- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05097885
전신 진동의 건강상의 이점 (VIBE-Rx)
아급성(12주) 전신 진동 훈련의 건강상의 이점에 대한 파일럿 조사
The overall goals of this pilot investigation are to determine 1) the feasibility of conducting home based WBV studies, and 2) to determine if sub-acute home based WBV can improve a) exercise capacity, b) conduit- and micro- vascular function, and c) skeletal muscle function.
연구 개요
상세 설명
Cardiovascular disease (CVD) is the leading cause of death in the world and many comorbid conditions (i.e. diabetes, obesity) can affect overall CVD risk. There is increasing interest into the role that skeletal muscle health plays in mediating CVD risk, particularly in metabolic disease states (ie. obesity and diabetes). Whole body vibration (WBV) has emerged as an exercise mimetic that may be more tolerable than traditional modes of exercise, such as treadmill walking/running or cycling. Similar to traditional exercise modalities, WBV can elicit beneficial metabolic effects. In fact, a single bout of WBV increases circulating concentrations of IL-6, which correspond with the normalization of glucose and insulin in obese individuals. The proposed pilot investigation will provide the foundation to begin understanding the molecular and physiological mechanisms of how sub-acute WBV can improve overall CVD risk. We hypothesize that home based WBV will decrease CVD risk by improving skeletal muscle and vascular function via a decrease in systemic inflammation.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Georgia
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Augusta, Georgia, 미국, 30912
- Augusta University/Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and women (> 18 yrs old)
- All races
Exclusion Criteria:
- <18 years old
- Clinical diagnosis of hepatic, cardiovascular, or renal disease
- Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
- Pregnancy
- Direct vasoactive medications (i.e. nitrates)
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: 아급성 (12주) 전신 훈련
|
Participants will be given a personal vibration plate to take home with them for training which will last for 12 weeks. For the first four weeks, participants will be asked to complete 10 minutes of WBV per day (1 minute on and up to 1 minute of rest), at least 3-4 days per week. At least 24 hours will be recommended in between sessions during weeks 1-4. Beginning at week 5, participants will be asked to increase WBV time to up to 14 minutes and/or reduce the duration of rest. Beginning at week 9, participants will be asked to increase WBV time to up to 20 minutes and/or reduce the duration of rest. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in VO2 Peak
기간: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
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change from baseline relative (mL/kg/min) peak oxygen consumption (VO2) during maximal exercise test at 12 weeks |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
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|
Change in Flow-Mediated Dilation (FMD)
기간: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
change from baseline brachial artery flow mediated dilation at 12 weeks. |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
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|
Change in Skeletal Muscle Mitochondrial Function
기간: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
change from baseline skeletal muscle mitochondrial function at 12 weeks. Measured using Near Infrared Spectroscopy (NIRS). Values are an index of phosphocreatine recovery expressed as a rate constant (min-1) |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
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|
Change in Pulse Wave Velocity (PWV)
기간: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
Change from baseline PWV at 12 weeks. Measured by Shygmocor Xcel in m/s. |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
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|
Change in Post Occlusive Reactive Hyperemia (PORH)
기간: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
Change from baseline PORH at 12 weeks. Measured by Laser Speckle Contrast Imager (Moor FLPI). |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
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|
Change in IL-6
기간: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
change from baseline concentrations of Interleukin 6 (IL-6) obtained via blood draw at 12 weeks. |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
기타 연구 ID 번호
- 1818010
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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