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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2020

Interventions

  • Behavioral: Walking
    • Moderately paced walking of approximately 100 steps/minute for 30 minutes three times weekly for six weeks.

Arms, Groups and Cohorts

  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Mitochondrial Respiration PBMC and platelets
    • Time Frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
    • Change in mitochondrial respiratory capacity after a six-week walking intervention

Secondary Measures

  • Inflammation IL-1β
    • Time Frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months
    • Change in IL-1β after a six-week walking intervention
  • Inflammation IL-6
    • Time Frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
    • Change in IL-6 after a six-week walking intervention
  • Inflammation IL-10
    • Time Frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
    • Change in IL-10 after a six-week walking intervention
  • Inflammation TNF-α
    • Time Frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
    • Change in TNF-α after a six-week walking intervention
  • Inflammation hsCRP
    • Time Frame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
    • Change in hsCRP after a six-week walking intervention

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Maryland, Baltimore
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jennifer Klinedinst, Associate Professor – University of Maryland, Baltimore
  • Overall Official(s)
    • Jennifer Klinedinst, PhD, Principal Investigator, Associate Professor
  • Overall Contact(s)
    • Amy Nelson, MS BSN, 410-706-0100, a.nelson@umaryland.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.