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NMES nei pazienti con scompenso cardiaco per migliorare il recupero funzionale dopo il ricovero (NeuHFRecover)

13 maggio 2026 aggiornato da: Sherrie Khadanga, University of Vermont Medical Center

Stimolazione elettrica neuromuscolare nei pazienti con scompenso cardiaco per migliorare il recupero funzionale dopo il ricovero (NeuHF-Recover)

L'obiettivo di questo studio di ricerca è capire se un programma di esercizi a casa iniziato dopo il ricovero per HFpEF e continuato per 4 settimane dopo la dimissione dall'ospedale, può preservare o migliorare la funzione fisica.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

L'insufficienza cardiaca è la principale causa di ospedalizzazione tra gli adulti negli Stati Uniti con pazienti con frazione di eiezione conservata (HFpEF) che rappresentano la metà di tali ricoveri. Molti pazienti mostrano stanchezza cronica, intolleranza all'esercizio e incapacità di svolgere le attività della vita quotidiana, che è esacerbata dal ricovero in ospedale. L'obiettivo di questo studio di ricerca è capire se un programma di esercizi a casa iniziato subito dopo il ricovero e continuato per 4 settimane dopo la dimissione può migliorare il recupero funzionale nei pazienti con HFpEF. I volontari saranno assegnati in modo casuale a ricevere la stimolazione elettrica neuromuscolare (NMES) dei loro muscoli quadricipiti o a non ricevere NMES (gruppo di controllo). I volontari saranno valutati durante il ricovero e 4 settimane dopo la dimissione. Le valutazioni includeranno misurazioni della funzione fisica mediante il test del cammino di 6 minuti e la batteria delle prestazioni fisiche brevi, nonché la valutazione della capacità funzionale fisica soggettiva e della qualità della vita utilizzando il modulo 36 dei risultati medici e il questionario sulla cardiomiopatia di Kansas City.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

8

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Vermont
      • Burlington, Vermont, Stati Uniti, 05405
        • University of Vermont Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 50 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • 50-90 anni
  • diagnosi clinica di HFpEF gestita attivamente durante il ricovero
  • vivere entro 30 miglia dal centro medico
  • in grado di prestare il consenso informato

Criteri di esclusione:

  • artrite reumatoide o altra malattia infiammatoria/autoimmune
  • cancro, escluso il cancro della pelle non melanoma o il cancro alla prostata di basso grado
  • grave demenza/malattia di Alzheimer
  • esercizio che limita la malattia vascolare periferica
  • malattia neuromuscolare o disfunzione neuromuscolare associata a evento cerebrovascolare
  • indice di massa corporea ≥40 kg/m2
  • coagulo di sangue degli arti inferiori o defibrillatore cardioverter impiantabile o pacemaker

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Stimolazione elettrica neuromuscolare
Stimolazione elettrica neuromuscolare del quadricipite. 45 minuti, 5 giorni a settimana
Dispositivo: Stimolazione elettrica neuromuscolare
Stimolazione muscolare quadricipitale bilaterale
Nessun intervento: Controllo
Nessun controllo del trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Distanza a piedi di 6 minuti (6MW)
Lasso di tempo: Passaggio dalla dimissione ospedaliera (entro 1 giorno) a 4 settimane dopo la dimissione
6 MW è stato sviluppato per valutare l'idoneità cardiopolmonare in pazienti con malattie polmonari e cardiache ed è stato convalidato in pazienti con insufficienza cardiaca. Valuta la distanza che un paziente può percorrere in 6 minuti in un percorso standard.
Passaggio dalla dimissione ospedaliera (entro 1 giorno) a 4 settimane dopo la dimissione

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Batteria con prestazioni fisiche ridotte
Lasso di tempo: Passaggio dalla dimissione ospedaliera (entro 1 giorno) a 4 settimane dopo la dimissione
La batteria delle prestazioni fisiche brevi è composta da tre compiti che valutano l'equilibrio, la velocità dell'andatura e la capacità di alzarsi da una sedia. Le unità su una scala per ogni dominio vanno da 0 a 4 per un punteggio totale da 0 a 12, con un punteggio più alto che indica una migliore funzione fisica.
Passaggio dalla dimissione ospedaliera (entro 1 giorno) a 4 settimane dopo la dimissione
Risultati medici Modulo breve 36
Lasso di tempo: Dimissione dall'ospedale (entro 1 giorno) e 4 settimane dopo la dimissione
Il Medical Outcomes Short Form 36 è un questionario che valuta la salute autodichiarata e lo stato funzionale fisico. Ci sono 36 domande che riflettono otto sottodomini della salute inclusi in questo questionario. I punteggi per ciascun dominio rappresentano le somme ponderate delle domande in ciascun sottodominio. Ogni scala viene trasformata direttamente in una scala da 0 a 100 partendo dal presupposto che ogni domanda abbia lo stesso peso. Questa misura rappresenta il punteggio totale calcolato in tutti i sottodomini. I punteggi più bassi rappresentano una salute generale peggiore, mentre i punteggi più alti rappresentano una salute migliore.
Dimissione dall'ospedale (entro 1 giorno) e 4 settimane dopo la dimissione
Indice Katz di indipendenza nelle attività della vita quotidiana
Lasso di tempo: Dimissione dall'ospedale (entro 1 giorno) e 4 settimane dopo la dimissione
Il Katz Index of Independence in Activities of Daily Living, comunemente indicato come Katz ADL, è lo strumento più appropriato per valutare lo stato funzionale come misura della capacità del cliente di svolgere autonomamente le attività della vita quotidiana. I medici in genere utilizzano lo strumento per rilevare problemi nello svolgimento delle attività della vita quotidiana e per pianificare le cure di conseguenza. L'indice classifica l'adeguatezza delle prestazioni nelle sei funzioni di lavarsi, vestirsi, andare in bagno, trasferirsi, continenza e nutrirsi. Ai clienti viene assegnato un punteggio sì/no per l'indipendenza in ciascuna delle sei funzioni. Un punteggio di 6 indica la piena funzionalità, 4 indica una compromissione moderata e 2 o meno indica una grave compromissione funzionale.
Dimissione dall'ospedale (entro 1 giorno) e 4 settimane dopo la dimissione
Lawton Instrumental Activities of Daily Living (IADL) Scale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Vermont Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 febbraio 2022

Completamento primario (Effettivo)

30 settembre 2023

Completamento dello studio (Effettivo)

30 settembre 2023

Date di iscrizione allo studio

Primo inviato

21 marzo 2022

Primo inviato che soddisfa i criteri di controllo qualità

13 aprile 2022

Primo Inserito (Effettivo)

21 aprile 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 maggio 2026

Ultimo verificato

1 aprile 2025

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00001757

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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