Heat StressNCT03815708
Heat Stress in Wheelchair Sports
An observational study of Heat Stress and Body Temperature Changes, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Heat Stress, Body Temperature Changes
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2018to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: well trained spinal cord injured wheelchair rugby and basketball players
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: 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.
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.
- Conditions
- Heat Stress, Body Temperature Changes
- Medical subject headings
- Heat Stress Disorders, Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| wheelchair rugby players | well-trained spinal cord injured wheelchair rugby players | |
| wheelchair basketball players | well-trained spinal cord injured wheelchair basketball players |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)
Secondary outcomes (3)
Change in heart rate
heart rate from the beginning to the end of a rugby or basketball game
Measured: from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)
covered distance
covered distance (meters) during a rugby or basketball game
Measured: 32 minutes (cohort 1) or 48 minutes (cohort 2)
Change in body weight
difference in weight (kg) from before to after the game due to sweating and convection
Measured: 32 minutes (cohort 1) or 48 minutes (cohort 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Nov 2018
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Claudio Perret, PD Dr., Principal investigator, Swiss Paraplegic Centre, Guido A. Zäch Strasse 1, CH-6207 Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815708
- Sponsor's protocol ID
- 2018-24
- Status last verified
- Mar 2023
- First submitted
- 10 Dec 2018
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Stress During Wheelchair Rugby and Basketball
- ClinicalTrials.gov ID
- NCT03815708
- Acronym / sponsor ID
- 2018-24
- Conditions
- Heat Stress, Body Temperature Changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wheelchair rugby players | – | –well-trained spinal cord injured wheelchair rugby players |
| wheelchair basketball players | – | –well-trained spinal cord injured wheelchair basketball players |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- well trained spinal cord injured wheelchair rugby and basketball players
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Change in heart rate
Time frame: 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)
Change in body weight
Time frame: 32 minutes (cohort 1) or 48 minutes (cohort 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Perret, PD Dr. principal investigator
Swiss Paraplegic Centre, Guido A. Zäch Strasse 1, CH-6207 Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heat Stress and Body Temperature Changes, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body core temperature (time frame: from 0 minutes to 32 minutes (cohort 1) or 48 minutes (cohort 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.