Pilotní zkouška rehabilitace břišního jádra ke zlepšení výsledků po opravě ventrální kýly (ABVENTURE-P)
7. května 2026 aktualizováno: Ajit Chaudhari, Ohio State University
Tato studie si klade za cíl zhodnotit potenciální roli fyzikální terapie při zlepšování výsledků po úpravě ventrální kýly.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
Poté, co byli informováni o studii a potenciálních rizicích, všichni pacienti, kteří dají písemný informovaný souhlas, provedou hodnocení několika činností každodenního života a provedou několik průzkumů podrobně popisujících jejich předoperační schopnosti, kvalitu života a bolest.
Bezprostředně po chirurgickém výkonu budou pacienti randomizováni jednoduše zaslepeným způsobem (zkoušející) v poměru 1:1 k fyzioterapii pod dohledem (8 týdnů, dvakrát týdně) nebo standardním pooperačním opatřením.
Hodnocení a průzkumy budou zaslepeným zkoušejícím opakovat 30 dní, 10 týdnů, 6 měsíců a 1 rok po operaci.
Typ studie
Intervenční
Zápis (Aktuální)
138
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ohio
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Columbus, Ohio, Spojené státy, 43210
- Ohio State University Wexner Medical Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria pro zařazení
- Věk 18+
- Diagnóza ventrální kýly
- Plánováno na elektivní opravu ventrální kýly
- Nezávislý funkční stav
- Šířka příčné kýly 2 cm nebo větší
Kritéria vyloučení
- Dříve diagnostikovaná porucha pohybu nebo rovnováhy
- Použití ambulantního pomocného zařízení (chodítko nebo hůl)
- V současné době nepodstupujete ani neplánujete podstoupit fyzikální terapii nebo jinou kvalifikovanou cvičební intervenci pod dohledem odborníka na lékařskou rehabilitaci
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Standardní pooperační pokyny
Účastníkům kontrolní skupiny bude při pooperačním propuštění sděleno, že by se měli řídit pooperačními pokyny.
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Tato intervence zahrnuje standardní pooperační pokyny, které se obvykle poskytují pacientům podstupujícím opravu ventrální kýly po celém světě.
Patří mezi ně omezení namáhavé fyzické aktivity a omezení zvedání ne více než 10 liber po dobu 6 týdnů.
Použití pojiva se také doporučuje po dobu 4-6 týdnů po operaci.
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Experimentální: Fyzikální terapie pod dohledem
Účastníci ve skupině fyzikální terapie budou naplánováni na návštěvy na klinice fyzikální terapie začínající dva týdny po operaci a budou podstupovat fyzioterapeutické ošetření pod dohledem přibližně dvakrát týdně po dobu osmi týdnů podle standardizované pooperační abdominální jádrové chirurgické rehabilitace založené na důkazech. program.
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Dvakrát týdně 8týdenní kúra fyzioterapie pod dohledem začíná 2 týdny po operaci.
Zaměřuje se na funkci břišního jádra prostřednictvím progresivního přeškolování a posilování svalů a vzdělávání v oblasti držení těla a tělesné mechaniky specifické pro pacienta.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in Five Times Sit-to-stand Time
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Hernia Related Quality of Life Survey From Baseline
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Number of Participants With Hernia Recurrence Using the Hernia Recurrence Inventory
Časové okno: 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.
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1 year after surgery
|
|
Change in Hernia Related Quality of Life Survey From Baseline
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Hernia Related Quality of Life Survey From Baseline
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
19. dubna 2022
Primární dokončení (Aktuální)
18. února 2025
Dokončení studie (Aktuální)
23. prosince 2025
Termíny zápisu do studia
První předloženo
3. listopadu 2021
První předloženo, které splnilo kritéria kontroly kvality
19. listopadu 2021
První zveřejněno (Aktuální)
2. prosince 2021
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
3. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
7. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2021H0336
- R01DK131207 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
S ostatními výzkumníky budou sdílena pouze neidentifikovaná data.
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Ne
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Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .