Clinical trial NCT03815708: Heat Stress in Wheelchair Sports
Official title: Heat Stress During Wheelchair Rugby and Basketball
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heat Stress
Body Temperature Changes
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2019-01-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: well trained spinal cord injured wheelchair rugby and basketball players

Brief summary: The aim of the study is to study the thermoregulatory responses under real life conditions, such as during wheelchair rugby and basketball matches. A further goal is to develop and validate a standardised field-based protocol, which induces the same thermoregulatory response as during a wheelchair rugby and basketball match. This knowledge allows to investigate strategies to reduce heat stress and to enhance exercise performance (e.g. pre-cooling) in the future, based on standardised conditions.

Detailed description: A spinal cord injury leads to several physiological changes and complications, which might influence exercise performance (Perret and Abel, 2016). One major problem is the limited thermoregulation, especially in subjects suffering from a tetraplegia (Griggs et al., 2015; Price et al., 2006). There are only few studies, which investigated the thermoregulatory response during real life conditions in wheelchair athletes such as during a wheelchair rugby match (Griggs et al., 2017). However, to implement strategies to reduce heat stress (e.g. precooling methods) or to determine the influence of heat stress on exercise performance and to determine the effects of specific interventions the following two issues seem to be a prerequisite: First of all, we need to understand, which thermoregulatory response is induced under real life conditions, e.g. by a wheelchair rugby or basketball match. Second, if we want to study the effects of potential interventions, a standardised and reliable study protocol has to be available, which closely mimics match conditions and induces a similar amount of heat stress. Thus, the aim of the study is to measure thermoregulatory and physical performance outcomes during a real life wheelchair rugby and basketball match. A further goal is to develop and validate a standardised field-based protocol, which induces a similar thermoregulatory response as during a wheelchair rugby or basketball match. These knowledge builds the basis for future thermoregulatory studies based on a reliable and standardised field-based testing protocol.

Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature
* healthy, male or female wheelchair rugby (with tetraplegia) or basketball player (with paraplegia) of national or international level
* regularly taking part in competitions/games
* age between 18 and 60 years

Exclusion Criteria:

* asthma
* blood disorders
* actual injury, which impairs performance or other impossibility to exercise to exhaustion
* cardiovascular disease
* gastrointestinal disease, disorder or former surgery concerning the gastrointestinal tract
* not able to swallow a capsule
* less than 40kg of body mass
* MRI during the period of use of the e-Celsius® device

Primary outcomes:
measure: Change in body core temperature
timeFrame: from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)
Secondary outcomes:
measure: Change in heart rate
timeFrame: from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)
measure: covered distance
timeFrame: 32 minutes (cohort 1) or 48 minutes (cohort 2)
measure: Change in body weight
timeFrame: 32 minutes (cohort 1) or 48 minutes (cohort 2)
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: Lucerne
Study officials:
affiliation: Swiss Paraplegic Centre, Guido A. Zäch Strasse 1, CH-6207 Nottwil
name: Claudio Perret, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: