[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658669":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":35,"studyPopulation":24,"armGroups":36,"interventions":52,"overallOfficials":24,"centralContacts":57,"locations":24,"responsibleParty":63,"collaborators":24,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":76,"minAge":77,"maxAge":24,"enrollmentInfo":78,"targetDuration":24,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":94,"whyStopped":24,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":24},{"fullName":5,"class":6},"University of Castilla-La Mancha","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Running economy","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).",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Heart Rate","Continuous heart rate will be recorded during the running trials to characterize the physiological response to each footwear condition.",{"measure":18,"description":19,"timeFrame":12},"Spatiotemporal Gait Parameters","Biomechanical responses will be assessed through step frequency (steps\u002Fmin), step length (m), and ground contact time (ms) during running in the different footwear conditions.",{"measure":21,"description":22,"timeFrame":23},"Comfort, Perceived Performance, and Rate of Perceived Exertion","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).",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":24,"timePerspective":24,"maskingInfo":30},"RANDOMIZED","CROSSOVER","This study uses a two-phase, cross-sectional experimental design combining controlled laboratory assessments with ecological field-based trail-running testing.\n\nIn Phase 1, participants will complete experimental trials in three footwear conditions. The order of footwear conditions will be randomized.\n\nIn Phase 2, participants will complete repeated 15-km trail-running sessions using the two advanced-foam footwear configurations. Running economy will be assessed repeatedly during prolonged exercise to investigate changes in physiological cost and the potential durability-related deterioration of footwear performance.","TREATMENT",{"masking":31,"maskingDescription":32,"whoMasked":33},"SINGLE","Participants will be able to see the footwear used in each experimental condition; however, they will not be informed about the specific technical characteristics or differences between the footwear models, such as foam composition, stack height, or other performance-related features. The technical characteristics of the footwear will therefore be concealed from participants to minimize potential expectations or bias related to the footwear configuration.",[34],"PARTICIPANT","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.\n\nThe 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.\n\nThe 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.\n\nThe study will use a two-phase experimental design.\n\nIn Phase 1, participants will be evaluated under three footwear conditions in randomized order:\n\n1. High-stack advanced-foam shoe prototype: approximately 38.5 mm stack height, 6-mm drop, and 220 g.\n2. Medium-stack advanced-foam shoe prototype: approximately 28.5 mm stack height, 6-mm drop, and 180 g.\n3. Conventional-foam footwear: approximately 31.5 mm stack height, 6-mm drop, and 300 g.\n\nIf necessary, shoe mass will be standardized by adding weight to the lighter footwear configurations to help isolate the effects of foam characteristics.\n\nLaboratory running economy will be assessed using 5-minute running trials under uphill and downhill conditions. Uphill running will be performed at 8 km\u002Fh with a 6% positive slope, and downhill running at 16 km\u002Fh 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.\n\nFollowing 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\u002Fh. 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.\n\nIn 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.\n\nRunning 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.\n\nThe 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.\n\nThe 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.",[37,43,47],{"label":38,"type":39,"description":40,"interventionNames":41},"High-Stack Advanced-Foam Footwear","EXPERIMENTAL","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.",[42],"Other: Running footwear",{"label":44,"type":39,"description":45,"interventionNames":46},"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.",[42],{"label":48,"type":49,"description":50,"interventionNames":51},"Conventional-Foam Footwear","ACTIVE_COMPARATOR","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.",[42],[53],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":24},"Running footwear","Three trail running shoes with different characteristics will be compared in terms of their physiological and biomechanical effects.",[48,38,44],[58],{"name":59,"role":60,"phone":61,"phoneExt":24,"email":62},"Fernando González-Mohíno, PhD","CONTACT","+34 690216354","fernando.gmayoralas@uclm.es",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Fernando González-Mohíno Mayoralas","Senior Lecturer","100658669","a-multiphase-analysis-of-next-generation-trail-footwear-100658669",false,"NCT07855042","A Multiphase Analysis of Next-generation Trail Footwear","A Multiphase Analysis of Next-generation Trail Footwear: Optimising Advanced Footwear Technology From Laboratory Outcomes to Field-based Running Performance","NEXTGENTRAIL","Inclusion Criteria:\n\n* Competitive trail runners.\n* Experience in technical trail running.\n* Willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Musculoskeletal injury in the previous 6 months.",true,"ALL","18 Years",{"count":79,"type":80},30,"ESTIMATED","INTERVENTIONAL",[83],"NA","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.\n\nApproximately 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.\n\nIn 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.\n\nIn 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.\n\nThe 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.\n\nThe 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.",[86,87,88,89],"Running","Athletic Performance","Oxygen Consumption","Muscle Fatigue",[91,10,54,92,93],"Trail running","Uphill running","Downhill running","NOT_YET_RECRUITING","2026-09-28",{"date":97,"type":98},"2026-10-02","ACTUAL",{"date":100,"type":80},"2026-11",{"date":102,"type":80},"2028-03",{"name":65,"class":6}]