RunningRP2B-TrailNCT07831109
Study of the Psychological, Physiological and Biomechanical Responses to Trail Running in a Hot, Humid Environment
A study testing Trail running of 28km and 2580m vertical drop in people with Running and Motivation for Physical Activity, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial summary
The determinants of trail performance have been extensively studied, and the results have revealed the significant influence of physiological, psychological and biomechanical parameters. Read more about this study
- Who is it for?
- Ages 18 months and olderHealthy volunteers can take part
- Conditions the study is for
- Running, Motivation for Physical Activity, Sport Physiology
- What is being tested?
- Trail running of 28km and 2580m vertical drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteReunion
- Study dates
- 9 Nov 2024to 15 Nov 2024
- Phase
- Interventional
- 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 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult
- Participant in trail competitions for at least 2 years.
- Affiliated or beneficiary of a social security scheme
- Have given their free, informed and written consent
- Holding a License from the French Federation of Athletism (FFA) or showing a medical certificate of no contraindication to trail running
Who cannot join
- Do not understand French
- Protected (guardianship, curatorship or under family guardianship) or placed under court protection
- Whose psychological health may, according to the investigator, affect the participant's compliance
- Have difficulty swallowing paracetamol-type capsules and will therefore have difficulty swallowing e-Celsius® Performance capsules.
Trial locations and contacts
1 site in 1 country.
About this study
The determinants of trail performance have been extensively studied, and the results have revealed the significant influence of physiological, psychological and biomechanical parameters.
Although there are numerous publications on the physiological responses of thermoregulation to exercise, the impact of heat and humidity on emotional regulation has never been studied in trail running. To the litterature, no study has looked at the evolution of biomechanical parameters during alternating ascents and descents in trail running.
No study has compared patterns of motivation between men and women during exercise, even though the hypothesis of a higher level of 'mental fitness' is put forward to explain the very high level of performance of women in long-distance events.
- Conditions
- Running, Motivation for Physical Activity, Sport Physiology
- Being tested
- Trail running of 28km and 2580m vertical drop
- Keywords
- Trail running, Psychological responses, Physiological responses, Biomechanical responses, Hot and humid environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trail running of 28km and 2580m vertical dropOther
Running 5 round trip, up and down a hill of 2.8km each and 516m vertical drop
| Study group | Role | What they receive |
|---|---|---|
| Trail Running | Experimental | Trail running of 28km with 2580m vertical drop Receives: Other: Trail running of 28km and 2580m vertical drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effort measurements
Level of effort will be measured using a scale (Borg, 1990) from 0 to 10 (0 meaning no effort, and 10 maximal effort).
Measured: 11 measurements, before the start and after each ascent and each descent, between 30 minutes and 1hour and 30 minutes
Pleasure measurements
Level of pleasure will be measured using a scale (Baron et al, 2011), from 0 to 10 (0 meaning no pleasure, and 10 maximal pleasure).
Measured: 11 measurements, before the start and after each ascent and each descent, between 30 minutes and 1hour and 30 minutes
Sensation measurements
Levels of sensation will be measured using a scale (Hardy \& Rejeski, 1989) from -5 to +5 (-5 feeling very bad; to +5 feeling very good)
Measured: 11 measurements, before the start and after each ascent and each descent, between 30 minutes and 1hour and 30 minutes
Fatigue measurements
Levels of fatigue will be measured using a scale (Brownstein et al, 2021) from 0 to 10 (0 not tired at all; to 10 total exhaustion)
Measured: 11 measurements, before the start and after each ascent and each descent, between 30 minutes and 1hour and 30minutes
Motivation measurements
Levels of motivation (5 questions) will be measured using a scale MMSE (Baron et al, 2022) from 0 to 7 (0 not motivation to 7 very motivated)
Measured: 11 measurements, before the start and after each ascent and each descent, between 30 minutes and 1hour and 30 minutes
Body temperature measurements
- Body temperature measurement in Celsius degree (Caméra FLIR E8xt, Wilsonville, Oregon, USA)
Measured: 11 measurements, before the start and after each ascent and each descent; between 30 minutes and 1hour and 30minutes
Changes in body weight
Changes in body weight measured in kilograms
Measured: 11 measurements, before the start and after each ascent and each descent; between 30 minutes and 1hour and 30 minutes
Osmolarity measurements
Salivary osmolarity will be measured using an MX3 Hydration Testing System® in nOsm
Measured: 11 measurements, before the start and after each ascent and each descent; between 30 minutes and 1hour and 30 minutes
Drop jumps measurements
Seven drop jumps
Measured: 11 measurements, before the start and after each ascent and each descent; between 30 minutes and 1hour and 30minutes
Cardiac frequency measurements
Cardiac frequency measured by heart rate monitor Performance
Measured: All the way from the start till the end of the race, measurement made automatically every 30 seconds
Central body temperature measurements
Central body temperature measured by ingested pills e-Celsius® Performance in Celsius degree
Measured: All the way from the start till the end of the race, measurement made automatically every 30 seconds
volume of water consumed
The volume of water consumed during the previous segment will be recorded in liters
Measured: 11 measurements, before the start and after each ascent and each descent; between 30 minutes and 1hour and 30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start9 Nov 2024
- Primary completion9 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RunningStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Collaborators
- Universite de La Reunion, University of Franche-Comté
- Responsible party
- Sponsor
- Investigators
- Nicolas Bouscaren, MD, Principal investigator, CHU La RéunionBertrand Baron, PhD, Study director, Universite de La ReunionAlain Groslambert, PhD, Study director, Université de Bourgogne Franche-Comté
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831109
- Sponsor's protocol ID
- 2024/CHU/40
- Acronym
- RP2B-Trail
- Status last verified
- Sep 2026
- First submitted
- 10 Oct 2024
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Psychological, Physiological and Biomechanical Responses to Trail Running in a Hot, Humid Environment
- ClinicalTrials.gov ID
- NCT07831109
- Acronym / sponsor ID
- RP2B-Trail / 2024/CHU/40
- Conditions
- Running, Motivation for Physical Activity, Sport Physiology
- Keywords
- Trail running, Psychological responses, Physiological responses, Biomechanical responses, Hot and humid environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Collaborators
- Universite de La Reunion, University of Franche-Comté
- Study start
- 9 Nov 2024 (actual)
- Primary completion
- 9 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 21 Sep 2026 (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 determinants of trail performance have been extensively studied, and the results have revealed the significant influence of physiological, psychological and biomechanical parameters.
Although there are numerous publications on the physiological responses of thermoregulation to exercise, the impact of heat and humidity on emotional regulation has never been studied in trail running. To the litterature, no study has looked at the evolution of biomechanical parameters during alternating ascents and descents in trail running.
No study has compared patterns of motivation between men and women during exercise, even though the hypothesis of a higher level of 'mental fitness' is put forward to explain the very high level of performance of women in long-distance events.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trail Running | Experimental | Other: Trail running of 28km and 2580m vertical dropTrail running of 28km with 2580m vertical drop |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adult
- Participant in trail competitions for at least 2 years.
- Affiliated or beneficiary of a social security scheme
- Have given their free, informed and written consent
- Holding a License from the French Federation of Athletism (FFA) or showing a medical certificate of no contraindication to trail running
Key exclusion criteria (4 listed)
- Do not understand French
- Protected (guardianship, curatorship or under family guardianship) or placed under court protection
- Whose psychological health may, according to the investigator, affect the participant's compliance
- Have difficulty swallowing paracetamol-type capsules and will therefore have difficulty swallowing e-Celsius® Performance capsules.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trail running of 28km and 2580m vertical dropRunning 5 round trip, up and down a hill of 2.8km each and 516m vertical drop | Other | Trail Running |
Primary outcome
Effort measurements
Time frame: 11 measurements, before the start and after each ascent and each descent, between 30 minutes and 1hour and 30 minutes
Level of effort will be measured using a scale (Borg, 1990) from 0 to 10 (0 meaning no effort, and 10 maximal effort).
Pleasure measurements
Time frame: 11 measurements, before the start and after each ascent and each descent, between 30 minutes and 1hour and 30 minutes
Level of pleasure will be measured using a scale (Baron et al, 2011), from 0 to 10 (0 meaning no pleasure, and 10 maximal pleasure).
Sensation measurements
Time frame: 11 measurements, before the start and after each ascent and each descent, between 30 minutes and 1hour and 30 minutes
Levels of sensation will be measured using a scale (Hardy \& Rejeski, 1989) from -5 to +5 (-5 feeling very bad; to +5 feeling very good)
Fatigue measurements
Time frame: 11 measurements, before the start and after each ascent and each descent, between 30 minutes and 1hour and 30minutes
Levels of fatigue will be measured using a scale (Brownstein et al, 2021) from 0 to 10 (0 not tired at all; to 10 total exhaustion)
Motivation measurements
Time frame: 11 measurements, before the start and after each ascent and each descent, between 30 minutes and 1hour and 30 minutes
Levels of motivation (5 questions) will be measured using a scale MMSE (Baron et al, 2022) from 0 to 7 (0 not motivation to 7 very motivated)
Body temperature measurements
Time frame: 11 measurements, before the start and after each ascent and each descent; between 30 minutes and 1hour and 30minutes
- Body temperature measurement in Celsius degree (Caméra FLIR E8xt, Wilsonville, Oregon, USA)
Changes in body weight
Time frame: 11 measurements, before the start and after each ascent and each descent; between 30 minutes and 1hour and 30 minutes
Changes in body weight measured in kilograms
Osmolarity measurements
Time frame: 11 measurements, before the start and after each ascent and each descent; between 30 minutes and 1hour and 30 minutes
Salivary osmolarity will be measured using an MX3 Hydration Testing System® in nOsm
Drop jumps measurements
Time frame: 11 measurements, before the start and after each ascent and each descent; between 30 minutes and 1hour and 30minutes
Seven drop jumps
Cardiac frequency measurements
Time frame: All the way from the start till the end of the race, measurement made automatically every 30 seconds
Cardiac frequency measured by heart rate monitor Performance
Central body temperature measurements
Time frame: All the way from the start till the end of the race, measurement made automatically every 30 seconds
Central body temperature measured by ingested pills e-Celsius® Performance in Celsius degree
volume of water consumed
Time frame: 11 measurements, before the start and after each ascent and each descent; between 30 minutes and 1hour and 30minutes
The volume of water consumed during the previous segment will be recorded in liters
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 21 Sep 2026.
- 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.
Nicolas Bouscaren, MD principal investigator
CHU La Réunion
Bertrand Baron, PhD study director
Universite de La Reunion
Alain Groslambert, PhD study director
Université de Bourgogne Franche-Comté
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trail running of 28km and 2580m vertical drop in people with Running and Motivation for Physical Activity, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
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 5 inclusion and 4 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 21 Sep 2026. 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 Reunion. 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?
Effort measurements (time frame: 11 measurements, before the start and after each ascent and each descent, between 30 minutes and 1hour and 30 minutes). The study lists 12 primary outcomes in all. 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 21 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.