4-6 > 0,3 mV, Extr. > 0,2 mV)
- significant ST elevation (DGK: > 0,1 mV)
- indicator of myocardial ischaemia
- cyanosis

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Pattern Recognition Lab, Friedrich-Alexander-University Erlangen-Nuremberg
    • 91058  Erlangen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Pattern Recognition Lab, Friedrich-Alexander-University Erlangen-Nuremberg
    • Matthias  Ring 
    • Haberstraße 2
    • 91058  Erlangen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Pattern Recognition Lab, Friedrich-Alexander-University Erlangen-Nuremberg
    • Matthias  Ring 
    • Haberstraße 2
    • 91058  Erlangen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Telekom Stiftung
    • 53262  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Pattern Recognition Lab, Friedrich-Alexander-University Erlangen-Nuremberg
    • 91058  Erlangen
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2014/02/21
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.