NMES hos HF-patienter for at forbedre funktionel restitution efter hospitalsindlæggelse (NeuHFRecover)
13. maj 2026 opdateret af: Sherrie Khadanga, University of Vermont Medical Center
Neuromuskulær elektrisk stimulation hos hjertesvigtpatienter for at forbedre funktionel restitution efter hospitalsindlæggelse (NeuHF-Recover)
Målet med denne forskningsundersøgelse er at forstå, om et hjemmetræningsprogram startet efter indlæggelse for HFpEF og fortsætter i 4 uger efter udskrivelse fra hospitalet, kan bevare eller forbedre den fysiske funktion.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Hjertesvigt er den førende årsag til hospitalsindlæggelse blandt voksne i USA, hvor patienter med bevaret ejektionsfraktion (HFpEF) udgør halvdelen af disse indlæggelser.
Mange patienter udviser kronisk træthed, træningsintolerance og manglende evne til at udføre daglige aktiviteter, hvilket forværres af hospitalsindlæggelse.
Målet med denne forskningsundersøgelse er at forstå, om et hjemmetræningsprogram startet kort efter hospitalsindlæggelse og fortsætter i 4 uger efter udskrivelse kan forbedre funktionel restitution hos HFpEF-patienter.
Frivillige vil blive tilfældigt tildelt til at modtage neuromuskulær elektrisk stimulation (NMES) af deres quadriceps muskler eller ikke at modtage NMES (kontrolgruppe).
Frivillige vil blive evalueret under indlæggelse og 4 uger efter udskrivelse.
Vurderinger vil omfatte målinger af fysisk funktion ved 6 minutters gangtest og Short Physical Performance Battery, samt vurdering af subjektiv fysisk funktionel kapacitet og livskvalitet ved hjælp af Medical Outcomes Short form 36 og Kansas City Cardiomyopathy spørgeskema.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
8
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Vermont
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Burlington, Vermont, Forenede Stater, 05405
- University of Vermont Medical Center
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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
Aldre berettiget til at studere
50 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- 50-90 år
- klinisk diagnose af HFpEF, der aktivt håndteres under indlæggelse
- bor inden for 30 miles fra lægehuset
- i stand til at udføre informeret samtykke
Ekskluderingskriterier:
- reumatoid arthritis eller anden inflammatorisk/autoimmun sygdom
- kræft, eksklusive ikke-melanom hudkræft eller lavgradig prostatacancer
- svær demens/alzheimers sygdom
- træningsbegrænsende perifer vaskulær sygdom
- neuromuskulær sygdom eller neuromuskulær dysfunktion forbundet med cerebrovaskulær hændelse
- kropsmasseindeks ≥40 kg/m2
- blodprop i nedre ekstremiteter eller implanterbar cardioverter-defibrillator eller pacemaker
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Neuromuskulær elektrisk stimulation
Neuromuskulær elektrisk stimulation af quadriceps.
45 minutter, 5 dage om ugen
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Bilateral quadriceps muskelstimulering
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Ingen indgriben: Styring
Ingen behandlingskontrol
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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6 minutters gangafstand (6MW)
Tidsramme: Skift fra hospitalsudskrivning (inden for 1 dag) til 4 uger efter udskrivelsen
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6 MW blev udviklet til at vurdere kardiopulmonal kondition hos patienter med lunge- og hjertesygdomme og er blevet valideret hos patienter med hjertesvigt.
Den vurderer den distance, som en patient kan gå på 6 minutters tid omkring et standardforløb.
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Skift fra hospitalsudskrivning (inden for 1 dag) til 4 uger efter udskrivelsen
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Kort fysisk ydeevne batteri
Tidsramme: Skift fra hospitalsudskrivning (inden for 1 dag) til 4 uger efter udskrivelsen
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Short Physical Performance Battery er sammensat af tre opgaver, der vurderer balance, ganghastighed og evnen til at stå fra en stol.
Enheder på en skala for hvert domæne spænder fra 0-4 for en samlet score på 0 til 12, med en højere score, der indikerer bedre fysisk funktion.
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Skift fra hospitalsudskrivning (inden for 1 dag) til 4 uger efter udskrivelsen
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Kortformular for medicinske resultater 36
Tidsramme: Hospitalsudskrivning (inden for 1 dag) og 4 uger efter udskrivelsen
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Medical Outcomes Short Form 36 er et spørgeskema, der vurderer selvrapporteret helbred og fysisk funktionsstatus.
Der er 36 spørgsmål, der afspejler otte underdomæner af sundhed inkluderet i dette spørgeskema.
Score for hvert domæne repræsenterer vægtede summer af spørgsmålene i hvert underdomæne.
Hver skala omdannes direkte til en 0-100 skala under den antagelse, at hvert spørgsmål vejer lige meget.
Dette mål repræsenterer den samlede beregnede score på tværs af alle underdomæner.
Lavere score repræsenterer dårligere generel sundhed, mens højere score repræsenterer bedre sundhed.
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Hospitalsudskrivning (inden for 1 dag) og 4 uger efter udskrivelsen
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Katz indeks over uafhængighed i daglige aktiviteter
Tidsramme: Hospitalsudskrivning (inden for 1 dag) og 4 uger efter udskrivelsen
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Katz Index of Independence in Activities of Daily Living, almindeligvis omtalt som Katz ADL, er det mest egnede instrument til at vurdere funktionel status som et mål for klientens evne til at udføre aktiviteter i dagliglivet uafhængigt.
Klinikere bruger typisk værktøjet til at opdage problemer med at udføre aktiviteter i dagligdagen og til at planlægge pleje i overensstemmelse hermed.
Indekset rangerer tilstrækkeligheden af ydeevne i de seks funktioner som badning, påklædning, toiletbesøg, forflytning, kontinens og fodring.
Klienter bedømmes ja/nej for uafhængighed i hver af de seks funktioner.
En score på 6 indikerer fuld funktion, 4 indikerer moderat svækkelse, og 2 eller mindre indikerer alvorlig funktionsnedsættelse.
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Hospitalsudskrivning (inden for 1 dag) og 4 uger efter udskrivelsen
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Lawton Instrumental Activities of Daily Living (IADL) Scale
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Medical Outcomes Short Form 36 Question 1
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q1.
In general, would you say your health is:
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 2
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q2.
Compared to one year ago, how would you rate your health in general now?
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Medical Outcomes Short Form 36 Question 3b
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Medical Outcomes Short Form 36 Question 3c
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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.
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3d
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3e
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3f
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
|
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Medical Outcomes Short Form 36 Question 3h
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3i
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3j
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 4a
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 4b
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 4c
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
|
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Medical Outcomes Short Form 36 Question 4d
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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)
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 5b
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
|
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Medical Outcomes Short Form 36 Question 5c
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 6
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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?
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 7
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q7.
How much bodily pain have you had during the past four weeks?
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 8
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Responses to Q8.
During the past 4weeks, how much did pain interfere with your normal work (including both work outside the home and housework)?
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 9a
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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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
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Medical Outcomes Short Form 36 Question 9c
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Medical Outcomes Short Form 36 Question 9d
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Medical Outcomes Short Form 36 Question 9e
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Medical Outcomes Short Form 36 Question 9f
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
|
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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
|
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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
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Medical Outcomes Short Form 36 Question 9i
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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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
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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
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Medical Outcomes Short Form 36 Question 10b
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Medical Outcomes Short Form 36 Question 10c
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Medical Outcomes Short Form 36 Question 10d
Tidsramme: Hospital discharge (Within 1 day) and 4-weeks post-discharge
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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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
7. februar 2022
Primær færdiggørelse (Faktiske)
30. september 2023
Studieafslutning (Faktiske)
30. september 2023
Datoer for studieregistrering
Først indsendt
21. marts 2022
Først indsendt, der opfyldte QC-kriterier
13. april 2022
Først opslået (Faktiske)
21. april 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. maj 2026
Sidst verificeret
1. april 2025
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00001757
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
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produkt fremstillet i og eksporteret fra U.S.A.
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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