- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03712592
Physiological Constraints Associated With Trail Running (UT4M2018)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Grenoble, France, 38043
- CHU Grenoble-Alpes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Man or woman
- 18-55 years
- Absence of chronic cardiovascular, respiratory, metabolic or neuromuscular disease
- > 3 years of trail running (at least 1 race> 40 km / year completed and a race> 100 km completed (trail group 160 km)
- Medical certificate of no contraindication to the practice of the trail
- Subjects available in Grenoble before and within 15 days after the race
- Subjects affiliated to a social security scheme
- Subjects able to sign informed consent.
Exclusion Criteria:
- Cardiorespiratory, metabolic and neurological diseases
- Non-Echogenic Subjects
- Subjects with chronic sleep disorders
- Psychiatric pathologies or ATCD of behavioral disorders
- Persons refusing to sign the information sheet and the participation agreement,
- persons under guardianship or not subject to a social security scheme,
- Pregnant woman, parturient, breastfeeding mother
- Person deprived of liberty by judicial or administrative decision,
- Person subject to a legal protection measure, who can not be included in clinical trials.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 160km
|
Each visit will include a series of neuromuscular, cardiovascular, blood glucose and body composition evaluations will be performed. The subjects will provide some information about their muscular pain and their food and water intake. Finally, for the study of sleep that only concerns participants in the 4x40 km race, a home sleep registration banner will be given to each participant of the event step by step at the arrival of each stage in order to study sleep the next night as well as 2 nights after the arrival of the last stage. |
EXPERIMENTAL: 40km
|
Each visit will include a series of neuromuscular, cardiovascular, blood glucose and body composition evaluations will be performed. The subjects will provide some information about their muscular pain and their food and water intake. Finally, for the study of sleep that only concerns participants in the 4x40 km race, a home sleep registration banner will be given to each participant of the event step by step at the arrival of each stage in order to study sleep the next night as well as 2 nights after the arrival of the last stage. |
EXPERIMENTAL: 100km
|
Each visit will include a series of neuromuscular, cardiovascular, blood glucose and body composition evaluations will be performed. The subjects will provide some information about their muscular pain and their food and water intake. Finally, for the study of sleep that only concerns participants in the 4x40 km race, a home sleep registration banner will be given to each participant of the event step by step at the arrival of each stage in order to study sleep the next night as well as 2 nights after the arrival of the last stage. |
EXPERIMENTAL: 4x40km
|
Each visit will include a series of neuromuscular, cardiovascular, blood glucose and body composition evaluations will be performed. The subjects will provide some information about their muscular pain and their food and water intake. Finally, for the study of sleep that only concerns participants in the 4x40 km race, a home sleep registration banner will be given to each participant of the event step by step at the arrival of each stage in order to study sleep the next night as well as 2 nights after the arrival of the last stage. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantification of the level of ankle extensors fatigue induced by trail
Time Frame: one month and 12 days
|
Pre-post-force decrease in muscle contractility of ankle extensors assessed by neurostimulation
|
one month and 12 days
|
Quantification of the level of knee extensors fatigue induced by trail
Time Frame: one month and 12 days
|
Pre-post-force decrease in muscle contractility of knee extensors assessed by neurostimulation
|
one month and 12 days
|
Quantification of the level of ankle extensors fatigue induced by trail
Time Frame: one month and 12 days
|
Pre-post-force decrease in muscle contractility of infarction assessed by echocardiography
|
one month and 12 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC18.096
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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