Body Temperature Changes Clinical Trial
Official title:
Heat Stress During Wheelchair Rugby and Basketball
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 |
Verified date | March 2023 |
Source | Swiss Paraplegic Centre Nottwil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Swiss Paraplegic Centre | Nottwil | Lucerne |
Lead Sponsor | Collaborator |
---|---|
Swiss Paraplegic Centre Nottwil |
Switzerland,
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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