Physical ExertionUT4M2022NCT05389111
Internal Discourses and Perception of Trail-running Effort
A study testing Internal discourses and Non internal discourses in people with Physical Exertion, run by University Hospital, Grenoble at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Exertion
- What is being tested?
- Internal discourses and Non internal discourses
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2023to 25 Jul 2025
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Internal Discourses on the Perception of Trail-running Effort
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
Read the detailed 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.
- Conditions
- Physical Exertion
- Being tested
- Internal discourses, Non internal discourses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal discoursesOther
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 discoursesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Internal discourses | Experimental | Introduction to internal discourses with a brief definition and key elements for implementation. Receives: Other: Internal discourses |
| Non-internal discourses | Sham comparator | Introduction to the risks associated with the practice of activity in the mountain environment and practical tips to prevent the risks Receives: Other: Non internal discourses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (8)
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
Measured: 18 months
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
Measured: 18 months
Link between the individual's physical level and perception of effort
Correlation between VO2max assessed during exercise testing in the laboratory and effort perception
Measured: 18 months
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
Measured: 18 months
Performance on a cognitive task
Performance on a cognitive task performed on a computer
Measured: 3 months
Brain activation during a cognitive task
Changes in brain oxygenation assessed by NIRS during a cognitive task
Measured: 3 months
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
Measured: 1 day
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start15 May 2023
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ExertionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389111
- Sponsor's protocol ID
- 38RC22.0111
- Acronym
- UT4M2022
- Status last verified
- Dec 2025
- First submitted
- 29 Apr 2022
- Last updated
- 30 Dec 2025
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Internal Discourses on the Perception of Trail-running Effort
- ClinicalTrials.gov ID
- NCT05389111
- Acronym / sponsor ID
- UT4M2022 / 38RC22.0111
- Conditions
- Physical Exertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 24 May 2022 (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.
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
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal discourses | Experimental | Other: Internal discoursesIntroduction to internal discourses with a brief definition and key elements for implementation. |
| Non-internal discourses | Sham comparator | Other: Non internal discoursesIntroduction to the risks associated with the practice of activity in the mountain environment and practical tips to prevent the risks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Internal discoursesThis 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 | Other | Internal discourses |
| Non internal discoursesThis 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 | Other | Non-internal discourses |
Primary outcome
Perception of effort during running.
Time frame: 1 day
Perception of Borg scale rated effort (0 no effort; 10, maximal effort) while running on a treadmill at sub-maximum intensity
8 secondary outcomes
Psychological profiles of trail-running practitioners
Time frame: 18 months
Perception of effort depending on running distance
Time frame: 18 months
Link between the individual's physical level and perception of effort
Time frame: 18 months
Serological library
Time frame: 18 months
Performance on a cognitive task
Time frame: 3 months
Brain activation during a cognitive task
Time frame: 3 months
Perception of effort, attentional focus, self-efficacy and resources of self-control during a race situation
Time frame: 1 day
Recovery kinetics of runners after a trail race.
Time frame: 2 weeks
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 30 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Physical Exertion
Not yet recruiting
Beyond Voluntary Effort: Reliability and Validity of Magnetic Femoral Nerve Stimulation for Assessing Quadriceps Strength in Critically Ill Patient
Critical Illness, ICU-acquired Weakness
RecruitingObservational study
Characterizing Perceived Physical Fatigability in Nusinersen-treated SMA
Spinal Muscular Atrophy
Not yet recruitingObservational study
Validation of 1 Minute Sit-to Stand Test for Assessment of Breathlessness at Exertion in Individuals With Chronic Lung Disease
COPD (Chronic Obstructive Pulmonary Disease), Asthma (Diagnosis)
RecruitingEarly Phase 1
Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort
Fatigue Syndrome, Chronic
Not yet recruiting
Multimodal Differences in Effort-based Decision-Making in Depression
Depression, Anhedonia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal discourses and Non internal discourses in people with Physical Exertion, run by University Hospital, Grenoble at 1 site in France.
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 6 inclusion and 5 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 30 Dec 2025. 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 France. 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. Some participants in this study may receive a placebo. 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?
Perception of effort during running. (time frame: 1 day). 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 30 Dec 2025.