Fatigue and Recovery: a Comparison Between Trail and Marathon (MARA-TRAIL)

March 9, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne
Road marathon is a famous running race known for hundreds of years. Trail running is an emerging running discipline which count new runners every year. Trail running and road marathon are two running endurance disciplines which differed by variation of elevation and nature of the terrain. While marathon is essentially run on flat roads, trail races are realized on steep paths (mountain, desert…) with an important variation of elevation. Neuromuscular, biomechanical and physiological consequences are different depending on the discipline, especially with a greater eccentric contribution in trail running. In spite of this characteristic, trail runners take part in several races longer than 40 km per year, while road runners participate in one to two marathons per year.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Some studies focused on fatigue and recovery following 30-to-40-km trail races or marathon but no direct comparison between both disciplines have been done yet. A direct comparison between marathon and trail would aim to better understand if the occurrence of fatigue is more important or if the recovery is longer in one of the two disciplines. The comparison is also a way to better understand mechanisms involved in fatigue and recovery following a trail and a marathon. Then, this research could be applied to improve specificity of training and prevent risk of injuries. This project aims to compare fatigue and recovery following a trail and a marathon.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • France
      • Saint-Etienne, France, France, 42055
        • Unités de Myologie et de Médecine du Sport

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Common for MARASIM, TRAILSIM and TRAILNAT:

  • Male or female
  • 18-55 years old
  • Endurance runners who run at least one running session of 20 km per week
  • Being able to run a marathon under 5 h or finishing a trail of 30 km during the last 3 years
  • Refrain from participating to a competition one month before the first visit and during the duration of the study
  • To have a medical certificate of no contraindication of running practise in competition
  • Registered with a social security scheme
  • Having given the written consent freely

Specific for the 3 groups :

  • Specialist of trail running (TRAILSIM and TRAILNAT)
  • Specialist of road running (MARASIM)

Exclusion Criteria:

  • Subjects who present cardiac or articular chronic pathologies (example: repeated sprain, patellar or joint problems)
  • Subjects who present chronic or central neurological pathologies
  • Subjects deprived of liberty or who should be legally deprived
  • Subjects who report to take forbidden products by the World Anti-Doping Agency
  • pregnant or breastfeeding woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: MARASIM
During visit 2, road runners will take part in a simulated marathon race on a treadmill.
Other: Race: Simulated marathon
Participants will take part in a race: simulated marathon. Before, during, immediately after and the month after the race, neuromuscular, physiological and biomechanical assessments will take place.
Active Comparator: TRAILSIM
During visit 2, trail runners will take part in a simulated trail race on a treadmill.
Other: Race: Simulated trail
Participants will take part in a race: simulated trail. Before, during, immediately after and the month after the race, neuromuscular, physiological and biomechanical assessments will take place.
Active Comparator: TRAILNAT
During visit 2, trail runners will take part in a real trail race in the nature.
Other: Race: Trail in nature
Participants will take part in a race: trail in nature. Before, during, immediately after and the month after the race, neuromuscular, physiological and biomechanical assessments will take place.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in knee extensors maximal isometric torque output
Time Frame: Day 0 (day of the race) baseline value = 30 minutes before the race and 15 minutes after the race
The primary outcome will be changed (in % of baseline value) of the maximal voluntary torque (in Nm) produced by the knee extensors, measured at D0 (= day of the race) with an isometric knee dynamometer (ARS dynamometry, SP2, Ltd., Ljubljana, Slovenia), before (baseline value = 30 minutes before the race) and at the end (15 minutes after the race) of a marathon or a trail (depending on the group)
Day 0 (day of the race) baseline value = 30 minutes before the race and 15 minutes after the race

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resting heart rate variability parameters
Time Frame: 3 times in the 2 weeks before the race and every other day for the month following the race

Evolution of resting heart rate variability, a marker of psychophysiological recovery will be assessed through a Polar H10 heart rate monitor before the race (at least 3 times in the 2 weeks before the race) and during recovery (at least every two days until one month after the race).

Analysis of time domain and frequency domain variables via measurement of heart rate variability will be achieved through HRV analysis software.
3 times in the 2 weeks before the race and every other day for the month following the race
Change in plantar flexor maximal isometric torque output
Time Frame: Day 0 (day of the race) baseline value = 30 minutes before the race and 15 minutes after the race, Days 1, 2, 7
Change (in % of baseline value) of the maximal voluntary torque (in Nm) produced by the plantar flexor measured at D0, by an instrumental pedal placed at 45 degrees with respect to the horizontal (ATI Industrial Automation, Inc., Apex, North Carolina USA), before (baseline value) and at the end of a marathon or a trail (depending on the group), and during recovery at Day1 Day2 Day7).
Day 0 (day of the race) baseline value = 30 minutes before the race and 15 minutes after the race, Days 1, 2, 7
Recovery of quadriceps maximal isometric torque output the month after the race
Time Frame: Day 0 (day of the race) baseline value = 30 minutes before the race, (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Change (in % of post-exercise baseline value) of the maximal voluntary torque (in Nm) produced by the knee extensors, measured with an isometric knee dynamometer (ARS dynamometry, SP2, Ltd., Ljubljana, Slovenia), during recovery at Day 1 Day 2 Day 7).
Day 0 (day of the race) baseline value = 30 minutes before the race, (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Voluntary activation level
Time Frame: D0 (day of the race) baseline value = 30 min before the race, in the middle of the race (except for the trail in the nature) and 15 min after the race;D1 = 24h after the end of the race , D2 = 48h after the end of the race, D7 = 7 days after the end

Voluntary activation level (in %) of the plantar flexors and knee extensors will be assessed through neuromuscular assessments before, in the middle (except for the trail in the nature), after the marathon or trail of equivalent effort, and during recovery (Day 1, Day 2, and Day 7).

Voluntary activation level will be calculated as followed:

VA (%) = (1- (superimposed Db100/ resting Db100))x100
D0 (day of the race) baseline value = 30 min before the race, in the middle of the race (except for the trail in the nature) and 15 min after the race;D1 = 24h after the end of the race , D2 = 48h after the end of the race, D7 = 7 days after the end
Force assessed in dynamic
Time Frame: Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Force assessed in dynamic mode on a cycloergometer (Monark, Vansbro, Sweden) composed of strain gauges, a flywheel, a belt and an optical encoder allowing data collection. Force (N) will be measured in order to establish a force-velocity / power- velocity profile at Day 0 15 min before the race, after the marathon or trail ( 1 hour after the end) of equivalent effort, and during recovery (Day 1 (= 24h after the end of the race) , Day 2 (= 48 h after the end of the race), Day 7 (= 7 days after the end of the race).
Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Velocity assessed in dynamic
Time Frame: Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Velocity assessed in dynamic mode on a cycloergometer (Monark, Vansbro, Sweden) composed of strain gauges, a flywheel, a belt and an optical encoder allowing data collection. Speed (rad/s) will be measured in order to establish a force-velocity / power-velocity profile before (=15 minutes before the race), after the marathon or trail (=1 hour after the end) of equivalent effort, and during recovery (Day 1 = 24hours after the end of the race, Day 2 = 48hours after the end of the race, Day 7 = 7 days after the end of the race).
Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Power assessed in dynamic
Time Frame: Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Power assessed in dynamic mode on a cycloergometer (Monark, Vansbro, Sweden) composed of strain gauges, a flywheel, a belt and an optical encoder allowing data collection. Power (W) will be measured in order to establish a force-velocity / power-velocity profile before (=15 minutes before the race), after the marathon or trail (=1 hour after the end) of equivalent effort, and during recovery (Day 1 = 24hours after the enf of the race, Day 2 = 45hours after the end of the race, Day 7= 7 days after the race).
Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Muscular power and stretch-shortening cycle assessed through squat jumps
Time Frame: Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Muscular power and stretch-shortening cycle assessed through squat jump ; Height (m) and duration (s) of jumps are calculated through force platform (90 x90 cm, Model 9287C, Kisler, Winterthur, Switzerland).
Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Muscular power and stretch-shortening cycle assessed through countermovement jump
Time Frame: Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Muscular power and stretch-shortening cycle assessed through countermovement. Height (meter) and duration (seconde) of jumps are calculated through force platform (90 x90 centimeter, Model 9287C, Kisler, Winterthur, Switzerland)
Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day1 (= 24 hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Muscular power and stretch-shortening cycle assessed through drop jump
Time Frame: Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Muscular power and stretch-shortening cycle assessed through drop jump. Height (m) and duration (s) of jumps are calculated through force platform (90 x90 cm, Model 9287C, Kisler, Winterthur, Switzerland)
Day 0 15 minutes before the race, after the marathon or trail ( 1 hour after the end), and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Muscle electrical activity
Time Frame: Day 0: 30 minutes before the race, in the middle (except for the trail in the nature) 15 minutes after the end of the race
Muscle electrical activity (Trigno avanti Sensor, Delsys, Natick, MA including electrodes connected to thin-10-cm-long cables) are measured
Day 0: 30 minutes before the race, in the middle (except for the trail in the nature) 15 minutes after the end of the race
The kinetics of energy cost
Time Frame: Day 0 1 hour 30 minutes before the race,in the middle, 30 minutes after the end of the race, and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
The kinetics of energy cost (Ccr en J/kg/m) measured using a portable gas exchange measurement system (Ergospirometer Metamax 3B®, Cortex Medical, Leipzig, Germany) 1h30 before the race, in the middle (except for the trail in the nature) and 30 min after the race the marathon or simulated trail and during recovery Day 1, Day 2, Day 7 7)7).measurement system (Ergospirometer Metamax 3B®, Cortex Medical, Leipzig, Germany)
Day 0 1 hour 30 minutes before the race,in the middle, 30 minutes after the end of the race, and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Racing kinematics
Time Frame: 1 hour before, in the middle and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).

Evolution of moments and hip joint angles, knee and ankle measured by a Markerless tracking system will be measured

1 hour before the race , in the middle (except for the trail in the nature), immediately after the simulated trail or marathon, and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48hours after the end of the race), Day 7 (= 7 days after the end of the race).
1 hour before, in the middle and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Ground reaction force (in Newton)
Time Frame: 1hour before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48hours after the end of the race), Day 7 (= 7 days after the end of the race).
Force will be measured by force platforms contained in the treadmill (h/p/Cosmos-Stellar, Germany). to get the ground reaction forces at each step 1hour before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48hours after the end of the race), Day 7 (= 7 days after the end of the race).
1hour before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48hours after the end of the race), Day 7 (= 7 days after the end of the race).
Center of pressure (in Newton)
Time Frame: 1hour before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Force will be measured by force platforms contained in the treadmill (h/p/Cosmos-Stellar, Germany). to get the center of pressure each step before (=1 hour before), in the middle (except for the trail in the nature), after (=immediately after the race) the simulated trail or marathon, and during recovery (Day 1 = 24 hours after the race, Day 2 = 48 hours after the race, Day 7 = 7 days after the race)
1hour before, in the middle (except for the trail in the nature) and immediately after the race and during recovery(Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Muscle damage blood markers
Time Frame: Day 0: 2hours before the race, 2hours after the race and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Witness muscle damage following a marathon or a trail of equivalent effort. Biological variables are taken 2h before the race and 2 h after the race: a marathon or a trail of equivalent effort, and during recovery ((Day 1 (= 24h after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race). Followed i- Inflammatory parameters are taken through blood test (2 tubes of 5 ml/blood test): ionogram (sodium [mmol/l], potassium [mmol/l], chlorine [mmol/l], bicarbonates [mmol/l], urea [mmol/l], creatinine [µmol/l], glucose [mmol/l], proteins [g/l], uric acid [[µmol/l ], osmolality [m0smol/kg]; Creatine Kinase (UI/l)myoglobine [µg/l ], C reactive Protein [mg/l], lactate [mmol/l]
Day 0: 2hours before the race, 2hours after the race and during recovery (Day 1 (= 24hours after the end of the race) , Day 2 (= 48 hours after the end of the race), Day 7 (= 7 days after the end of the race).
Effort perception
Time Frame: D0 (day of the race) : during the race, every 5 kilometers effort
Perception of effort will be assessed during the marathon or trail of equivalent effort every 5 km effort on the modified Borg scale (from 0 - rest to 10 - Maximal perceived effort).
D0 (day of the race) : during the race, every 5 kilometers effort
Fatigue assessment
Time Frame: Once during 2 weeks before, immediately after the race and during recovery (Day 1 = 24 hours after the race, Day 2 = 48 hours after, Day 3 = 72 hours after, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21 and Day 30 after the race
Fatigue assessment will be carried out before (=once during the 2 weeks before the race) the marathon or trail of equivalent effort , immediately after and during recovery (Day 1 = 24 hours after the race, Day 2 = 48 hours after the race, Day 3 = 72 hours after the race, Day 4 = 4 days after the race, Day 5 = 5 days after the race, Day 6 = 6 days after the race, Day 7 = 7 days after the race, Day 14 = 14 days after the race, Day 21 = 21 days after the race, Day 30 = 30 days after the race) via the of the "Rating scale of fatigue " (from 0 - Not fatigued at all to 10 - Total exhaustion nothing left).
Once during 2 weeks before, immediately after the race and during recovery (Day 1 = 24 hours after the race, Day 2 = 48 hours after, Day 3 = 72 hours after, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21 and Day 30 after the race
Muscular pain
Time Frame: Day 0 (day of the race) : during the race, every 5 kilometers effort
Muscle pain felt in the quadriceps and calves will be rated on a visual analog scale ranging from 0 (No muscular pain at all) at 10 (Unbearable muscle pain) during the marathon or trail of equivalent effort every 5 km-effort
Day 0 (day of the race) : during the race, every 5 kilometers effort

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leonard FEASSON, MD PhD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23CH132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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