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Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65 (ALTER)

3. august 2021 opdateret af: 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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Adfærdsmæssigt: Walking
Moderately paced walking of approximately 100 steps/minute for 30 minutes three times weekly for six weeks.
Andre navne:
  • fysisk aktivitet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Maryland, Baltimore

Efterforskere

  • Ledende efterforsker: Jennifer Klinedinst, PhD, Associate Professor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. maj 2020

Primær færdiggørelse (Faktiske)

30. maj 2020

Studieafslutning (Faktiske)

30. maj 2020

Datoer for studieregistrering

Først indsendt

19. marts 2020

Først indsendt, der opfyldte QC-kriterier

24. marts 2020

Først opslået (Faktiske)

25. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HP-00089501

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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