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Prova pilota di riabilitazione del nucleo addominale per migliorare i risultati dopo la riparazione dell'ernia ventrale (ABVENTURE-P)

7 maggio 2026 aggiornato da: Ajit Chaudhari, Ohio State University
Questo studio mira a valutare il ruolo potenziale della terapia fisica nel migliorare i risultati dopo la riparazione dell'ernia ventrale.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Dopo essere stati informati sullo studio e sui potenziali rischi, tutti i pazienti che danno il consenso informato scritto eseguiranno valutazioni di diverse attività della vita quotidiana e completeranno diversi sondaggi che descrivono in dettaglio le loro capacità pre-chirurgiche, qualità della vita e dolore. Immediatamente dopo la loro procedura chirurgica, i pazienti saranno randomizzati in modo singolo cieco (ricercatore) in un rapporto 1: 1 alla terapia fisica supervisionata (8 settimane, due volte alla settimana) o precauzioni post-chirurgiche standard. Le valutazioni e le indagini saranno ripetute dall'investigatore in cieco a 30 giorni, 10 settimane, 6 mesi e 1 anno dopo l'intervento chirurgico.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

138

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
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43210
        • Ohio State University Wexner 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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione

  • Età 18+
  • Diagnosi di ernia ventrale
  • In programma per la riparazione elettiva dell'ernia ventrale
  • Stato funzionale indipendente
  • Larghezza dell'ernia trasversale di 2 cm o superiore

Criteri di esclusione

  • Disturbo del movimento o dell'equilibrio precedentemente diagnosticato
  • Uso di dispositivi di assistenza ambulatoriale (deambulatore o bastone)
  • Attualmente non sottoposto o in programma di sottoporsi a terapia fisica o altro intervento di esercizio qualificato sotto la supervisione di un professionista della riabilitazione medica

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: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Istruzioni post-operatorie standard
Ai partecipanti al gruppo di controllo verrà detto al momento della dimissione postoperatoria che devono seguire le istruzioni postoperatorie.
Altro: Precauzioni post-operatorie
Questo intervento include istruzioni post-operatorie standard di cura generalmente fornite ai pazienti sottoposti a riparazione di ernia ventrale in tutto il mondo. Questi includono la limitazione dell'attività fisica intensa e una restrizione di sollevamento di non più di 10 libbre per 6 settimane. L'uso del legante è incoraggiato anche per 4-6 settimane dopo l'operazione.
Sperimentale: Terapia fisica supervisionata
I partecipanti al gruppo di terapia fisica saranno programmati per le visite alla clinica di terapia fisica a partire da due settimane dopo l'intervento chirurgico e saranno sottoposti a trattamenti di terapia fisica supervisionati circa due volte a settimana per otto settimane secondo una riabilitazione post-operatoria basata sull'evidenza standardizzata della chirurgia del nucleo addominale programma.
Altro: Terapia fisica supervisionata
Il ciclo di 8 settimane di fisioterapia supervisionata due volte a settimana inizia 2 settimane dopo l'intervento chirurgico. Si rivolge alla funzione del nucleo addominale attraverso il progressivo riaddestramento e rafforzamento dei muscoli e la postura specifica del paziente e l'educazione alla meccanica del corpo.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Five Times Sit-to-stand Time
Lasso di tempo: Baseline before surgery, 10 weeks after surgery
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.
Baseline before surgery, 10 weeks after surgery
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Lasso di tempo: Baseline before surgery, 10 weeks after surgery
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
Baseline before surgery, 10 weeks after surgery
Change From Baseline in Quiet Unstable Sitting Test
Lasso di tempo: Baseline before surgery, 10 weeks after surgery
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.
Baseline before surgery, 10 weeks after surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Hernia Related Quality of Life Survey From Baseline
Lasso di tempo: baseline before surgery, 10 weeks after surgery
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
baseline before surgery, 10 weeks after surgery
Change in Timed Up-And-Go Time From Baseline
Lasso di tempo: baseline before surgery, 10 weeks after surgery
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.
baseline before surgery, 10 weeks after surgery
Change From Baseline in International Physical Activity Questionnaire - Short Form
Lasso di tempo: baseline before surgery, 10 weeks after surgery
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
baseline before surgery, 10 weeks after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Lasso di tempo: baseline before surgery, 10 weeks after surgery
Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.
baseline before surgery, 10 weeks after surgery
Number of Participants With Hernia Recurrence Using the Hernia Recurrence Inventory
Lasso di tempo: 1 year after surgery
Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge. A recurrence is determined by if the patient reports thinking the hernia has come back, feeling or seeing a bulge, or having pain or symptoms at the site. A positive response to any of these 3 questions is considered a recurrence. A recurrence is considered a suboptimal outcome.
1 year after surgery
Change in Hernia Related Quality of Life Survey From Baseline
Lasso di tempo: baseline before surgery, 1 year after surgery
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
baseline before surgery, 1 year after surgery
Change in Timed Up-And-Go Time From Baseline
Lasso di tempo: baseline before surgery, 1 year after surgery
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.
baseline before surgery, 1 year after surgery
Change From Baseline in International Physical Activity Questionnaire - Long Form
Lasso di tempo: baseline before surgery, 1 year after surgery
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
baseline before surgery, 1 year after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Lasso di tempo: baseline before surgery, 1 year after surgery
Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.
baseline before surgery, 1 year after surgery
Change From Baseline in Five Times Sit-to-stand Time
Lasso di tempo: baseline before surgery, 1 year after surgery
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.
baseline before surgery, 1 year after surgery
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Lasso di tempo: baseline before surgery, 1 year after surgery
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
baseline before surgery, 1 year after surgery
Change From Baseline in Quiet Unstable Sitting Test
Lasso di tempo: baseline before surgery, 1 year after surgery
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.
baseline before surgery, 1 year after surgery

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Hernia Related Quality of Life Survey From Baseline
Lasso di tempo: baseline before surgery, 30 days after surgery
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
baseline before surgery, 30 days after surgery
Change in Timed Up-And-Go Time From Baseline
Lasso di tempo: baseline before surgery, 30 days after surgery
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.
baseline before surgery, 30 days after surgery
Change From Baseline in International Physical Activity Questionnaire - Short Form
Lasso di tempo: baseline before surgery, 30 days after surgery
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
baseline before surgery, 30 days after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Lasso di tempo: baseline before surgery, 30 days after surgery
Self-reported 11-question survey on how fear affects desire and ability to perform physical activities. Scores range from 11 (lowest) to 44 (highest). Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.
baseline before surgery, 30 days after surgery
Change From Baseline in Five Times Sit-to-stand Time
Lasso di tempo: baseline before surgery, 30 days after surgery
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.
baseline before surgery, 30 days after surgery
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Lasso di tempo: baseline before surgery, 30 days after surgery
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
baseline before surgery, 30 days after surgery
Change From Baseline in Quiet Unstable Sitting Test
Lasso di tempo: baseline before surgery, 30 days after surgery
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.
baseline before surgery, 30 days after surgery
Change in Hernia Related Quality of Life Survey From Baseline
Lasso di tempo: baseline before surgery, 6 months after surgery
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
baseline before surgery, 6 months after surgery
Change in Timed Up-And-Go Time From Baseline
Lasso di tempo: baseline before surgery, 6 months after surgery
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely. The test is scored in seconds, and a lower time indicates better mobility.
baseline before surgery, 6 months after surgery
Change From Baseline in International Physical Activity Questionnaire - Long Form
Lasso di tempo: baseline before surgery, 6 months after surgery
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity. The test is scored in Metabolic Equivalent of Task (MET)-minutes per week. More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
baseline before surgery, 6 months after surgery
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Lasso di tempo: baseline before surgery, 6 months after surgery
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health. The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
baseline before surgery, 6 months after surgery
Change From Baseline in Five Times Sit-to-stand Time
Lasso di tempo: baseline before surgery, 6 months after surgery
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.
baseline before surgery, 6 months after surgery
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Lasso di tempo: baseline before surgery, 6 months after surgery
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
baseline before surgery, 6 months after surgery
Change From Baseline in Quiet Unstable Sitting Test
Lasso di tempo: baseline before surgery, 6 months after surgery
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.
baseline before surgery, 6 months after surgery

Collaboratori e investigatori

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

Sponsor

Ohio State University

Collaboratori

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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)

19 aprile 2022

Completamento primario (Effettivo)

18 febbraio 2025

Completamento dello studio (Effettivo)

23 dicembre 2025

Date di iscrizione allo studio

Primo inviato

3 novembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

19 novembre 2021

Primo Inserito (Effettivo)

2 dicembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2021H0336
  • R01DK131207 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

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

NO

Descrizione del piano IPD

Solo i dati resi anonimi saranno condivisi con altri ricercatori.

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

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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