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NMES i HF-pasienter for å forbedre funksjonell utvinning etter sykehusinnleggelse (NeuHFRecover)

13. mai 2026 oppdatert av: Sherrie Khadanga, University of Vermont Medical Center

Nevromuskulær elektrisk stimulering hos hjertesviktpasienter for å forbedre funksjonell restitusjon etter sykehusinnleggelse (NeuHF-Recover)

Målet med denne forskningsstudien er å forstå om et hjemmetreningsprogram startet etter sykehusinnleggelse for HFpEF, og som fortsetter i 4 uker etter utskrivning fra sykehuset, kan bevare eller forbedre fysisk funksjon.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Hjertesvikt er den ledende årsaken til sykehusinnleggelse blant voksne i USA med pasienter med bevart ejeksjonsfraksjon (HFpEF) som utgjør halvparten av disse innleggelsene. Mange pasienter viser kronisk tretthet, treningsintoleranse og manglende evne til å utføre daglige aktiviteter, noe som forverres av sykehusinnleggelse. Målet med denne forskningsstudien er å forstå om et hjemmetreningsprogram startet like etter sykehusinnleggelse og fortsetter i 4 uker etter utskrivning kan forbedre funksjonell utvinning hos HFpEF-pasienter. Frivillige vil bli tilfeldig tildelt til å motta nevromuskulær elektrisk stimulering (NMES) av quadriceps-musklene eller ikke motta NMES (kontrollgruppe). Frivillige vil bli evaluert under sykehusinnleggelse og 4 uker etter utskrivning. Vurderinger vil inkludere målinger av fysisk funksjon ved 6 minutters gangetest og Short Physical Performance Battery, samt vurdering av subjektiv fysisk funksjonskapasitet og livskvalitet ved bruk av Medical Outcomes Short form 36 og Kansas City Cardiomyopathy spørreskjema.

Studietype

Intervensjonell

Registrering (Faktiske)

8

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Vermont
      • Burlington, Vermont, Forente stater, 05405
        • University of Vermont Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • 50-90 år
  • klinisk diagnose av at HFpEF blir aktivt behandlet under sykehusinnleggelse
  • bor innen 30 miles fra legesenteret
  • i stand til å utføre informert samtykke

Ekskluderingskriterier:

  • revmatoid artritt eller annen inflammatorisk/autoimmun sykdom
  • kreft, unntatt ikke-melanom hudkreft eller lavgradig prostatakreft
  • alvorlig demens/alzheimers sykdom
  • trening som begrenser perifer vaskulær sykdom
  • nevromuskulær sykdom eller nevromuskulær dysfunksjon assosiert med cerebrovaskulær hendelse
  • kroppsmasseindeks ≥40 kg/m2
  • blodpropp i nedre ekstremiteter eller implanterbar kardioverter-defibrillator eller pacemaker

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Neuromuskulær elektrisk stimulering
Nevromuskulær elektrisk stimulering av quadriceps. 45 minutter, 5 dager i uken
Enhet: Neuromuskulær elektrisk stimulering
Bilateral quadriceps muskelstimulering
Ingen inngripen: Kontroll
Ingen behandlingskontroll

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
6 minutters gangavstand (6MW)
Tidsramme: Bytt fra sykehusutskrivning (innen 1 dag) til 4 uker etter utskrivning
6 MW ble utviklet for å vurdere kardiopulmonal kondisjon hos pasienter med lunge- og hjertesykdom, og har blitt validert hos hjertesviktpasienter. Den vurderer avstanden en pasient kan gå på 6 minutter rundt et standardkurs.
Bytt fra sykehusutskrivning (innen 1 dag) til 4 uker etter utskrivning

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Kort fysisk ytelsesbatteri
Tidsramme: Bytt fra sykehusutskrivning (innen 1 dag) til 4 uker etter utskrivning
Short Physical Performance Battery er sammensatt av tre oppgaver som vurderer balanse, ganghastighet og evne til å stå fra en stol. Enheter på en skala for hvert domene varierer fra 0-4 for en total poengsum på 0 til 12, med en høyere poengsum som indikerer bedre fysisk funksjon.
Bytt fra sykehusutskrivning (innen 1 dag) til 4 uker etter utskrivning
Kortskjema for medisinske resultater 36
Tidsramme: Sykehusutskrivning (innen 1 dag) og 4 uker etter utskrivning
The Medical Outcomes Short Form 36 er et spørreskjema som vurderer selvrapportert helse og fysisk funksjonsstatus. Det er 36 spørsmål som reflekterer åtte underdomener av helse inkludert i dette spørreskjemaet. Poeng for hvert domene representerer vektede summer av spørsmålene i hvert underdomene. Hver skala transformeres direkte til en 0-100 skala under forutsetning av at hvert spørsmål har lik vekt. Dette målet representerer den totale beregnede poengsummen på tvers av alle underdomener. Lavere skår representerer dårligere generell helse, mens høyere skår representerer bedre helse.
Sykehusutskrivning (innen 1 dag) og 4 uker etter utskrivning
Katz-indeksen for uavhengighet i dagliglivets aktiviteter
Tidsramme: Sykehusutskrivning (innen 1 dag) og 4 uker etter utskrivning
Katz Index of Independence in Activities of Daily Living, ofte referert til som Katz ADL, er det mest hensiktsmessige instrumentet for å vurdere funksjonsstatus som et mål på klientens evne til å utføre dagliglivets aktiviteter uavhengig. Klinikere bruker vanligvis verktøyet til å oppdage problemer med å utføre daglige aktiviteter og planlegge omsorg deretter. Indeksen rangerer tilstrekkelig ytelse i de seks funksjonene bading, påkledning, toalettbesøk, forflytning, kontinens og fôring. Klienter gis ja/nei for uavhengighet i hver av de seks funksjonene. En score på 6 indikerer full funksjon, 4 indikerer moderat svekkelse og 2 eller mindre indikerer alvorlig funksjonsnedsettelse.
Sykehusutskrivning (innen 1 dag) og 4 uker etter utskrivning
Lawton Instrumental Activities of Daily Living (IADL) Scale
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs. The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering have been excluded. Since men regularly complete food preparation, housekeeping, and laundering tasks, they were scored in all 8 domains as well.

Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and men.
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 1
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
Responses to Q1. In general, would you say your health is:
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 2
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
Responses to Q2. Compared to one year ago, how would you rate your health in general now?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3a
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3a. Vigorous activities, such as running, lifting heavy objects, participating in strenuous sports.
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3b
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3b. Moderate activities, such as moving a table, pushing a vacuum cleaner, bowling, or playing golf.
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3c
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3c. Lifting or carrying groceries.
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3d
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3d. Climbing several flights ofstairs
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3e
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3e. Climbing one flight of stairs
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3f
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3f. Bending, kneeling, or stooping
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3g
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3g. Walking more than a mile
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3h
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3h. Walking several blocks
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3i
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3i. Walking one block
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 3j
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? Responses to Q3j. Bathing or dressing yourself
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 4a
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4a. Cut down the amount of time you spent on work or other activities
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 4b
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4b. Accomplished less than you would like
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 4c
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4c. Were limited in the kind of work or other activities
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 4d
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of your physical health? Responses to Q4d. Had difficulty performing the work or other activities (for example, it took extra effort)
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 5a
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Responses to Q5a. Cut down the amount of time you spent on work or other activities
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 5b
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Responses to Q5b. Accomplished less than you would like
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 5c
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
During the past 4weeks, have you had any of he following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? Responses to Q5c. Didn't do work or other activities as carefully as usual
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 6
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
Responses to Q6. During the past 4weeks, to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors or groups?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 7
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
Responses to Q7. How much bodily pain have you had during the past four weeks?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 8
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
Responses to Q8. During the past 4weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9a
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks...

Responses to Q9a. Did you feel full of pep?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9b
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks...

Responses to Q9b. Have you been a very nervous person?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9c
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks...

Responses to Q9c. Have you felt so down in the dumps that nothing could cheer you up?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9d
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks...

Responses to Q9d. Have you felt calm and peaceful?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9e
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks...

Responses to Q9e. Did you have a lot of energy?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9f
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks...

Responses to Q9f. Have you felt down hearted and blue?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9g
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks...

Responses to Q9g. Did you feel worn out?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9h
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks...

Responses to Q9h. Have you been a happy person?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9i
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks...

Responses to Q9i. Did you feel tired?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 9j
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

These questions are about how you feel and how things have been with you during the past 4weeks. For each question, please give the one answer that comes closest to the way you have been feeling. How much of the time during the past 4weeks...

Responses to Q9j. During the past 4weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)?
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 10a
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

How TRUE or FALSE is each of the following statements for you:

Responses to Q10a. I seem to get sick a little easier than other people
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 10b
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

How TRUE or FALSE is each of the following statements for you:

Responses to Q10b. I am as healthy as anybody I know
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 10c
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

How TRUE or FALSE is each of the following statements for you:

Responses to Q10c. I expect my health to get worse
Hospital discharge (Within 1 day) and 4-weeks post-discharge
Medical Outcomes Short Form 36 Question 10d
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge

How TRUE or FALSE is each of the following statements for you:

Responses to Q10d. My health is excellent
Hospital discharge (Within 1 day) and 4-weeks post-discharge

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Vermont Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. februar 2022

Primær fullføring (Faktiske)

30. september 2023

Studiet fullført (Faktiske)

30. september 2023

Datoer for studieregistrering

Først innsendt

21. mars 2022

Først innsendt som oppfylte QC-kriteriene

13. april 2022

Først lagt ut (Faktiske)

21. april 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2026

Sist bekreftet

1. april 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00001757

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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