ClinicalTrials.gg
CompletedNCT03815708Updated Mar 13, 2023

Heat Stress in Wheelchair Sports

An observational study in Heat Stress and Body Temperature Changes, sponsored by Swiss Paraplegic Research, Nottwil. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-13.

Sponsored by Swiss Paraplegic Research, Nottwil · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
16
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heat Stress
  • Body Temperature Changes
03

In context

Heat Stress Disorders

118 studies on the registry are indexed under Heat Stress Disorders; 45 are open to participants now.

This study's enrollment of 16 is below the median of 27 across 14 observational studies indexed under Heat Stress Disorders.

Browse Heat Stress Disorders studies →

Lead sponsor

Swiss Paraplegic Research, Nottwil is the lead sponsor of 71 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

well trained spinal cord injured wheelchair rugby and basketball players

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • wheelchair rugby players

    well-trained spinal cord injured wheelchair rugby players

  • wheelchair basketball players

    well-trained spinal cord injured wheelchair basketball players

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)

Secondary outcomes

  1. Change in heart rate

    heart rate from the beginning to the end of a rugby or basketball game

    Time frame: from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)

  2. covered distance

    covered distance (meters) during a rugby or basketball game

    Time frame: 32 minutes (cohort 1) or 48 minutes (cohort 2)

  3. Change in body weight

    difference in weight (kg) from before to after the game due to sweating and convection

    Time frame: 32 minutes (cohort 1) or 48 minutes (cohort 2)

07

Study locations

1 site
  • Swiss Paraplegic Centre
    Nottwil, Lucerne 6207, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2018 to primary completion in Aug 2022, 45 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2018
First posted
Jan 24, 2019
StartActual
Nov 1, 2018
Primary completionActual
Aug 31, 2022
CompletionActual
Aug 31, 2022
Last update
Mar 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03815708
Lead sponsor
Swiss Paraplegic Research, Nottwil
Responsible party
Sponsor
First posted
Jan 24, 2019
Start date
Nov 1, 2018
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Mar 13, 2023

Study contacts

Claudio Perret, PD Dr.
principal investigator · Swiss Paraplegic Centre, Guido A. Zäch Strasse 1, CH-6207 Nottwil

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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