NCT07831109

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

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

First Submitted

Initial submission to the registry

October 10, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 9, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

Same day

First QC Date

October 10, 2024

Last Update Submit

September 15, 2026

Conditions

Keywords

Trail runningPsychological responsesPhysiological responsesBiomechanical responsesHot and humid environment

Outcome Measures

Primary Outcomes (12)

  • 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).

    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).

    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)

    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)

    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)

    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)

    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

    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

    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

    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

    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

    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

    11 measurements, before the start and after each ascent and each descent; between 30 minutes and 1hour and 30minutes

Study Arms (1)

Trail Running

EXPERIMENTAL

Trail running of 28km with 2580m vertical drop

Other: Trail running of 28km and 2580m vertical drop

Interventions

Running 5 round trip, up and down a hill of 2.8km each and 516m vertical drop

Trail Running

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Réunion

Saint-Denis, France, 97400, Reunion

Location

Study Officials

  • Nicolas Bouscaren, MD

    CHU La Réunion

    PRINCIPAL INVESTIGATOR
  • Bertrand Baron, PhD

    Universite de La Reunion

    STUDY DIRECTOR
  • Alain Groslambert, PhD

    Université de Bourgogne Franche-Comté

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2024

First Posted

September 21, 2026

Study Start

November 9, 2024

Primary Completion

November 9, 2024

Study Completion

November 15, 2024

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations