- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03864835
NASH-FITTER: Nonalcoholic Steatohepatitis Fitness Intervention Treatment Targeting Endothelial Dysfunction Reversal (NASH-FITTER)
This research is being done to find out if aerobic exercise is beneficial in reversing scarring. Physical activity has been shown to increase fitness in healthy individuals as well as in those with NASH. This research will allow for better understanding the effects of physical activity on fitness and endothelial function in patients with NASH with the goal of reversing scarring.
Approximately 12 people will take part in this research study at Penn State (PSU) Milton S. Hershey Medical Center (HMC), Penn State Physical Medicine & Research (PM&R) Laboratories housed at the Hershey Center for Applied Research (HCAR) and the Penn State University Fitness Center (UFC).
연구 개요
상세 설명
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
•Enrollment and completion of IRB study # 00011797
Exclusion Criteria
- Inability to provide informed consent
- Institutionalized/prisoner
- Non-English-speaking patients due to unavailability of translators for all visits/sessions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Moderate intensity aerobic exercise
All subjects will undergo DXA and CRF measurement (relative VO2max) under the supervision of an American College of Sports Medicine (ACSM)-certified fitness professional and study physician at the Penn State PM&R Research Laboratories.
Subjects selected for the interventional pilot trial will receive a FitBit Charge2 HR and be instructed on how to use a FitBit Hear Rate monitor, Fitbit application, Fitbit website, and Fitabase (secure data management platform utilized by >400 clinical trials).
Participants will record their daily food and beverage intake through the Fitbit app.
Individualized feedback will be provided by a registered dietician (RD).
Subjects that meet requirements for the exercise arm (12 total) will be required to exercise 30 minutes, five days per week at a moderate intensity (HR target corresponding to 45-55% of their relative VO2max).
Each session will be supervised in-person at the Penn State University Fitness Center with an ACSM certified exercise physiologist.
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Subjects that meet requirements for the exercise arm (12 total) will be required to exercise 30 minutes, five days per week at a moderate intensity (HR target corresponding to 45-55% of their relative VO2max).
Each session will be supervised in-person at the Penn State University Fitness Center with an ACSM certified exercise physiologist.
This is feasible as Zhang et al.(87) found 66 out of 70 subjects (95%) completed the twelve-month supervised in-person moderate-intensity exercise protocol five-days a week.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
hepatic fibrosis stage using METAVIR score
기간: 12 months
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The primary endpoint of this study is change in hepatic fibrosis stage.
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12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
fibrosis change and gains in cardiorespiratory fitness
기간: 12 months
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correlation between fibrosis change and gains in CRF
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12 months
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flow mediated dilation
기간: 12 months
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correlation between fibrosis change and improvements in FMD
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12 months
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NAFLD Activity Score (NAS)
기간: 12 months
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The diagnosis of nonalcoholic steatohepatitis (NASH) is defined by the presence and pattern of specific histological abnormalities on liver biopsy.
A separate system of scoring the features of nonalcoholic fatty liver disease (NA) called the NAFLD Activity Score (NAS) was developed as a tool to measure changes in NAFLD.
The grading or NAFLD activity score (NAS) encompasses steatosis, lobular inflammation and ballooning.
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12 months
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intra-hepatic fat content
기간: 12 months
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changes in intra-hepatic fat content
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12 months
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health related quality of life (HRQOL)
기간: 12 months
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PROMIS is a computer adaptive test (CATs) used to assess health related quality of life.
The survey contains profiles that measure multiple concepts through a fixed collection of short forms.
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12 months
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Body composition
기간: 12 months
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body composition change
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12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jonathan G Stine, MD, Milton S. Hershey Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
NASH - 비알코올성 지방간염에 대한 임상 시험
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Galmed Pharmaceuticals LtdQuotient Sciences완전한
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Enanta Pharmaceuticals, Inc완전한
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Milton S. Hershey Medical Center아직 모집하지 않음간 질환 | NASH - 비알코올성 지방간염 | NASH
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Milton S. Hershey Medical Center모병
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Assistance Publique - Hôpitaux de Paris아직 모집하지 않음섬유증 | 경화증 | NAFLD | NASH - 비알코올성 지방간염 | NASH
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