search
Back to results

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

Primary Purpose

Hiv, Frailty Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Walking
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hiv focused on measuring physical activity, mitochondrial respiration, inflammation

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    People living with HIV

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Mitochondrial Respiration PBMC and platelets
    Change in mitochondrial respiratory capacity after a six-week walking intervention

    Secondary Outcome Measures

    Inflammation IL-1β
    Change in IL-1β after a six-week walking intervention
    Inflammation IL-6
    Change in IL-6 after a six-week walking intervention
    Inflammation IL-10
    Change in IL-10 after a six-week walking intervention
    Inflammation TNF-α
    Change in TNF-α after a six-week walking intervention
    Inflammation hsCRP
    Change in hsCRP after a six-week walking intervention

    Full Information

    First Posted
    March 19, 2020
    Last Updated
    August 3, 2021
    Sponsor
    University of Maryland, Baltimore
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04321603
    Brief Title
    Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65
    Acronym
    ALTER
    Official Title
    Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    COVID-19 prevented us from doing this human subjects study
    Study Start Date
    May 30, 2020 (Actual)
    Primary Completion Date
    May 30, 2020 (Actual)
    Study Completion Date
    May 30, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Maryland, Baltimore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hiv, Frailty Syndrome
    Keywords
    physical activity, mitochondrial respiration, inflammation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This within-subjects design will allow each subject to be utilized as their own control pre-intervention. With expectation of great inter-person variability of oxygen consumption results, this design will incorporate less error than separately recruited controls and decrease the needed sample size.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    People living with HIV
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Walking
    Other Intervention Name(s)
    physical activity
    Intervention Description
    Moderately paced walking of approximately 100 steps/minute for 30 minutes three times weekly for six weeks.
    Primary Outcome Measure Information:
    Title
    Mitochondrial Respiration PBMC and platelets
    Description
    Change in mitochondrial respiratory capacity after a six-week walking intervention
    Time Frame
    Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
    Secondary Outcome Measure Information:
    Title
    Inflammation IL-1β
    Description
    Change in IL-1β after a six-week walking intervention
    Time Frame
    Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months
    Title
    Inflammation IL-6
    Description
    Change in IL-6 after a six-week walking intervention
    Time Frame
    Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
    Title
    Inflammation IL-10
    Description
    Change in IL-10 after a six-week walking intervention
    Time Frame
    Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
    Title
    Inflammation TNF-α
    Description
    Change in TNF-α after a six-week walking intervention
    Time Frame
    Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
    Title
    Inflammation hsCRP
    Description
    Change in hsCRP after a six-week walking intervention
    Time Frame
    Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
    Other Pre-specified Outcome Measures:
    Title
    Frailty Related Phenotype
    Description
    Change in frailty phenotype score (0-5 with 3 to 5 indicating frailty) after a six-week walking intervention
    Time Frame
    Day 0, Week 6, Week 12 with intervention between weeks 6 and 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jennifer Klinedinst, PhD
    Organizational Affiliation
    Associate Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs