- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03815708
Heat Stress in Wheelchair Sports
March 10, 2023 updated by: Swiss Paraplegic Centre Nottwil
Heat Stress During Wheelchair Rugby and Basketball
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.
Study Overview
Status
Completed
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.
Study Type
Observational
Enrollment (Actual)
16
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Claudio Perret, PD Dr.
- Phone Number: +41419396621
- Email: claudio.perret@paraplegie.ch
Study Contact Backup
- Name: Fabian Grossmann
- Phone Number: +41419396615
- Email: fabian.grossmann@paraplegie.ch
Study Locations
-
-
Lucerne
-
Nottwil, Lucerne, Switzerland, 6207
- Swiss Paraplegic Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
well trained spinal cord injured wheelchair rugby and basketball players
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
wheelchair rugby players
well-trained spinal cord injured wheelchair rugby players
|
wheelchair basketball players
well-trained spinal cord injured wheelchair basketball players
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body core temperature
Time Frame: from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in heart rate
Time Frame: from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)
|
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)
|
covered distance
Time Frame: 32 minutes (cohort 1) or 48 minutes (cohort 2)
|
covered distance (meters) during a rugby or basketball game
|
32 minutes (cohort 1) or 48 minutes (cohort 2)
|
Change in body weight
Time Frame: 32 minutes (cohort 1) or 48 minutes (cohort 2)
|
difference in weight (kg) from before to after the game due to sweating and convection
|
32 minutes (cohort 1) or 48 minutes (cohort 2)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Claudio Perret, PD Dr., Swiss Paraplegic Centre, Guido A. Zäch Strasse 1, CH-6207 Nottwil
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2018
Primary Completion (Actual)
August 31, 2022
Study Completion (Actual)
August 31, 2022
Study Registration Dates
First Submitted
December 10, 2018
First Submitted That Met QC Criteria
January 23, 2019
First Posted (Actual)
January 24, 2019
Study Record Updates
Last Update Posted (Actual)
March 13, 2023
Last Update Submitted That Met QC Criteria
March 10, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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