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Remote vs In-Person Prehabilitation for Kidney Transplant Candidates (KIDFIT)

8. juli 2026 opdateret af: Hospital Clinic of Barcelona

Implementation of a Multimodal Prehabilitation Program for Patients With Advanced Chronic Kidney Disease Awaiting Deceased-Donor Kidney Transplantation: A Comparison of In-Person and Remote Delivery Models

Patients with advanced chronic kidney disease awaiting deceased-donor kidney transplantation frequently experience progressive functional decline, frailty, reduced mobility, and poor quality of life while on the transplant waiting list. Although multimodal prehabilitation programs based on exercise, nutritional optimization, and psychological support have shown promising benefits in major surgery, their implementation in kidney transplant candidates remains limited due to barriers related to accessibility, fatigue, transportation, and treatment burden.

This randomized single-center clinical trial aims to evaluate the feasibility, adherence, and effectiveness of a multimodal prehabilitation program in patients awaiting deceased-donor kidney transplantation, comparing an in-person supervised model with a remote home-based model supported by a digital platform. The primary outcome will be the change in functional capacity measured by the 6-Minute Walk Test (6MWT). Secondary outcomes include physical activity level, frailty, nutritional status, kidney disease-specific quality of life (KDQOL-36), postoperative recovery quality (QoR-15), postoperative complications, and program adherence.

The study seeks to generate clinically applicable evidence regarding the implementation and scalability of remote prehabilitation strategies in patients with advanced chronic kidney disease, with the potential to improve accessibility, sustainability, and perioperative outcomes in kidney transplantation.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Ikke rekrutterer endnu

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

Patients with advanced chronic kidney disease (CKD) awaiting deceased-donor kidney transplantation frequently experience progressive deterioration in functional capacity, mobility, and quality of life during the waiting-list period. Frailty, sarcopenia, cardiovascular comorbidity, anemia, fatigue, and physical inactivity are highly prevalent in this population and may adversely affect perioperative outcomes, postoperative recovery, and healthcare utilization after transplantation. Reduced cardiorespiratory reserve has been associated with increased postoperative morbidity and poorer clinical outcomes in kidney transplant recipients.

Prehabilitation has emerged as a perioperative optimization strategy aimed at enhancing functional reserve before surgical stress through multimodal interventions that combine structured exercise training, nutritional optimization, and psychological support. Previous studies in major surgery and solid organ transplantation suggest that prehabilitation may improve exercise tolerance, physical functioning, postoperative recovery, and patient-reported outcomes. However, implementation of prehabilitation programs in patients with advanced CKD remains limited because of barriers related to dialysis schedules, transportation burden, fatigue, reduced mobility, and limited access to specialized hospital-based programs.

Remote or home-based prehabilitation models supported by digital technologies may improve accessibility, adherence, and scalability while maintaining clinical effectiveness. Nevertheless, evidence comparing remote and in-person multimodal prehabilitation strategies in kidney transplant candidates remains scarce.

This study is a prospective randomized single-center clinical trial designed to evaluate the feasibility, adherence, and effectiveness of a multimodal prehabilitation program in adult patients with advanced CKD awaiting deceased-donor kidney transplantation. Participants will be randomized in a 1:1 ratio to either an in-person supervised prehabilitation program or a remote home-based program delivered through a digital platform.

Both intervention groups will receive the same multimodal components, differing only in the delivery format. The intervention includes structured individualized exercise training combining aerobic exercise, strength training, mobility, and balance exercises; individualized nutritional counseling focused on optimization of protein-energy status and prevention of sarcopenia; and psychological support aimed at stress management, motivation, and behavioral reinforcement.

During the initial 8-week intervention phase, participants assigned to the in-person group will attend supervised exercise sessions at the hospital gym three times per week. Participants assigned to the remote group will perform supervised online exercise sessions through the Surgifit® digital platform three times per week in small groups. Following completion of the structured phase, both groups will continue with a personalized community-based physical activity program until transplantation.

All participants will receive access to the Surgifit® platform, which provides educational resources, exercise guidance, nutritional recommendations, healthy recipes, and mindfulness activities. The platform will also facilitate monitoring of adherence and remote supervision of exercise sessions.

Functional, nutritional, frailty, psychological, and quality-of-life assessments will be performed at baseline, at 8 weeks, and at 6 months if transplantation has not yet occurred. Postoperative recovery and clinical outcomes will be assessed in patients undergoing transplantation during the study period.

The primary outcome measure of the study is the change in functional capacity measured by the 6-Minute Walk Test (6MWT). Secondary outcome measures include adherence to the intervention, habitual physical activity level, frailty measures, nutritional status, body composition, kidney disease-specific quality of life, postoperative quality of recovery, postoperative complications, and healthcare utilization outcomes.

The study also incorporates an implementation-oriented framework focused on feasibility, adherence, accessibility, and scalability of multimodal prehabilitation in advanced CKD. Additional exploratory analyses will evaluate patient-perceived barriers and facilitators to participation through questionnaires and qualitative assessments. Environmental and organizational sustainability indicators associated with remote delivery models, including reduction in transportation-related burden and accessibility for patients living far from the transplant center, will also be explored.

The trial is expected to generate clinically applicable evidence regarding the integration of multimodal prehabilitation programs in kidney transplant candidates and to inform future patient-centered and scalable perioperative optimization strategies for patients with advanced chronic kidney disease.

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.
84

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.
  • Navn: Beatriz Tena, MD, PhD
  • Telefonnummer: +34625193128
  • E-mail: btena@clinic.cat

Studiesteder

  • Spanien
    • Barcelona
      • Barcelona, Barcelona, Spanien, 08036
        • Hospital Clinic Barcelona
        • Kontakt:
          • Graciela Martínez-Pallí, MD, PhD
          • Telefonnummer: +34932275558
          • E-mail: gmartin@clinic.cat
        • Ledende efterforsker:
          • Beatriz Tena, MD, PhD
        • Underforsker:
          • Graciela Martínez-Pallí, MD, PhD
        • Underforsker:
          • Antonio López, MD
        • Underforsker:
          • Fritz Diekman, MD, PhD
        • Underforsker:
          • Alicia Molina, MD
        • Underforsker:
          • Arana Carolt, MD, PhD
        • Underforsker:
          • Marta Arias, MD, PhD
        • Underforsker:
          • Enrique Montagud, MD
        • Underforsker:
          • Mireia Musquera, MD, PhD
        • Underforsker:
          • Fernando Dana, RN
        • Underforsker:
          • Raquel Sebio-Garcia, PT, PhD
        • Underforsker:
          • Anna Yuguero, PT
        • Underforsker:
          • Barbara Romano, RD
        • Underforsker:
          • Miguel Garriz, PsyD
        • Underforsker:
          • Yolanda Amarilla, RN
        • Underforsker:
          • Sonia Perea, RN
        • Underforsker:
          • Ana María Pérez, RN

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
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Patients with advanced chronic kidney disease on the waiting list for deceased-donor kidney transplantation.
  • Ability to perform moderate-intensity physical exercise.
  • Able and willing to provide written informed consent.

Exclusion Criteria:

  • Absolute contraindication to physical exercise.
  • Severe cognitive impairment limiting participation in the intervention or assessments.
  • Active infection at the time of enrollment.
  • Clinically unstable medical condition.
  • Physical or musculoskeletal limitations preventing participation in the exercise program.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • 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: In-Person Multimodal Prehabilitation
Behavioral: In-Person Multimodal Prehabilitation
Adfærdsmæssigt: In-Person Multimodal Prehabilitation
Participants will receive an 8-week supervised multimodal prehabilitation program including moderate-to-high intensity aerobic exercise, strength training, mobility, and balance exercises performed three times per week at the hospital gym under physiotherapist supervision. The intervention also includes individualized nutritional counseling focused on optimization of protein-energy status and prevention of sarcopenia, as well as psychological support aimed at motivation and stress management. After the supervised phase, participants will continue with a personalized community-based physical activity program until kidney transplantation.
Eksperimentel: Remote Multimodal Prehabilitation
Behavioral: Remote Multimodal Prehabilitation
Adfærdsmæssigt: Remote Multimodal Prehabilitation
Participants will receive an 8-week remote multimodal prehabilitation program including supervised online exercise sessions performed three times per week through the Surgifit® digital platform. The exercise program includes aerobic exercise, strength training, mobility, and balance exercises adapted to the participant's functional status. Participants will also receive individualized nutritional counseling and psychological support focused on motivation and stress management. After the supervised phase, participants will continue with a personalized community-based physical activity program until kidney transplantation.

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
Change in functional capacity measured by the 6-Minute Walk Test (6MWT)
Tidsramme: Baseline and 8 weeks
Change in walking distance (meters) between baseline and post-intervention assessment measured using the 6-Minute Walk Test.
Baseline and 8 weeks
Kidney disease-specific quality of life (KDQOL-36)
Tidsramme: Baseline, 8 weeks, and 6 months
Change in quality-of-life scores measured using the Kidney Disease Quality of Life-36 questionnaire. Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life, including fewer kidney disease-related symptoms, less burden of kidney disease, and less interference of kidney disease with daily life.
Baseline, 8 weeks, and 6 months

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
Program adherence
Tidsramme: 8 weeks
Percentage of scheduled exercise sessions completed during the supervised intervention period.
8 weeks
Physical activity level
Tidsramme: Baseline, 8 weeks, and 6 months
Physical activity assessed using the Yale Physical Activity Survey (YPAS). The YPAS is a questionnaire designed to assess physical activity levels in older adults. The survey generates summary indices of physical activity, with higher scores indicating greater levels of physical activity. There is no fixed theoretical minimum or maximum.
Baseline, 8 weeks, and 6 months
Functional mobility (Timed Up and Go Test)
Tidsramme: Baseline, 8 weeks, and 6 months
Functional mobility assessed using the Timed Up and Go Test. It assesses functional mobility by measuring the time required to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Scores are expressed in seconds, with lower scores indicating better functional mobility and physical performance, and higher scores indicating worse mobility. There is no fixed maximum.
Baseline, 8 weeks, and 6 months
Frailty status
Tidsramme: Baseline, 8 weeks, and 6 months
Frailty assessed using the Clinical Frailty Scale (CFS). The CFS is a 9-point global measure of frailty ranging from 1 (very fit) to 9 (terminally ill). Higher scores indicate greater frailty and worse overall health status.
Baseline, 8 weeks, and 6 months
Handgrip strength
Tidsramme: Baseline, 8 weeks, and 6 months
Handgrip strength was measured using a handheld dynamometer and expressed in kilograms (kg). The measure has no fixed minimum or maximum value. Higher values indicate greater muscle strength and generally a better outcome.
Baseline, 8 weeks, and 6 months
Nutritional status
Tidsramme: Baseline, 8 weeks, and 6 months
Nutritional status assessed according to Global Leadership Initiative on Malnutrition (GLIM) criteria.
Baseline, 8 weeks, and 6 months
Lean body mass
Tidsramme: Baseline, 8 weeks, and 6 months
Lean Body Mass (%), assessed by bioelectrical impedance analysis (BIA), ranges from 0% to 100%, with higher values indicating a greater proportion of lean tissue relative to total body weight.
Baseline, 8 weeks, and 6 months
Phase angle
Tidsramme: Baseline, 8 weeks and 6 months
Phase Angle (PhA) was assessed using bioelectrical impedance analysis (BIA) and expressed in degrees (°). The measure has no fixed minimum or maximum value. Higher values indicate better cellular health, membrane integrity, and nutritional status, whereas lower values are associated with poorer nutritional and functional status.
Baseline, 8 weeks and 6 months
Anxiety and depression symptoms
Tidsramme: Baseline, 8 weeks, and 6 months
Symptoms assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item questionnaire comprising two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D). Subscale scores range from 0 to 21, and the total score ranges from 0 to 42. Higher scores indicate greater symptoms of anxiety and depression and therefore a worse outcome.
Baseline, 8 weeks, and 6 months
Anxiety related to surgery
Tidsramme: Baseline, 8 weeks, and 6 months
Preoperative anxiety assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The APAIS is a 6-item questionnaire assessing preoperative anxiety and need for information. The anxiety subscale ranges from 4 to 20, and the information subscale ranges from 2 to 10. The total score ranges from 6 to 30. Higher scores indicate greater preoperative anxiety and/or greater need for information.
Baseline, 8 weeks, and 6 months
Postoperative quality of recovery
Tidsramme: Postoperative day 5 and postoperative day 30
Quality of postoperative recovery assessed using the Quality of Recovery-15 questionnaire (QoR-15). The QoR-15 is a 15-item patient-reported outcome measure assessing postoperative recovery across multiple domains, including physical comfort, emotional state, physical independence, psychological support, and pain. Total scores range from 0 to 150, with higher scores indicating better quality of recovery and a better postoperative outcome.
Postoperative day 5 and postoperative day 30
Postoperative complications
Tidsramme: Within 30 days after transplantation
Overall burden of postoperative complications assessed using the Comprehensive Complication Index (CCI).
Within 30 days after transplantation
Lenght of postoperative hospital stay
Tidsramme: From surgery to hospital discharge, assessed up to 30 days postoperatively.
Length of Postoperative Hospital Stay is defined as the number of days from surgery until hospital discharge. The measure has no fixed minimum or maximum value. Lower values indicate a shorter postoperative hospitalization and generally a better outcome.
From surgery to hospital discharge, assessed up to 30 days postoperatively.
Intensive care unit admission
Tidsramme: From surgery through hospital discharge, assessed up to 30 days.
Requirement for intensive care unit admission after kidney transplantation during hospital stay.
From surgery through hospital discharge, assessed up to 30 days.
Length of Intensive Care Unit (ICU) Stay
Tidsramme: From ICU admission to ICU discharge, assessed up to 30 days
Length of Intensive Care Unit (ICU) Stay was defined as the time from ICU admission to ICU discharge and was expressed in days (or hours). The measure has no fixed minimum or maximum value. Lower values indicate a shorter ICU stay and generally a better outcome
From ICU admission to ICU discharge, assessed up to 30 days

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.
Hospital Clinic of Barcelona

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

Hjælpsomme links

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. juli 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. maj 2028

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. maj 2029

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).
27. maj 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.
8. juli 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.
14. juli 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. juli 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.
8. juli 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. maj 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.
  • HCB/2026/0063

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

De-identified individual participant data (IPD) underlying the published results, including demographic, clinical, functional, and patient-reported outcome data collected during the study, may be shared upon reasonable request to the principal investigator after publication of the primary results. Data sharing will be considered for methodologically sound research proposals and following approval by the study investigators and institutional policies. All shared data will be fully anonymized in accordance with applicable data protection regulations. Supporting documents such as the study protocol, statistical analysis plan, and informed consent form may also be made available upon request.

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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