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

Completed

• Conditions: Exercise-induced Rise of Body Temperature; X-Linked Hypohidrotic Ectodermal Dysplasia
• Interventions: Device: Skin cooling devices

• Registration Number: NCT01135888
• Lead Sponsor: University Hospital Erlangen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control adolescents	Skin cooling devices	-
HED adolescents	Skin cooling devices	-

Trial Locations

Locations (1)

University Hospital Erlangen; 🇩🇪 Erlangen, Bavaria, Germany