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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05389111
Other study ID # 38RC22.0111
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 15, 2023
Est. completion date November 2025

Study information

Verified date May 2023
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Determination of the effect of an intervention to develop the use of internal discourses on the perception of exercise during a sub-maximum effort following a trail running


Description:

The practice of mountain running or "trail" is in full development in France and elsewhere in the world. This sport practice is associated with various constraints specific to the activity. These constraints imposed on the body during the preparation, participation and recovery of this type of effort have an impact on multiple aspects of the individual (physiological, psychological, neurological...). Some studies have made it possible in each of the fields to advance the current knowledge about the trail-running environment. However, there are very few links between variables from different fields of research, even though these links are at the origin of the complex individual responses observed in the field. Therefore it seems important to study the practice of trail running and its consequences on the individual, relying on a systemic approach of the individual who studies how psychological phenomena, physiological and cerebral interactions to predict behaviour and its health consequences. The biopsychosocial models are based on this systemic approach and postulate that the perception of the individual's effort would be the main limit to the continuity of effort, performance because it causes the intensity to decrease - or even stop the effort - if this sensation becomes too strong. Consequently, the study of certain interventions aimed at reducing this perception of effort, such as the one proposed in this project, seems to be an essential step to propose to the practitioners of this type of sport strategies allowing to practice in a healthy and efficient way.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date November 2025
Est. primary completion date November 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Male or female - 18-55 years - Subjects available in Grenoble before and during the 15 days after the race - Subjects subject to a social security scheme - Subjects able to sign informed consent. - Fluent in French Exclusion Criteria: - Cardiorespiratory, metabolic and neurological conditions - People treated with anxiolytics and/or neuroleptics or ATCD for behavioural disorders - Persons refusing to sign the participation consent - Persons under guardianship - Persons referred to in Articles L1121-5 to L1121-8 of the CSP

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Internal discourses
This intervention will take place following the randomization performed at the V1 visit. It will be held in videoconference, will be led by a professional of the training field, specialist of the trail activity and trained in the use of mental strategies
Non internal discourses
This intervention will take place following the randomization performed at the V1 visit. It will be held in videoconference, and will be conducted by a professional of the training field, specialist of the trail activity and coach of mountain guide

Locations

Country Name City State
France CHU Grenoble Alpes Grenoble

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perception of effort during running. Perception of Borg scale rated effort (0 no effort; 10, maximal effort) while running on a treadmill at sub-maximum intensity 1 day
Secondary Psychological profiles of trail-running practitioners Assessement of internal discourses use, pre-competitive anxiety, self-determined motivation to practice, achievement goals assessed by a questionnaire 18 months
Secondary Perception of effort depending on running distance Comparison of the perception of effort (Borg scale rated effort (0 no effort; 10, maximal effort) while running) between subjects according to the distance of running 18 months
Secondary Link between the individual's physical level and perception of effort Correlation between VO2max assessed during exercise testing in the laboratory and effort perception 18 months
Secondary Serological library Comparison of circulating markers (e.g. BDNF, s100, creatine kinase, interleukins, to be defined a posteriori according to the physiological and cerebral effects observed) before and after the race 18 months
Secondary Performance on a cognitive task Performance on a cognitive task performed on a computer 3 months
Secondary Brain activation during a cognitive task Changes in brain oxygenation assessed by NIRS during a cognitive task 3 months
Secondary Perception of effort, attentional focus, self-efficacy and resources of self-control during a race situation Change in perception of effort, attentional focus, self-efficacy and self-monitoring resources, assessed by a questionnaire during the race 1 day
Secondary Recovery kinetics of runners after a trail race. Changes in the previous outcomes will be evaluated between the end of the race and 1-2 weeks after the race 2 weeks
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