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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03815708
Other study ID # 2018-24
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date August 31, 2022

Study information

Verified date March 2023
Source Swiss Paraplegic Centre Nottwil
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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-CelsiusĀ® device

Study Design


Locations

Country Name City State
Switzerland Swiss Paraplegic Centre Nottwil Lucerne

Sponsors (1)

Lead Sponsor Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in body core temperature recording body core temperature with an electronic capsule from the beginning to the end of a rugby or basketball game from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)
Secondary Change in heart rate heart rate from the beginning to the end of a rugby or basketball game from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)
Secondary covered distance covered distance (meters) during a rugby or basketball game 32 minutes (cohort 1) or 48 minutes (cohort 2)
Secondary Change in body weight difference in weight (kg) from before to after the game due to sweating and convection 32 minutes (cohort 1) or 48 minutes (cohort 2)
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