- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05142618
복부 탈장 수리 후 결과를 개선하기 위한 복부 코어 재활의 파일럿 시험 (ABVENTURE-P)
2026년 5월 7일 업데이트: Ajit Chaudhari, Ohio State University
이 연구는 복부 탈장 수리 후 결과를 개선하는 데 있어 물리 치료의 잠재적인 역할을 평가하는 것을 목표로 합니다.
연구 개요
상세 설명
연구 및 잠재적 위험에 대한 정보를 받은 후 서면 동의서를 제공한 모든 환자는 일상 생활의 여러 활동에 대한 평가를 수행하고 수술 전 능력, 삶의 질 및 통증을 자세히 설명하는 여러 설문 조사를 완료합니다.
수술 직후 환자는 감독 물리 치료(8주, 주 2회) 또는 표준 수술 후 예방 조치에 대해 1:1 비율로 단일 맹검 방식(조사자)으로 무작위 배정됩니다.
평가 및 설문 조사는 수술 후 30일, 10주, 6개월 및 1년에 맹검 연구자에 의해 반복됩니다.
연구 유형
중재적
등록 (실제)
138
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ohio
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Columbus, Ohio, 미국, 43210
- Ohio State University Wexner Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준
- 18세 이상
- 복부 탈장 진단
- 선택적 복부 탈장 수리 예정
- 독립적인 기능 상태
- 가로 탈장 너비 2cm 이상
제외 기준
- 이전에 진단된 운동 또는 균형 장애
- 보행 보조 장치(보행기 또는 지팡이) 사용
- 의료 재활 전문가가 감독하는 물리 치료 또는 기타 숙련된 운동 개입을 현재 진행 중이거나 받을 계획이 없음
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 표준 수술 후 지침
통제 그룹의 참가자는 수술 후 퇴원 시 수술 후 지침을 따라야 한다는 말을 듣게 됩니다.
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이 중재에는 전 세계적으로 복부 탈장 치료를 받는 환자에게 일반적으로 제공되는 수술 후 치료 지침의 표준이 포함됩니다.
여기에는 격렬한 신체 활동 제한과 6주 동안 10파운드 이하의 리프팅 제한이 포함됩니다.
수술 후 4-6주 동안 바인더 사용도 권장됩니다.
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실험적: 감독 물리 치료
물리 치료 그룹의 참가자는 수술 후 2주부터 물리 치료 클리닉을 방문하고 표준화된 근거 기반 수술 후 복부 코어 수술 재활에 따라 8주 동안 약 주당 2회 물리 치료 치료를 받게 됩니다. 프로그램.
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주 2회 8주 감독 물리 치료 과정은 수술 2주 후에 시작됩니다.
점진적 근육 재훈련 및 강화, 환자 맞춤형 자세 및 신체 역학 교육을 통해 복부 코어 기능을 목표로 합니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in Five Times Sit-to-stand Time
기간: 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
|
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Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
기간: 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.
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Baseline before surgery, 10 weeks after surgery
|
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Change From Baseline in Quiet Unstable Sitting Test
기간: 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.
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Baseline before surgery, 10 weeks after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Hernia Related Quality of Life Survey From Baseline
기간: 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.
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baseline before surgery, 10 weeks after surgery
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Change in Timed Up-And-Go Time From Baseline
기간: baseline before surgery, 10 weeks after surgery
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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
|
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Change From Baseline in International Physical Activity Questionnaire - Short Form
기간: 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.
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baseline before surgery, 10 weeks after surgery
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Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
기간: 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
기간: 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
기간: 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
|
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Change in Timed Up-And-Go Time From Baseline
기간: 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
|
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Change From Baseline in International Physical Activity Questionnaire - Long Form
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Hernia Related Quality of Life Survey From Baseline
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 4월 19일
기본 완료 (실제)
2025년 2월 18일
연구 완료 (실제)
2025년 12월 23일
연구 등록 날짜
최초 제출
2021년 11월 3일
QC 기준을 충족하는 최초 제출
2021년 11월 19일
처음 게시됨 (실제)
2021년 12월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 7일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2021H0336
- R01DK131207 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
식별되지 않은 데이터만 다른 연구자와 공유됩니다.
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .