Pilottikoe vatsan ytimen kuntouttamisesta tulosten parantamiseksi vatsatyrän korjauksen jälkeen (ABVENTURE-P)
torstai 7. toukokuuta 2026 päivittänyt: Ajit Chaudhari, Ohio State University
Tämän tutkimuksen tavoitteena on arvioida fysioterapian mahdollista roolia tulosten parantamisessa vatsatyrän korjauksen jälkeen.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Saatuaan tietoa tutkimuksesta ja mahdollisista riskeistä kaikki kirjallisen tietoon perustuvan suostumuksen antavat potilaat suorittavat arviointeja useista päivittäisistä toiminnoista ja suorittavat useita tutkimuksia, joissa selvitetään heidän leikkausta edeltäviä kykyjään, elämänlaatuaan ja kipujaan.
Välittömästi kirurgisen toimenpiteen jälkeen potilaat satunnaistetaan yksisokkomenetelmällä (tutkija) suhteessa 1:1 valvottuun fysioterapiaan (8 viikkoa, kahdesti viikossa) tai tavanomaisiin leikkauksen jälkeisiin varotoimenpiteisiin.
Sokkoutunut tutkija toistaa arvioinnit ja tutkimukset 30 päivän, 10 viikon, 6 kuukauden ja 1 vuoden kuluttua leikkauksesta.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
138
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
Ohio
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Columbus, Ohio, Yhdysvallat, 43210
- Ohio State University Wexner Medical Center
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Sisällyttämiskriteerit
- Ikäraja 18+
- Vatsatyrän diagnoosi
- Suunniteltu valinnaiseen vatsatyrän korjaukseen
- Itsenäinen toimintatila
- Poikittainen tyrän leveys 2 cm tai suurempi
Poissulkemiskriteerit
- Aiemmin diagnosoitu liike- tai tasapainohäiriö
- Ambulatiivinen apuväline (kävelijä tai keppi)
- Et tällä hetkellä käy tai suunnittele fysioterapiaa tai muuta taitavaa harjoittelua lääketieteellisen kuntoutuksen ammattilaisen valvonnassa
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Active Comparator: Normaalit leikkauksen jälkeiset ohjeet
Kontrolliryhmän osallistujille kerrotaan leikkauksen jälkeisen kotiutuksen yhteydessä, että heidän tulee noudattaa leikkauksen jälkeisiä ohjeita.
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Tämä interventio sisältää tavanomaiset leikkauksen jälkeiset ohjeet, jotka tyypillisesti annetaan potilaille, joille tehdään vatsatyräkorjaus kaikkialla maailmassa.
Näitä ovat rasittavan fyysisen toiminnan rajoittaminen ja enintään 10 kilon nostorajoitus 6 viikon ajan.
Sideaineen käyttöä suositellaan myös 4-6 viikon ajan leikkauksen jälkeen.
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Kokeellinen: Valvottu fysioterapia
Fysioterapiaryhmän osallistujat saavat käynnit fysioterapiaklinikalla kahden viikon kuluttua leikkauksesta ja he käyvät läpi valvottuja fysioterapiahoitoja noin kahdesti viikossa kahdeksan viikon ajan standardoidun näyttöön perustuvan leikkauksen jälkeisen vatsaleikkauksen jälkeisen kuntoutuksen mukaisesti. ohjelmoida.
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Kahdesti viikossa 8 viikon ohjattu fysioterapiakurssi alkaa 2 viikkoa leikkauksen jälkeen.
Se kohdistuu vatsan ydintoimintoihin progressiivisen lihasten uudelleenkoulutuksen ja vahvistamisen sekä potilaskohtaisen asennon ja kehon mekaniikkakoulutuksen kautta.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change From Baseline in Five Times Sit-to-stand Time
Aikaikkuna: 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
Aikaikkuna: 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
|
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Change From Baseline in Quiet Unstable Sitting Test
Aikaikkuna: 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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Hernia Related Quality of Life Survey From Baseline
Aikaikkuna: 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
|
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Change in Timed Up-And-Go Time From Baseline
Aikaikkuna: 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
Aikaikkuna: 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
|
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Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Aikaikkuna: baseline before surgery, 10 weeks after surgery
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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.
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baseline before surgery, 10 weeks after surgery
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Number of Participants With Hernia Recurrence Using the Hernia Recurrence Inventory
Aikaikkuna: 1 year after surgery
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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
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Change in Hernia Related Quality of Life Survey From Baseline
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
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Change From Baseline in Five Times Sit-to-stand Time
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Hernia Related Quality of Life Survey From Baseline
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
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Opintojen valmistuminen (Todellinen)
Tiistai 23. joulukuuta 2025
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 3. marraskuuta 2021
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Perjantai 19. marraskuuta 2021
Ensimmäinen Lähetetty (Todellinen)
Torstai 2. joulukuuta 2021
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 3. kesäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 7. toukokuuta 2026
Viimeksi vahvistettu
Perjantai 1. toukokuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2021H0336
- R01DK131207 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
IPD-suunnitelman kuvaus
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Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .