Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia (NCT01135888) | Clinical Trial Compass
CompletedNot Applicable
Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia
Germany28 participantsStarted 2009-04
Plain-language 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.
Who can participate
Age range
7 Years – 18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial specifically studied how physical exercise affects body temperature in people with X-linked hypohidrotic ectodermal dysplasia, what did the results show about the actual temperature risks my child or I might face during exercise?
2Because people with hypohidrotic ectodermal dysplasia have reduced sweating ability, what safe cooling strategies or precautions does this research suggest we should have in place before any physical activity?
3This trial is now completed — does my doctor know of any published findings from it that would help us set practical guidelines for how much exercise is safe and at what temperatures?
4Given that this was a short-term study on exercise risks rather than a long-term treatment trial, are there follow-up studies or clinical guidelines based on this research that my care team is already using?
5Since overheating during exercise is a known danger with this condition, how should we use what was learned in this trial to create an emergency plan if my body temperature rises too quickly during physical activity?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.