Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Water-Inertia-Based Dynamic Stability Training for Balance and Postural Control in Healthy Young Women

10. september 2026 opdateret af: Yuanyan Huang

Effects of Water-Inertia-Based Dynamic Stability Training on Dynamic Balance and Single-Leg Postural Control in Healthy Young Women: A Randomized Controlled Trial

This randomized controlled study evaluated the effects of a 10-week dynamic stability training program using a mobile water load compared with a mass-matched stable load in healthy young women. Thirty participants were randomly assigned to either water-inertia-based unstable-load training or stable-load training. Both groups completed the same supervised exercises three times per week, using vests with the same total external mass; the main difference between groups was whether the load inside the vest was mobile or stable. Outcomes were assessed before training, after 5 weeks, and after 10 weeks. The study evaluated dynamic balance, postural sway during single-leg stance, and other physical-performance outcomes to determine whether mobile water loading produced different training adaptations from stable loading.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Afsluttet

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

This study was designed to examine whether dynamic stability training performed with a mobile water-based external load produces different physical and postural adaptations from the same training performed with a mass-matched stable external load in healthy young women. The study used a randomized, parallel-group design.

Healthy female university students aged 19-25 years who had not participated in resistance training during the previous 12 months were recruited. After baseline assessment, 30 eligible participants were randomly assigned in a 1:1 ratio to an unstable-load training group or a stable-load training group.

Both groups completed the same supervised dynamic stability training program three times per week for 10 weeks, for a total of 30 training sessions. Each session lasted approximately 50 minutes. The exercise content, training frequency, session duration, set-repetition structure, rest intervals, vest mass, and any additional prescribed exercise loads were matched between groups. During the main training block, participants completed three sets of each exercise, with 12 repetitions per set during weeks 1-5 and 15 repetitions per set during weeks 6-10.

The unstable-load group trained while wearing an Aqua Vest containing a total external load of 5 kg, consisting of approximately 4 kg of water and a 1-kg vest. Because the water pouches were partially filled, the internal water could move during exercise and change the distribution of the external load. The stable-load group wore a mass-matched weighted vest containing approximately 4 kg of steel rods and a 1-kg vest. The steel rods were arranged to approximate the spatial distribution of the water pouches. Thus, the primary experimental difference between groups was the mobility of the external load rather than total vest mass or prescribed exercise content.

Assessments were conducted at baseline, after 5 weeks of training, and after 10 weeks of training. Dynamic postural control was evaluated using the Y-Balance Test. Participants completed reaching tasks in the anterior, posteromedial, and posterolateral directions while standing on one limb. The maximum valid reach distance in each direction was retained and normalized to limb length, and a composite score was also calculated.

Postural sway was evaluated during single-leg stance using force-platform-derived center-of-pressure measures under eyes-open and eyes-closed conditions. Eyes-open trials lasted 30 seconds and eyes-closed trials lasted 20 seconds. Center-of-pressure outcomes included total path distance and direction-specific root-mean-square displacement in the anteroposterior and mediolateral directions.

The broader study protocol also included lower-extremity physical-performance assessments. The registration record is intended to describe the original study protocol and design; individual publications arising from the study may focus on specific subsets of the collected outcomes.

The purpose of the comparison was to determine whether introducing load mobility through a water-filled vest, while keeping the prescribed exercise program and external mass closely matched, resulted in different adaptations from training with a stable weighted vest.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
30

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydkorea
      • Busan, Sydkorea
        • Busan University of Foreign Studies

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Female undergraduate students aged 19 to 25 years.
  • Generally healthy at the time of enrollment.
  • No surgery within the previous 6 months.
  • No congenital, neurological, vestibular, or musculoskeletal disorder affecting the foot, pelvis, or spine.
  • No participation in resistance training during the previous 12 months. Able and willing to participate in the 10-week supervised exercise intervention and study assessments.
  • Provided written informed consent to participate.

Exclusion Criteria:

  • Did not meet any of the inclusion criteria.
  • Participated in resistance training or functional training outside the study intervention during the 10-week study period.
  • Developed a health condition, injury, or other circumstance during the study that prevented safe participation in the prescribed exercise program or outcome assessments.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Water-Inertia-Based Unstable-Load Training
Participants assigned to this arm completed a supervised 10-week dynamic stability training program three times per week while wearing an Aqua Vest with a total external load of 5 kg, consisting of approximately 4 kg of water and a 1-kg vest. The partially filled water pouches allowed internal water movement during exercise, creating a mobile external load. Exercise content, session duration, set-repetition structure, rest intervals, and any additional prescribed exercise loads were matched to the stable-load training arm.
Adfærdsmæssigt: Water-Inertia-Based Dynamic Stability Training
Participants completed a supervised dynamic stability training program three times per week for 10 weeks (30 sessions), with each session lasting approximately 50 minutes. During training, participants wore a vest providing a total external load of 5 kg, consisting of approximately 4 kg of water in partially filled pouches and a 1-kg vest. Internal water movement allowed the external load distribution to change during exercise. Exercises were performed for three sets, with 12 repetitions per set during weeks 1-5 and 15 repetitions per set during weeks 6-10, with 30 seconds of rest between sets. Exercise content and any additional prescribed implement loads were matched to the stable-load intervention.
Andre navne:
  • Unstable-Load Training (ULT)
  • Aqua Vest Training
Aktiv komparator: Stable-Load Training
Participants assigned to this arm completed the same supervised 10-week dynamic stability training program three times per week while wearing a mass-matched stable weighted vest with a total external load of 5 kg, consisting of approximately 4 kg of steel rods and a 1-kg vest. The steel rods were arranged to approximate the spatial loading configuration of the water pouches. Exercise content, session duration, set-repetition structure, rest intervals, and any additional prescribed exercise loads were matched to the unstable-load training arm.
Adfærdsmæssigt: Stable-Load Dynamic Stability Training
Participants completed the same supervised dynamic stability training program three times per week for 10 weeks (30 sessions), with each session lasting approximately 50 minutes. During training, participants wore a stable weighted vest providing a total external load of 5 kg, consisting of approximately 4 kg of steel rods and a 1-kg vest. The steel rods were arranged to approximate the spatial loading configuration of the water pouches used in the water-inertia intervention. Exercises were performed for three sets, with 12 repetitions per set during weeks 1-5 and 15 repetitions per set during weeks 6-10, with 30 seconds of rest between sets. Exercise content and any additional prescribed implement loads were matched between groups.
Andre navne:
  • Stable-Load Training (SLT)
  • Weighted Vest Training

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Normalized Anterior Reach Distance on the Y-Balance Test
Tidsramme: Baseline, Week 5, and Week 10
Dynamic postural control was assessed using the lower-quarter Y-Balance Test. Participants performed three valid anterior reach trials while maintaining single-leg stance. The maximum reach distance was retained and normalized to the corresponding limb length: normalized reach distance (%) = maximum reach distance / limb length × 100. Higher values indicate greater normalized reach performance.
Baseline, Week 5, and Week 10
Normalized Posteromedial Reach Distance on the Y-Balance Test
Tidsramme: Baseline, Week 5, and Week 10
Participants performed three valid posteromedial reach trials during the lower-quarter Y-Balance Test. The maximum reach distance was retained and normalized to the corresponding limb length: normalized reach distance (%) = maximum reach distance / limb length × 100. Higher values indicate greater normalized reach performance.
Baseline, Week 5, and Week 10
Normalized Posterolateral Reach Distance on the Y-Balance Test
Tidsramme: Baseline, Week 5, and Week 10
Participants performed three valid posterolateral reach trials during the lower-quarter Y-Balance Test. The maximum reach distance was retained and normalized to the corresponding limb length: normalized reach distance (%) = maximum reach distance / limb length × 100. Higher values indicate greater normalized reach performance.
Baseline, Week 5, and Week 10
Y-Balance Test Composite Score
Tidsramme: Baseline, Week 5, and Week 10
The composite score was calculated from the maximum valid anterior, posteromedial, and posterolateral reach distances normalized to limb length: composite score (%) = (maximum anterior + maximum posteromedial + maximum posterolateral reach distance) / (3 × limb length) × 100. Higher values indicate greater overall Y-Balance Test performance.
Baseline, Week 5, and Week 10
Center-of-Pressure Total Distance During Eyes-Open Single-Leg Stance
Tidsramme: Baseline, Week 5, and Week 10
Postural sway was assessed using a force platform during 30-second eyes-open single-leg stance. Total CoP distance (cm) represented the cumulative path length of the center-of-pressure trajectory during each valid trial. Three trial-specific values were averaged for analysis. Lower values represent a shorter CoP trajectory during the test condition.
Baseline, Week 5, and Week 10
Anteroposterior CoP RMS During Eyes-Open Single-Leg Stance
Tidsramme: Baseline, Week 5, and Week 10
Anteroposterior root-mean-square (AP RMS) displacement of the center of pressure was calculated during 30-second eyes-open single-leg stance and expressed in centimeters. AP RMS represents the dispersion of CoP displacement about its mean position in the anteroposterior direction. Three trial-specific values were averaged for analysis.
Baseline, Week 5, and Week 10
Mediolateral CoP RMS During Eyes-Open Single-Leg Stance
Tidsramme: Baseline, Week 5, and Week 10
Mediolateral root-mean-square (ML RMS) displacement of the center of pressure was calculated during 30-second eyes-open single-leg stance and expressed in centimeters. ML RMS represents the dispersion of CoP displacement about its mean position in the mediolateral direction. Three trial-specific values were averaged for analysis.
Baseline, Week 5, and Week 10
Center-of-Pressure Total Distance During Eyes-Closed Single-Leg Stance
Tidsramme: Baseline, Week 5, and Week 10
Postural sway was assessed using a force platform during 20-second eyes-closed single-leg stance. Total CoP distance (cm) represented the cumulative path length of the center-of-pressure trajectory during each valid trial. Three trial-specific values were averaged for analysis. Lower values represent a shorter CoP trajectory during the test condition.
Baseline, Week 5, and Week 10
Anteroposterior CoP RMS During Eyes-Closed Single-Leg Stance
Tidsramme: Baseline, Week 5, and Week 10
Anteroposterior root-mean-square (AP RMS) displacement of the center of pressure was calculated during 20-second eyes-closed single-leg stance and expressed in centimeters. AP RMS represents the dispersion of CoP displacement about its mean position in the anteroposterior direction. Three trial-specific values were averaged for analysis.
Baseline, Week 5, and Week 10
Mediolateral CoP RMS During Eyes-Closed Single-Leg Stance
Tidsramme: Baseline, Week 5, and Week 10
Mediolateral root-mean-square (ML RMS) displacement of the center of pressure was calculated during 20-second eyes-closed single-leg stance and expressed in centimeters. ML RMS represents the dispersion of CoP displacement about its mean position in the mediolateral direction. Three trial-specific values were averaged for analysis.
Baseline, Week 5, and Week 10
Knee Extension Peak Torque Relative to Body Weight at 60°/s
Tidsramme: Baseline, Week 5, and Week 10
Concentric knee extension strength was assessed using an isokinetic dynamometer at an angular velocity of 60°/s. Peak torque was normalized to body weight and expressed as a percentage of body weight (PT/BW, %). Higher values indicate greater knee extensor torque relative to body weight.
Baseline, Week 5, and Week 10
Knee Flexion Peak Torque Relative to Body Weight at 60°/s
Tidsramme: Baseline, Week 5, and Week 10
Concentric knee flexion strength was assessed using an isokinetic dynamometer at an angular velocity of 60°/s. Peak torque was normalized to body weight and expressed as a percentage of body weight (PT/BW, %). Higher values indicate greater knee flexor torque relative to body weight.
Baseline, Week 5, and Week 10
Ankle Inversion Peak Torque Relative to Body Weight at 60°/s
Tidsramme: Baseline, Week 5, and Week 10
Concentric ankle inversion strength was assessed using an isokinetic dynamometer at an angular velocity of 60°/s. Peak torque was normalized to body weight and expressed as a percentage of body weight (PT/BW, %). Higher values indicate greater inversion torque relative to body weight.
Baseline, Week 5, and Week 10
Ankle Eversion Peak Torque Relative to Body Weight at 60°/s
Tidsramme: Baseline, Week 5, and Week 10
Concentric ankle eversion strength was assessed using an isokinetic dynamometer at an angular velocity of 60°/s. Peak torque was normalized to body weight and expressed as a percentage of body weight (PT/BW, %). Higher values indicate greater eversion torque relative to body weight.
Baseline, Week 5, and Week 10
Ankle Inversion Peak Torque Relative to Body Weight at 120°/s
Tidsramme: Baseline, Week 5, and Week 10
Concentric ankle inversion strength was assessed using an isokinetic dynamometer at an angular velocity of 120°/s. Peak torque was normalized to body weight and expressed as a percentage of body weight (PT/BW, %). Higher values indicate greater inversion torque relative to body weight.
Baseline, Week 5, and Week 10
Ankle Eversion Peak Torque Relative to Body Weight at 120°/s
Tidsramme: Baseline, Week 5, and Week 10
Concentric ankle eversion strength was assessed using an isokinetic dynamometer at an angular velocity of 120°/s. Peak torque was normalized to body weight and expressed as a percentage of body weight (PT/BW, %). Higher values indicate greater eversion torque relative to body weight.
Baseline, Week 5, and Week 10

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Knee Extension Test Range of Motion at 60°/s
Tidsramme: Baseline, Week 5, and Week 10
Range of motion recorded by the isokinetic dynamometer during the knee extension test performed at 60°/s, expressed in degrees. This measure represents the angular range recorded during the corresponding isokinetic testing condition.
Baseline, Week 5, and Week 10
Knee Flexion Test Range of Motion at 60°/s
Tidsramme: Baseline, Week 5, and Week 10
Range of motion recorded by the isokinetic dynamometer during the knee flexion test performed at 60°/s, expressed in degrees.
Baseline, Week 5, and Week 10
Ankle Inversion Test Range of Motion at 60°/s
Tidsramme: Baseline, Week 5, and Week 10
Range of motion recorded by the isokinetic dynamometer during the inversion test performed at 60°/s, expressed in degrees. This measure represents the angular range recorded during the corresponding isokinetic testing condition.
Baseline, Week 5, and Week 10
Ankle Eversion Test Range of Motion at 60°/s
Tidsramme: Baseline, Week 5, and Week 10
Range of motion recorded by the isokinetic dynamometer during the eversion test performed at 60°/s, expressed in degrees. This measure represents the angular range recorded during the corresponding isokinetic testing condition.
Baseline, Week 5, and Week 10
Ankle Inversion Test Range of Motion at 120°/s
Tidsramme: Baseline, Week 5, and Week 10
Range of motion recorded by the isokinetic dynamometer during the inversion test performed at 120°/s, expressed in degrees. This measure represents the angular range recorded during the corresponding isokinetic testing condition.
Baseline, Week 5, and Week 10
Ankle Eversion Test Range of Motion at 120°/s
Tidsramme: Baseline, Week 5, and Week 10
Range of motion recorded by the isokinetic dynamometer during the eversion test performed at 120°/s, expressed in degrees. This measure represents the angular range recorded during the corresponding isokinetic testing condition.
Baseline, Week 5, and Week 10

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Yuanyan Huang

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
5. juli 2024

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
20. september 2024

Studieafslutning (Faktiske)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
20. september 2024

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
4. september 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
4. september 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
10. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
14. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
10. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 2024-0666-001
  • P01-202407-01-004 (Anden identifikator: Public Institutional Bioethics Committee, Republic of Korea)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data that support the findings of the study may be shared with qualified researchers upon reasonable request, subject to applicable ethical and data-protection requirements.

IPD-delingstidsramme

Beginning after publication of the primary study results, with no predetermined end date.

IPD-delingsadgangskriterier

De-identified individual participant data may be shared with qualified researchers upon reasonable request for scientifically appropriate purposes. Requests should include a brief research proposal and planned analyses and will be reviewed for ethical, privacy, and data-protection considerations. Approved data will be provided by the study investigator.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Cookieindstillinger

Vi bruger cookies for at sikre, at vi giver dig den bedste oplevelse på vores hjemmeside. For flere detaljer skal du læse omhyggeligt vores Politik om beskyttelse af personlige oplysninger og cookies. ...>>>Du kan når som helst ændre dine præferencer eller trække dit samtykke tilbage ved at slette cookies fra din hjemmeside eller computer som beskrevet i politikken. Accepter det og vælg dine præferencer ved at markere de tilsvarende felter i afsnittet "Administrer indstillinger" nedenfor. Læs vores servicevilkår omhyggeligt, inden du fortsætter med at bruge nogen del af dette websted.
«Administrer indstillinger