NCT03815708

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

3.8 years

First QC Date

December 10, 2018

Last Update Submit

March 10, 2023

Conditions

Outcome Measures

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

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

Secondary Outcomes (3)

  • Change in heart rate

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

  • covered distance

    32 minutes (cohort 1) or 48 minutes (cohort 2)

  • Change in body weight

    32 minutes (cohort 1) or 48 minutes (cohort 2)

Study Arms (2)

wheelchair rugby players

well-trained spinal cord injured wheelchair rugby players

wheelchair basketball players

well-trained spinal cord injured wheelchair basketball players

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

well trained spinal cord injured wheelchair rugby and basketball players

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Heat Stress DisordersBody Temperature Changes

Condition Hierarchy (Ancestors)

Wounds and InjuriesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Claudio Perret, PD Dr.

    Swiss Paraplegic Centre, Guido A. Zäch Strasse 1, CH-6207 Nottwil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2018

First Posted

January 24, 2019

Study Start

November 1, 2018

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

March 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations