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Thermoregulatory responses of patients with EHS or MHS compared with healthy controls

Thermoregulatory responses of patients with EHS or MHS compared with healthy controls - THREM study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51224
Enrollment
45
Registered
2021-02-15
Start date
2021-05-28
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thermoregulatoire aandoeningen (hitteberoerte en maligne hyperthermie) excessive hyperthermia Heat stroke

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Between 18 and 60 years of age - Willingness to provide written consent after proper information about the study objectives and procedures - Physically active lifestyle (endurance exercise, *2 times a week) Furthermore, we will apply specific inclusion criteria for the EHS and MHS group. - EHS group: a history of an EHS in the past 10 years that has resulted in physical complaints for at least 6 months. - MH group: a history of RYR1-related MH or MH susceptibility (MHS) according to the guidelines of the European Malignant Hyperthermia Group (EMHG), which states that an individual is MHS when an individual have a diagnostically confirmed RYR1 variant or a positive in vitro contracture test. Only one member per family will be included in order to ensure that we include a representative sample of the MHS population. - Control group: healthy age and sex matched peers.

Exclusion criteria

Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: - Exclusion criteria associated with the use of the telemetric temperature capsule: I) a bodyweight

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is the increase in core temperature (CBT) during exercise at a fixed metabolic heat production.

Secondary

MeasureTime frame
Secondary outcomes relate to the thermoregulatory (i.e. skin temperature, heat production, sweat rate, heat balance) and cardiovascular responses (i.e. heart rate, blood pressure) to exercise in hot environmental conditions.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)