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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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X-Linked Hypohidrotic Ectodermal Dysplasia Exercise-induced Rise of Body Temperature

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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HED children

No interventions assigned to this group

HED adolescents

Skin cooling devices

Intervention Type DEVICE

Cooling vest and cooling bandana

Control children

No interventions assigned to this group

Control adolescents

Skin cooling devices

Intervention Type DEVICE

Cooling vest and cooling bandana

Interventions

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Skin cooling devices

Cooling vest and cooling bandana

Intervention Type DEVICE

Other Intervention Names

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Cooline

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes