NMES chez les patients atteints d'IC pour améliorer la récupération fonctionnelle après une hospitalisation (NeuHFRecover)
13 mai 2026 mis à jour par: Sherrie Khadanga, University of Vermont Medical Center
Stimulation électrique neuromusculaire chez les patients insuffisants cardiaques pour améliorer la récupération fonctionnelle après une hospitalisation (NeuHF-Recover)
L'objectif de cette étude de recherche est de comprendre si un programme d'exercices à domicile commencé après l'hospitalisation pour HFpEF et poursuivi pendant 4 semaines après la sortie de l'hôpital, peut préserver ou améliorer la fonction physique.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
L'insuffisance cardiaque est la principale cause d'hospitalisation chez les adultes aux États-Unis, les patients présentant une fraction d'éjection préservée (HFpEF) représentant la moitié de ces admissions.
De nombreux patients présentent une fatigue chronique, une intolérance à l'exercice et une incapacité à effectuer les activités de la vie quotidienne, qui est exacerbée par l'hospitalisation.
L'objectif de cette étude de recherche est de comprendre si un programme d'exercices à domicile commencé peu de temps après l'hospitalisation et poursuivi pendant 4 semaines après la sortie peut améliorer la récupération fonctionnelle chez les patients HFpEF.
Les volontaires seront assignés au hasard pour recevoir une stimulation électrique neuromusculaire (NMES) de leurs muscles quadriceps ou pour ne pas recevoir de NMES (groupe témoin).
Les volontaires seront évalués pendant l'hospitalisation et 4 semaines après la sortie.
Les évaluations comprendront des mesures de la fonction physique par un test de marche de 6 minutes et la batterie de performances physiques courtes, ainsi qu'une évaluation de la capacité fonctionnelle physique subjective et de la qualité de vie à l'aide du questionnaire Medical Outcomes Short form 36 et du questionnaire Kansas City Cardiomyopathy.
Type d'étude
Interventionnel
Inscription (Réel)
8
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Vermont
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Burlington, Vermont, États-Unis, 05405
- University of Vermont Medical Center
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
50 ans à 90 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
La description
Critère d'intégration:
- 50-90 ans
- diagnostic clinique de HFpEF activement géré pendant l'hospitalisation
- vivre à moins de 30 miles du centre médical
- capable d'effectuer un consentement éclairé
Critère d'exclusion:
- polyarthrite rhumatoïde ou autre maladie inflammatoire/auto-immune
- cancer, à l'exclusion du cancer de la peau autre que le mélanome ou du cancer de la prostate de bas grade
- démence sévère/maladie d'Alzheimer
- exercice limitant la maladie vasculaire périphérique
- maladie neuromusculaire ou dysfonctionnement neuromusculaire associé à un événement cérébrovasculaire
- indice de masse corporelle ≥40 kg/m2
- caillot sanguin du membre inférieur ou défibrillateur automatique implantable ou stimulateur cardiaque
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Stimulation électrique neuromusculaire
Stimulation électrique neuromusculaire du quadriceps.
45 minutes, 5 jours par semaine
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Stimulation bilatérale des muscles quadriceps
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Aucune intervention: Contrôle
Pas de contrôle du traitement
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Distance de marche de 6 minutes (6 MW)
Délai: Passage de la sortie de l'hôpital (dans un délai d'un jour) à 4 semaines après la sortie
|
6 MW a été développé pour évaluer la condition cardiopulmonaire chez les patients atteints de maladies pulmonaires et cardiaques, et a été validé chez les patients souffrant d'insuffisance cardiaque.
Il évalue la distance qu'un patient peut parcourir en 6 minutes autour d'un parcours standard.
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Passage de la sortie de l'hôpital (dans un délai d'un jour) à 4 semaines après la sortie
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Batterie de performance physique courte
Délai: Passage de la sortie de l'hôpital (dans un délai d'un jour) à 4 semaines après la sortie
|
La batterie de performance physique courte est composée de trois tâches évaluant l'équilibre, la vitesse de marche et la capacité à se tenir debout depuis une chaise.
Les unités sur une échelle pour chaque domaine vont de 0 à 4 pour un score total de 0 à 12, un score plus élevé indiquant une meilleure fonction physique.
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Passage de la sortie de l'hôpital (dans un délai d'un jour) à 4 semaines après la sortie
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Formulaire abrégé des résultats médicaux 36
Délai: Sortie de l'hôpital (dans un délai d'un jour) et 4 semaines après la sortie
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Le formulaire abrégé 36 sur les résultats médicaux est un questionnaire qui évalue l'état de santé et l'état fonctionnel physique autodéclarés.
Il y a 36 questions qui reflètent huit sous-domaines de la santé inclus dans ce questionnaire.
Les scores pour chaque domaine représentent les sommes pondérées des questions dans chaque sous-domaine.
Chaque échelle est directement transformée en une échelle de 0 à 100 en supposant que chaque question a un poids égal.
Cette mesure représente le score total calculé dans tous les sous-domaines.
Les scores les plus faibles représentent une moins bonne santé globale, tandis que les scores les plus élevés représentent une meilleure santé.
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Sortie de l'hôpital (dans un délai d'un jour) et 4 semaines après la sortie
|
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Indice de Katz d'indépendance dans les activités de la vie quotidienne
Délai: Sortie de l'hôpital (dans un délai d'un jour) et 4 semaines après la sortie
|
L'indice d'indépendance de Katz dans les activités de la vie quotidienne, communément appelé ADL de Katz, est l'instrument le plus approprié pour évaluer l'état fonctionnel en tant que mesure de la capacité du client à effectuer les activités de la vie quotidienne de manière autonome.
Les cliniciens utilisent généralement l'outil pour détecter les problèmes dans l'exécution des activités de la vie quotidienne et pour planifier les soins en conséquence.
L'indice classe l'adéquation de la performance dans les six fonctions que sont le bain, l'habillage, la toilette, le transfert, la continence et l'alimentation.
Les clients sont notés oui/non pour l'indépendance dans chacune des six fonctions.
Un score de 6 indique un fonctionnement complet, 4 indique une déficience modérée et 2 ou moins indique une déficience fonctionnelle sévère.
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Sortie de l'hôpital (dans un délai d'un jour) et 4 semaines après la sortie
|
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Lawton Instrumental Activities of Daily Living (IADL) Scale
Délai: 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
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Medical Outcomes Short Form 36 Question 1
Délai: 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
Délai: 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
Délai: 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.
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 3b
Délai: 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
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Medical Outcomes Short Form 36 Question 3c
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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 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
Délai: 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
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Hospital discharge (Within 1 day) and 4-weeks post-discharge
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Medical Outcomes Short Form 36 Question 5c
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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 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
Délai: 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 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
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Medical Outcomes Short Form 36 Question 10c
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
7 février 2022
Achèvement primaire (Réel)
30 septembre 2023
Achèvement de l'étude (Réel)
30 septembre 2023
Dates d'inscription aux études
Première soumission
21 mars 2022
Première soumission répondant aux critères de contrôle qualité
13 avril 2022
Première publication (Réel)
21 avril 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 mai 2026
Dernière vérification
1 avril 2025
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00001757
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .