Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65 (ALTER)
3. august 2021 oppdatert av: Jennifer Klinedinst, University of Maryland, Baltimore
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.
Studieoversikt
Status
Tilbaketrukket
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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.
|
Moderately paced walking of approximately 100 steps/minute for 30 minutes three times weekly for six weeks.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mitochondrial Respiration PBMC and platelets
Tidsramme: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
Change in mitochondrial respiratory capacity after a six-week walking intervention
|
Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Inflammation IL-1β
Tidsramme: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months
|
Change in IL-1β after a six-week walking intervention
|
Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months
|
|
Inflammation IL-6
Tidsramme: 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
Tidsramme: 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
|
|
Inflammation TNF-α
Tidsramme: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
Change in TNF-α after a six-week walking intervention
|
Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
|
Inflammation hsCRP
Tidsramme: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
Change in hsCRP after a six-week walking intervention
|
Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Frailty Related Phenotype
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Jennifer Klinedinst, PhD, Associate professor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. mai 2020
Primær fullføring (Faktiske)
30. mai 2020
Studiet fullført (Faktiske)
30. mai 2020
Datoer for studieregistrering
Først innsendt
19. mars 2020
Først innsendt som oppfylte QC-kriteriene
24. mars 2020
Først lagt ut (Faktiske)
25. mars 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. august 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HP-00089501
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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Nei
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