A Multiphase Analysis of Next-generation Trail Footwear (NEXTGENTRAIL)

September 28, 2026 updated by: Fernando González-Mohíno Mayoralas

A Multiphase Analysis of Next-generation Trail Footwear: Optimising Advanced Footwear Technology From Laboratory Outcomes to Field-based Running Performance

This study will investigate how different advanced-foam trail-running footwear configurations affect running economy, performance, comfort, and fatigue in competitive trail runners. The project aims to determine whether footwear characteristics, particularly foam properties and stack height, influence physiological and biomechanical responses during both controlled laboratory running and real-world trail running.

Approximately 30 competitive trail runners with experience in technical trail running and no musculoskeletal injury during the previous six months will participate. The study will use a two-phase experimental design.

In Phase 1, participants will complete running economy assessments in three footwear conditions in randomized order. The footwear conditions will include a high-stack advanced-foam prototype, a medium-stack advanced-foam prototype, and a conventional-foam shoe. Laboratory testing will be performed during uphill and downhill treadmill running. Participants will also complete field-based running economy trials on real trail terrain at a controlled speed, followed by a short time trial to establish a representative running pace.

In Phase 2, participants will complete prolonged trail-running sessions in the two advanced-foam footwear configurations on a 15-km trail course. Running economy and fatigue-related responses will be assessed repeatedly during the prolonged exercise sessions to evaluate changes in physiological and biomechanical efficiency over time.

The primary physiological outcome will be running economy, assessed through oxygen consumption and energy cost. Additional outcomes will include heart rate, step frequency, step length, ground contact time, perceived exertion, comfort, perceived performance, and pacing-related measures.

The study will compare laboratory and field responses to determine whether differences in running economy observed under controlled conditions are maintained during real trail running and whether footwear configuration influences the deterioration of running economy and fatigue during prolonged exercise.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Trail running involves substantial variations in terrain, gradient, and surface characteristics, creating physiological and biomechanical demands that differ from road running. Footwear may influence these responses through characteristics such as midsole foam properties, cushioning, and stack height. However, evidence regarding advanced footwear technology in trail running remains limited, particularly regarding whether laboratory findings translate to real-world trail conditions and whether footwear characteristics influence the maintenance of running performance during prolonged exercise.

The objective of this study is to investigate the effects of different advanced-foam trail-running footwear configurations on running economy, performance, comfort, biomechanical responses, and fatigue under laboratory and field-based trail-running conditions. The study will also examine whether footwear configuration influences durability, defined in this project as the maintenance of running economy and physiological efficiency during prolonged exercise.

The study will recruit approximately 30 competitive trail runners with experience in technical trail running who have been free from musculoskeletal injury for at least six months. Written informed consent will be obtained from all participants.

The study will use a two-phase experimental design.

In Phase 1, participants will be evaluated under three footwear conditions in randomized order:

  1. High-stack advanced-foam shoe prototype: approximately 38.5 mm stack height, 6-mm drop, and 220 g.
  2. Medium-stack advanced-foam shoe prototype: approximately 28.5 mm stack height, 6-mm drop, and 180 g.
  3. Conventional-foam footwear: approximately 31.5 mm stack height, 6-mm drop, and 300 g.

If necessary, shoe mass will be standardized by adding weight to the lighter footwear configurations to help isolate the effects of foam characteristics.

Laboratory running economy will be assessed using 5-minute running trials under uphill and downhill conditions. Uphill running will be performed at 8 km/h with a 6% positive slope, and downhill running at 16 km/h with a 6% negative slope. Oxygen uptake and carbon dioxide output will be measured breath-by-breath using a metabolic gas analysis system. Biomechanical variables will also be recorded, including step frequency and ground contact time.

Following the laboratory assessment, participants will complete field-based running economy trials on a real trail surface. Each footwear condition will be tested in randomized order during 5-minute running trials at a controlled speed of 12 km/h. Speed will be controlled using acoustic signals. Oxygen consumption and carbon dioxide production will be measured using a portable metabolic system, while spatiotemporal gait variables will be recorded using an inertial measurement device. Participants will subsequently complete a short time trial to establish a representative running pace for the subsequent durability assessment.

In Phase 2, participants will complete prolonged trail-running sessions using the two advanced-foam footwear configurations. Each footwear condition will be assessed during a separate visit. The sessions will consist of repeated running on a 15-km trail course comprising five 3-km loops and approximately 375 m of elevation gain. Running intensity will be based on the pace obtained during the Phase 1 time trial, according to the final study protocol.

Running economy will be assessed repeatedly during the prolonged exercise sessions using portable metabolic measurements. Changes in physiological efficiency and fatigue will be evaluated across the running session. GPS-based measurements will also be collected to monitor pacing and changes in running performance.

The main physiological outcome is running economy, assessed through oxygen consumption and energy cost relative to running speed. Additional physiological, biomechanical, and perceptual outcomes include heart rate, step frequency, step length, ground contact time, rating of perceived exertion, perceived comfort, perceived performance, and pacing-related measures.

The study is designed to determine whether footwear-related differences in running economy identified under controlled laboratory conditions are maintained during real-world trail running. It will also investigate whether advanced-foam footwear configurations influence the deterioration of running economy and fatigue during prolonged trail-running exercise. The findings are intended to contribute to the scientific understanding of interactions between trail-running footwear, biomechanics, physiological responses, and endurance performance.

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 (Estimated)

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.
30

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.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Competitive trail runners.
  • Experience in technical trail running.
  • Willingness to provide written informed consent.

Exclusion Criteria:

  • Musculoskeletal injury in the previous 6 months.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

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.
Experimental: High-Stack Advanced-Foam Footwear

Participants will perform the experimental running trials wearing a high-stack advanced-foam trail-running shoe (approximately 38.5 mm stack height, 6 mm drop, and 220 g). This footwear condition will be used to assess running economy, physiological and biomechanical responses, comfort, perceived performance, and fatigue-related changes during laboratory and field-based trail running.
Other: Running footwear

Three trail running shoes with different characteristics will be compared in terms of their physiological and biomechanical effects.
Experimental: Medium-Stack Advanced-Foam Footwear

Participants will perform the experimental running trials wearing a medium-stack advanced-foam trail-running shoe (approximately 28.5 mm stack height, 6 mm drop, and 180 g). This footwear condition will be used to assess running economy, physiological and biomechanical responses, comfort, perceived performance, and fatigue-related changes during laboratory and field-based trail running.
Other: Running footwear

Three trail running shoes with different characteristics will be compared in terms of their physiological and biomechanical effects.
Active Comparator: Conventional-Foam Footwear

Participants will perform the experimental running trials wearing a conventional-foam trail-running shoe (approximately 31.5 mm stack height, 6 mm drop, and 300 g). This footwear condition will serve as the conventional-footwear comparison for assessing running economy, physiological and biomechanical responses, comfort, perceived performance, and fatigue-related changes during laboratory and field-based trail running.
Other: Running footwear

Three trail running shoes with different characteristics will be compared in terms of their physiological and biomechanical effects.

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
Running economy
Time Frame: During each 5-minute running trial for each footwear model in Phase 1 (indoor laboratory conditions) and Phase 2 (outdoor trail-running conditions).

Running economy will be assessed through oxygen consumption (V̇O₂) and energy cost expressed in W·kg-¹ during running in the different footwear conditions. Measurements will be obtained using breath-by-breath gas analysis during controlled laboratory and field-based trail-running trials.
During each 5-minute running trial for each footwear model in Phase 1 (indoor laboratory conditions) and Phase 2 (outdoor trail-running conditions).

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
Heart Rate
Time Frame: During each 5-minute running trial for each footwear model in Phase 1 (indoor laboratory conditions) and Phase 2 (outdoor trail-running conditions).

Continuous heart rate will be recorded during the running trials to characterize the physiological response to each footwear condition.
During each 5-minute running trial for each footwear model in Phase 1 (indoor laboratory conditions) and Phase 2 (outdoor trail-running conditions).
Spatiotemporal Gait Parameters
Time Frame: During each 5-minute running trial for each footwear model in Phase 1 (indoor laboratory conditions) and Phase 2 (outdoor trail-running conditions).

Biomechanical responses will be assessed through step frequency (steps/min), step length (m), and ground contact time (ms) during running in the different footwear conditions.
During each 5-minute running trial for each footwear model in Phase 1 (indoor laboratory conditions) and Phase 2 (outdoor trail-running conditions).
Comfort, Perceived Performance, and Rate of Perceived Exertion
Time Frame: After each 5-minute running trial for each footwear model in Phase 1 (indoor laboratory conditions) and Phase 2 (outdoor trail-running conditions).

Participants' subjective perceptions of footwear comfort, perceived performance, and rate of perceived exertion will be assessed during the experimental running conditions.
After each 5-minute running trial for each footwear model in Phase 1 (indoor laboratory conditions) and Phase 2 (outdoor trail-running conditions).

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.
Fernando González-Mohíno Mayoralas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

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.
November 1, 2026

Primary Completion (Estimated)

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.
March 1, 2028

Study Completion (Estimated)

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.
March 1, 2028

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).
September 22, 2026

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.
September 28, 2026

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.
October 2, 2026

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.
October 2, 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.
September 28, 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.
September 1, 2026

More Information

Terms related to this study

Keywords

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.
  • CEIS-2026-174642
  • PID2025-170911NB-I00 (Other Grant/Funding Number: Agencia Estatal de Investigación. Ministerio de Ciencia, Innovación y Universidades)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators have not yet decided whether individual participant data (IPD) will be shared. A decision regarding IPD sharing will be made after completion of the study, taking into consideration ethical, legal, privacy, and data protection requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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