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Pilotforsøg med abdominal core-rehabilitering for at forbedre resultaterne efter reparation af ventral brok (ABVENTURE-P)

7. maj 2026 opdateret af: Ajit Chaudhari, Ohio State University
Denne undersøgelse har til formål at evaluere den potentielle rolle af fysioterapi i at forbedre resultaterne efter reparation af ventral brok.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Efter at være blevet informeret om undersøgelsen og potentielle risici, vil alle patienter, der giver skriftligt informeret samtykke, udføre vurderinger af flere daglige aktiviteter og gennemføre adskillige undersøgelser, der beskriver deres præ-kirurgiske evner, livskvalitet og smerte. Umiddelbart efter deres kirurgiske procedure vil patienter blive randomiseret på en enkelt-blind måde (investigator) i et forhold på 1:1 til superviseret fysioterapi (8 uger, to gange om ugen) eller standard post-kirurgiske forholdsregler. Vurderinger og undersøgelser vil blive gentaget af den blindede investigator 30 dage, 10 uger, 6 måneder og 1 år efter operationen.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

138

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University Wexner Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier

  • Alder 18+
  • Diagnose af ventral brok
  • Planlagt til elektiv ventral brok reparation
  • Uafhængig funktionsstatus
  • Tværbrok bredde på 2 cm eller mere

Eksklusionskriterier

  • Tidligere diagnosticeret bevægelses- eller balanceforstyrrelse
  • Brug af ambulant hjælpemiddel (rollator eller stok)
  • Ikke i øjeblikket gennemgår eller planlægger at gennemgå fysioterapi eller anden kvalificeret træningsintervention overvåget af en medicinsk rehabiliteringsprofessionel

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard postoperative instruktioner
Deltagerne i kontrolgruppen vil ved postoperativ udskrivning få at vide, at de skal følge postoperative instruktioner.
Andet: Postoperative forholdsregler
Denne intervention omfatter postoperative standardinstruktioner, der typisk gives til patienter, der gennemgår reparation af ventral brok over hele verden. Disse omfatter begrænsning af anstrengende fysisk aktivitet og en løftebegrænsning på ikke mere end 10 pund i 6 uger. Brug af bindemiddel anbefales også i 4-6 uger efter operationen.
Eksperimentel: Superviseret fysioterapi
Deltagerne i fysioterapigruppen vil blive planlagt til besøg på fysioterapiklinikken begyndende to uger efter operationen og vil gennemgå superviserede fysioterapibehandlinger cirka to gange om ugen i otte uger i henhold til en standardiseret evidensbaseret postoperativ abdominal kernekirurgisk rehabilitering program.
Andet: Superviseret fysioterapi
To gange om ugen 8-ugers forløb med superviseret fysioterapi begynder 2 uger efter operationen. Den retter sig mod abdominal kernefunktion gennem progressiv muskelgenoptræning og -styrkelse og patientspecifik kropsholdnings- og kropsmekanikuddannelse.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Five Times Sit-to-stand Time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Hernia Related Quality of Life Survey From Baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Hernia Related Quality of Life Survey From Baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ohio State University

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. april 2022

Primær færdiggørelse (Faktiske)

18. februar 2025

Studieafslutning (Faktiske)

23. december 2025

Datoer for studieregistrering

Først indsendt

3. november 2021

Først indsendt, der opfyldte QC-kriterier

19. november 2021

Først opslået (Faktiske)

2. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021H0336
  • R01DK131207 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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