- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04321603
Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65 (ALTER)
People living with HIV are living longer as their disease is controlled with antiretroviral medications. Yet they are experiencing frailty more often and more than ten years earlier than those without HIV. In elderly persons without HIV, frailty is associated with decreased muscle strength and chronic inflammation. Less is known about what is driving early frailty in HIV or effective prevention measures for aging adults with HIV.
It may be that having HIV infection impairs energy production by mitochondria within the cells and contributes to the muscle weakness and inflammation accompanying frailty in people living with HIV . This study will examine the impact of six weeks of moderately paced walking on energy production in the cells, inflammation markers and frailty scores in people living with well-controlled HIV who are aged 50 to 65.
연구 개요
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults aged 50 to 65
- Documentation of HIV infection from Medical Provider
- Currently receiving antiretrovirals
- HIV viral load less than 50 iu/mL for at least six months
- CD4 count at least 350 cell/mm3 for the last six months
- Willing and able to walk at least 30 minutes 3 times weekly within 30 minutes of UMB
- Speaks English
Exclusion Criteria:
- Current smokers
- Weight less than 110 pounds
- Subjects taking long-term corticosteroids equivalent to 10mg/day or more, or immunomodulators
- Subjects with conditions known to affect inflammatory or mitochondrial function other than HIV, such as rheumatoid arthritis, gout, heart failure, chronic obstructive pulmonary disease, chronic kidney disease, diabetes, Parkinson's disease, Alzheimer's disease, active hepatitis, sleep apnea or autoimmune diseases.
- Current drug or alcohol use or dependence or unstable mental health conditions that, in the opinion of the investigator, would interfere with adherence to study requirements
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: People living with HIV
Subjects will act as own control between Visit one and Visit two, then will complete six weeks of walking, 30 minutes per walk, three times weekly between Visit Two and Visit Three.
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Moderately paced walking of approximately 100 steps/minute for 30 minutes three times weekly for six weeks.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mitochondrial Respiration PBMC and platelets
기간: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
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Change in mitochondrial respiratory capacity after a six-week walking intervention
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Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Inflammation IL-1β
기간: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months
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Change in IL-1β after a six-week walking intervention
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Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months
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Inflammation IL-6
기간: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
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Change in IL-6 after a six-week walking intervention
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Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
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Inflammation IL-10
기간: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
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Change in IL-10 after a six-week walking intervention
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Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
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Inflammation TNF-α
기간: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
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Change in TNF-α after a six-week walking intervention
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Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
|
Inflammation hsCRP
기간: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
Change in hsCRP after a six-week walking intervention
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Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Frailty Related Phenotype
기간: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
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Change in frailty phenotype score (0-5 with 3 to 5 indicating frailty) after a six-week walking intervention
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Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jennifer Klinedinst, PhD, Associate professor
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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. .