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Effects of Hourly Stair-Climbing Exercise Snacks on Metabolic and Vascular Health in Adults With Prediabetes (RISE UP)

23. september 2026 opdateret af: Hossein Rafiei, St. Louis University

RISE UP: Rapid Intense Stair Exercise for Unleashing Metabolic Potential in Prediabetes

This study will examine whether very short bouts of stair climbing performed throughout the day can improve blood sugar control and cardiovascular health in adults with prediabetes. Participants will complete three separate study visits in random order: uninterrupted sitting, sitting interrupted by 3-minute light walking breaks each hour, and sitting interrupted by brief stair-climbing exercise "snacks" each hour.

During each visit, the research team will measure glucose, insulin, blood lipids, markers of inflammation and oxidative stress, and blood-vessel function. Continuous glucose monitors, blood samples, heart-rate and blood-pressure measurements, vascular ultrasound, and questionnaires will be used to assess the participants' responses.

The goal of the study is to determine whether brief stair-climbing breaks may be a practical way to reduce the negative effects of prolonged sitting and improve metabolic health in adults with prediabetes.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

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 is a single-site, randomized, counterbalanced crossover pilot study evaluating the acute metabolic, vascular, and behavioral effects of interrupting prolonged sitting with brief stair-climbing exercise snacks in adults with prediabetes. A total of 20 participants will complete all three experimental conditions in randomized order, with a washout period of at least 7 days between visits.

The three experimental conditions are: (1) uninterrupted sitting, (2) sitting interrupted each hour by a 3-minute light walking break, and (3) sitting interrupted each hour by a brief stair-climbing exercise snack consisting of approximately 20 seconds of stair ascent at a fast but safe self-selected pace.

Participants will attend each experimental visit after an overnight fast. Two standardized meals will be provided during each approximately 6-hour experimental visit: Meal 1 at the beginning of the postprandial testing period and Meal 2 approximately 180 minutes later. Metabolic responses will be assessed using continuous glucose monitoring and serial blood sampling for glucose, insulin, lipids, inflammatory markers, and oxidative stress markers. Vascular responses will be assessed using noninvasive ultrasound. Heart rate, blood pressure, ratings of perceived exertion, symptoms, and participant-reported feasibility and acceptability will also be assessed.

The study is designed to determine whether brief hourly stair-climbing exercise snacks improve postprandial glucose and insulin responses and other cardiometabolic outcomes compared with uninterrupted sitting and light walking breaks, and to explore the feasibility and acceptability of this approach in adults with prediabetes.

Undersøgelsestype

Undersøgelsestype

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

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
20

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.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

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

18 år til 69 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Age 18 to 69 years, inclusive. Body mass index (BMI) 25.0 to 40.0 kg/m², inclusive.

Objectively confirmed prediabetes based on at least one of the following:

  • HbA1c 5.7% to 6.4%;
  • fasting plasma glucose 100 to 125 mg/dL; or
  • 2-hour plasma glucose 140 to 199 mg/dL during a 75-g oral glucose tolerance test.

Able to understand study procedures and provide written informed consent in English.

Able to safely perform repeated walking and vigorous stair-climbing activity based on medical history, resting vital signs, PAR-Q+ responses, investigator assessment, and medical clearance when required.

Able to safely undergo repeated venous blood collection and IV-catheter placement.

Able to safely consume the standardized study meals. Willing and able to complete all three experimental conditions and comply with fasting, dietary, physical-activity, medication, and pre-visit standardization instructions.

Exclusion Criteria:

BMI below 25.0 kg/m² or above 40.0 kg/m². Diagnosed type 1 or type 2 diabetes mellitus. Laboratory findings that do not confirm prediabetes or that suggest diabetes, including HbA1c ≥6.5%, fasting plasma glucose ≥126 mg/dL, or 2-hour plasma glucose ≥200 mg/dL during a 75-g oral glucose tolerance test.

Cardiovascular, pulmonary, musculoskeletal, neurological, or other medical conditions that would preclude safe participation in the walking or stair-climbing interventions.

Resting vital signs, current symptoms, or other screening findings indicating that exercise participation would be unsafe.

Pregnancy, plans to become pregnant during the study period, or breastfeeding. Current use of medications that may substantially affect glucose metabolism, lipid metabolism, body weight, study outcomes, or safe participation, including insulin, glucose-lowering medications, GLP-1 receptor agonists, pharmacologic weight-loss medications, systemic corticosteroids, or other medications judged by the investigator to interfere with study outcomes or safety.

Contraindications to vascular ultrasound, repeated blood collection, IV-catheter placement, or exercise participation.

Food allergies, intolerances, or dietary restrictions that prevent safe consumption of the standardized study meals.

Known allergy or severe skin sensitivity to adhesives used with continuous glucose monitors.

Bleeding disorder, current anticoagulant use, history of anemia, recent blood donation, recurrent fainting during blood collection, difficult venous access, or another condition judged to create unacceptable risk from repeated blood sampling or IV-catheter placement.

Inability to safely perform repeated walking or stair climbing. PAR-Q+ result requiring further medical evaluation when the participant does not obtain required written medical clearance.

Any other condition or finding that, in the judgment of the Principal Investigator or qualified study investigator, would make participation unsafe or substantially interfere with completion of study procedures.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

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.
Ingen indgriben: Uninterrupted Sitting

Participants will remain seated throughout the approximately 6-hour experimental visit, except as needed for study procedures. At the time points corresponding to activity bouts in the walking and stair-climbing conditions, participants will remain seated. This condition serves as the sedentary control condition.
Aktiv komparator: Hourly 3-Minute Light Walking Breaks

Participants will interrupt prolonged sitting with a 3-minute light walking break at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. Walking breaks will therefore occur at 60-minute intervals.
Adfærdsmæssigt: Hourly 3-Minute Light Walking Breaks

Participants will interrupt prolonged sitting with a 3-minute light walking break at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. Activity breaks are therefore separated by approximately 60 minutes. Participants will otherwise remain seated except as required for study procedures.
Eksperimentel: Hourly Stair-Climbing Exercise Snacks

Participants will interrupt prolonged sitting with brief stair-climbing exercise snacks at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. During each bout, participants will ascend approximately three flights of stairs at a fast but safe self-selected pace for about 20 seconds.
Adfærdsmæssigt: Hourly Stair-Climbing Exercise Snacks

Participants will interrupt prolonged sitting with brief stair-climbing exercise snacks at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. During each bout, participants will ascend approximately three flights of stairs at a fast but safe self-selected pace for about 20 seconds. Participants will not run or skip steps, and use of the handrail will be permitted as needed.

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
6-Hour Postprandial Glucose Area Under the Curve (AUC)
Tidsramme: From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Plasma glucose will be measured from a fasting venous blood sample obtained before Meal 1 and from serial venous blood samples collected every 30 minutes through 360 minutes after Meal 1 completion. Meal 1 completion will define the start of the postprandial period, and a second standardized meal will be provided at approximately 180 minutes. Plasma glucose AUC will be calculated across the 6-hour experimental period and compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.
From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion
6-Hour Postprandial Plasma Insulin Area Under the Curve (AUC)
Tidsramme: From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Plasma insulin will be measured from a fasting venous blood sample obtained before Meal 1 and from prespecified serial venous blood samples collected through 360 minutes after Meal 1 completion. Meal 1 completion will define time 0, and a second standardized meal will be provided at approximately 180 minutes. Insulin AUC will be calculated across the 0- to 360-minute experimental period and compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.
From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
6-Hour Postprandial Plasma Free Fatty Acid Response
Tidsramme: From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Plasma free fatty acids will be measured from prespecified serial venous blood samples collected during each experimental visit. A fasting baseline sample will be obtained before Meal 1, followed by postprandial sampling through 360 minutes after Meal 1. Free fatty acid responses across the postprandial period will be compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.
From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion
6-Hour Postprandial Plasma Triglyceride Response
Tidsramme: From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Plasma triglycerides will be measured from prespecified serial venous blood samples collected during each experimental visit. A fasting baseline sample will be obtained before Meal 1, followed by postprandial sampling through 360 minutes after Meal 1. Triglyceride responses across the postprandial period will be compared among the three experimental conditions.
From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion
Postprandial Plasma Malondialdehyde (MDA)
Tidsramme: From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Plasma malondialdehyde (MDA), a marker of oxidative stress, will be measured from prespecified venous blood samples collected during each experimental visit. A fasting baseline sample will be obtained before Meal 1, with postprandial assessment through 360 minutes after Meal 1. MDA responses will be compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.
From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion
Postprandial Plasma Inflammatory Cytokines (TNF-α and IL-6)
Tidsramme: From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Plasma tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) will be measured from prespecified venous blood samples collected during each experimental visit. A fasting baseline sample will be obtained before Meal 1, with postprandial assessment through 360 minutes after Meal 1. TNF-α and IL-6 responses will be compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.
From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion
Change in Superficial Femoral Artery Diameter
Tidsramme: Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion

Superficial femoral artery diameter will be assessed using noninvasive Duplex ultrasound before and after each experimental condition. B-mode ultrasound images will be used to quantify arterial diameter, and changes will be compared among uninterrupted sitting, hourly light walking breaks, and hourly stair-climbing exercise snacks.
Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion
Change in Superficial Femoral Artery Blood-Flow Velocity
Tidsramme: Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion

Superficial femoral artery blood-flow velocity will be assessed using Doppler ultrasound before and after each experimental condition. Changes in blood-flow velocity will be compared among uninterrupted sitting, hourly light walking breaks, and hourly stair-climbing exercise snacks.
Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion
Change in Superficial Femoral Artery Shear Pattern
Tidsramme: Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion

Superficial femoral artery shear patterns will be derived from vascular ultrasound measurements obtained before and after each experimental condition. Changes in shear patterns will be compared among uninterrupted sitting, hourly light walking breaks, and hourly stair-climbing exercise snacks.
Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion
Heart Rate Response to Activity Bouts
Tidsramme: Immediately before and immediately after activity bouts at approximately 30, 90, 150, 210, 270, and 330 minutes after Meal 1 completion

Heart rate will be recorded immediately before and immediately after each walking or stair-climbing bout, with measurements obtained at corresponding matched time points during the uninterrupted-sitting condition. Heart rate responses will be compared among the three experimental conditions.
Immediately before and immediately after activity bouts at approximately 30, 90, 150, 210, 270, and 330 minutes after Meal 1 completion
Rating of Perceived Exertion During Activity Bouts
Tidsramme: Immediately after activity bouts at approximately 30, 90, 150, 210, 270, and 330 minutes after Meal 1 completion

Rating of perceived exertion will be assessed using the Borg Rating of Perceived Exertion Scale (6-20) immediately after each walking and stair-climbing bout. Higher scores indicate greater perceived exertion. Ratings will be used to characterize perceived exercise intensity across the active conditions.
Immediately after activity bouts at approximately 30, 90, 150, 210, 270, and 330 minutes after Meal 1 completion
End-of-Study Acceptability and Practicality Questionnaire Responses
Tidsramme: After completion of the final experimental visit, approximately 3 to 6 weeks after enrollment

Participants will complete the RISE UP End-of-Study Acceptability, Practicality, and Potential Adoption Questionnaire after the final experimental visit. Items assess acceptability, enjoyment, practicality, confidence, perceived usefulness, and willingness for future adoption. Agreement items use a 5-point response scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Higher scores indicate greater agreement with the individual statement. Because the questionnaire includes both positively and negatively worded items and no overall score will be calculated, higher scores do not uniformly indicate a better or worse outcome. Individual questionnaire items will be summarized separately.
After completion of the final experimental visit, approximately 3 to 6 weeks after enrollment
Participant-Reported Barriers and Facilitators to Implementation
Tidsramme: After completion of the final experimental visit, approximately 3 to 6 weeks after enrollment

Participants will report perceived barriers and facilitators to implementing brief stair-climbing exercise snacks in daily life using questionnaire items and open-ended responses. Closed-ended barrier items use a 5-point response scale ranging from 1 (Strongly disagree) to 5 (Strongly agree), with higher scores indicating greater agreement that the specified factor represents a barrier. Open-ended responses will be summarized qualitatively. No overall barriers or facilitators score will be calculated.
After completion of the final experimental visit, approximately 3 to 6 weeks after enrollment

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.
St. Louis University

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Hossein Rafiei, PhD, RD, ACSM-CPT, St. Louis University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Anslået)

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.
1. oktober 2026

Primær færdiggørelse (Anslået)

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.
1. juli 2027

Studieafslutning (Anslået)

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.
1. juli 2027

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).
16. 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.
23. 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.
29. 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.
29. 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.
23. 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

Yderligere relevante MeSH-vilkår

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.
  • STUDY00000085
  • PROJ-000884 (Andet bevillings-/finansieringsnummer: Saint Louis University)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying the results reported in the primary publication may be shared upon reasonable request to the Principal Investigator, subject to institutional policies, applicable ethical and privacy requirements, and execution of an appropriate data-use agreement when required.

IPD-delingstidsramme

Beginning 6 months after publication of the primary study results and continuing for 5 years.

IPD-delingsadgangskriterier

De-identified individual participant data underlying the published results and selected supporting materials may be made available to qualified researchers upon reasonable request to the Principal Investigator. Requests should include a scientifically sound proposal describing the planned analyses and intended use of the data. Access will be subject to applicable Saint Louis University policies, ethical and privacy requirements, and execution of a data-use agreement when required. Data will not include direct participant identifiers.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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 .

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