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.
調査の概要
研究の種類
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mitochondrial Respiration PBMC and platelets
時間枠：Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Inflammation IL-1β
時間枠：Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months
|
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
時間枠：Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
Change in IL-6 after a six-week walking intervention
|
Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
|
Inflammation IL-10
時間枠：Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
Change in IL-10 after a six-week walking intervention
|
Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
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Inflammation TNF-α
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frailty Related Phenotype
時間枠：Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
Change in frailty phenotype score (0-5 with 3 to 5 indicating frailty) after a six-week walking intervention
|
Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
協力者と研究者
捜査官
- 主任研究者：Jennifer Klinedinst, PhD、Associate professor
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。