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Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia

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ClinicalTrials.gov Identifier: NCT01135888
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : July 27, 2011
Sponsor:
Collaborator:
Pervormance GmbH
Information provided by:
University Hospital Erlangen

Study Description
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Brief Summary:
Because of their lack of sweat glands individuals with hypohidrotic ectodermal dysplasia (HED) are at particular risk of life-threatening hyperthermia during exercise in a warm environment. In this study, the effects of physical exercise are investigated in boys and male adolescents with X-chromosomally inherited HED as well as age-matched controls, who undergo standardized exertion on a bicycle ergometer at ambient temperatures of 25°C and 30°C. Body core temperature during and after ergometry, heart rate, performance, and serum lactate as a marker of metabolic stress are measured. Subjects with HED are expected to show an endangering rise of body temperature in connection with physical exercise. To clarify, whether novel cooling devices may reduce the likelihood of overheating, the effects of such devices are evaluated at 30°C.

Condition or disease Intervention/treatment
X-Linked Hypohidrotic Ectodermal Dysplasia Exercise-induced Rise of Body Temperature Device: Skin cooling devices

Study Design
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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia (Christ-Siemens-Touraine Syndrome)
Study Start Date : April 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
HED children
HED adolescents Device: Skin cooling devices
Cooling vest and cooling bandana
Other Name: Cooline
Control children
Control adolescents Device: Skin cooling devices
Cooling vest and cooling bandana
Other Name: Cooline


Outcome Measures
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Biospecimen Retention:   Samples Without DNA
Serum

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
subjects with X-chromosomally inherited hypohidrotic ectodermal dysplasia (HED) and age-matched controls
Criteria

Inclusion Criteria:

  • for patients: hypohidrotic ectodermal dysplasia caused by EDA gene mutations
  • regular fluid intake prior to the investigation
  • written informed consent

Exclusion Criteria:

  • acute febrile illness
  • acute or chronic heart disease
  • arterial hypertension
  • gastrointestinal disorders
  • implantable electronic devices
  • MRI investigation scheduled for the 5 days subsequent to the study
  • clinical signs or diagnostic findings of dehydration
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135888


Locations
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Germany
University Hospital Erlangen
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University Hospital Erlangen
Pervormance GmbH
Investigators
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Principal Investigator: Holm Schneider, MD University Hospital Erlangen
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Holm Schneider, MD / Professor of Pediatrics, Head of the Division of Molecular Pediatrics, University Hospital Erlangen
ClinicalTrials.gov Identifier: NCT01135888    
Other Study ID Numbers: ED09
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: July 27, 2011
Last Verified: July 2011
Keywords provided by University Hospital Erlangen:
hypohidrotic ectodermal dysplasia
exertional hyperthermia
cooling device
Additional relevant MeSH terms:
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Ectodermal Dysplasia
Ectodermal Dysplasia 1, Anhidrotic
Hyperplasia
Pathologic Processes
Abnormalities, Multiple
Congenital Abnormalities
 Skin Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Genetic Diseases, X-Linked