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Pilotversuch zur Rehabilitation des Bauchkerns zur Verbesserung der Ergebnisse nach der Reparatur ventraler Hernien (ABVENTURE-P)

7. Mai 2026 aktualisiert von: Ajit Chaudhari, Ohio State University
Ziel dieser Studie ist es, die potenzielle Rolle der Physiotherapie bei der Verbesserung der Ergebnisse nach der Reparatur ventraler Hernien zu bewerten.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Nachdem sie über die Studie und potenzielle Risiken informiert wurden, werden alle Patienten, die eine schriftliche Einverständniserklärung abgegeben haben, verschiedene Aktivitäten des täglichen Lebens beurteilen und mehrere Umfragen zu ihren präoperativen Fähigkeiten, ihrer Lebensqualität und ihren Schmerzen durchführen. Unmittelbar nach ihrem chirurgischen Eingriff werden die Patienten im Einzelblindverfahren (Untersucher) im Verhältnis 1:1 randomisiert einer überwachten Physiotherapie (8 Wochen, zweimal wöchentlich) oder standardmäßigen postoperativen Vorsichtsmaßnahmen zugeteilt. Bewertungen und Umfragen werden vom verblindeten Prüfer 30 Tage, 10 Wochen, 6 Monate und 1 Jahr nach der Operation wiederholt.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

138

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • Ohio State University Wexner Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien

  • Ab 18 Jahren
  • Diagnose einer ventralen Hernie
  • Geplant für eine elektive ventrale Hernienreparatur
  • Unabhängiger Funktionsstatus
  • Querhernienbreite von 2 cm oder mehr

Ausschlusskriterien

  • Zuvor diagnostizierte Bewegungs- oder Gleichgewichtsstörung
  • Verwendung von ambulanten Hilfsmitteln (Gehhilfe oder Gehstock)
  • Sie befinden sich derzeit nicht in einer Physiotherapie oder einer anderen qualifizierten Übungsmaßnahme unter Aufsicht eines medizinischen Rehabilitationsfachmanns und planen auch nicht, sich einer solchen zu unterziehen

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Standardmäßige postoperative Anweisungen
Den Teilnehmern der Kontrollgruppe wird bei der postoperativen Entlassung mitgeteilt, dass sie die postoperativen Anweisungen befolgen sollen.
Sonstiges: Postoperative Vorsichtsmaßnahmen
Dieser Eingriff umfasst standardmäßige postoperative Pflegeanweisungen, die typischerweise Patienten auf der ganzen Welt gegeben werden, die sich einer ventralen Hernienreparatur unterziehen. Dazu gehören die Einschränkung anstrengender körperlicher Aktivität und eine Hebebeschränkung von nicht mehr als 10 Pfund für 6 Wochen. Auch die Verwendung von Bindemitteln für 4–6 Wochen nach der Operation wird empfohlen.
Experimental: Beaufsichtigte Physiotherapie
Für die Teilnehmer der Physiotherapie-Gruppe sind ab zwei Wochen nach der Operation Besuche in der Physiotherapie-Klinik eingeplant und sie werden acht Wochen lang ungefähr zweimal pro Woche betreuten Physiotherapie-Behandlungen gemäß einer standardisierten, evidenzbasierten postoperativen Rehabilitation nach einer Bauchkernoperation unterzogen Programm.
Sonstiges: Beaufsichtigte Physiotherapie
Der zweimal pro Woche stattfindende 8-wöchige Kurs der überwachten Physiotherapie beginnt 2 Wochen nach der Operation. Es zielt auf die Funktion des Bauchkerns durch progressives Muskeltraining und -stärkung sowie patientenspezifische Haltungs- und Körpermechanikschulung ab.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in Five Times Sit-to-stand Time
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Hernia Related Quality of Life Survey From Baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Hernia Related Quality of Life Survey From Baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ohio State University

Mitarbeiter

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

19. April 2022

Primärer Abschluss (Tatsächlich)

18. Februar 2025

Studienabschluss (Tatsächlich)

23. Dezember 2025

Studienanmeldedaten

Zuerst eingereicht

3. November 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. November 2021

Zuerst gepostet (Tatsächlich)

2. Dezember 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2021H0336
  • R01DK131207 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Nur anonymisierte Daten werden mit anderen Forschern geteilt.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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