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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04321603
Acronym
ALTER
Enrollment
0
Registered
2020-03-25
Start date
2020-05-30
Completion date
2020-05-30
Last updated
2021-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty Syndrome, Hiv

Keywords

physical activity, mitochondrial respiration, inflammation

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.

Interventions

BEHAVIORALWalking

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

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mitochondrial Respiration PBMC and plateletsDay 0, Week 6, Week 12 with intervention between weeks 6 and 12Change in mitochondrial respiratory capacity after a six-week walking intervention

Secondary

MeasureTime frameDescription
Inflammation hsCRPDay 0, Week 6, Week 12 with intervention between weeks 6 and 12Change in hsCRP after a six-week walking intervention
Inflammation IL-1βDay 0, Week 6, Week 12 with intervention between weeks 6 and 12 monthsChange in IL-1β after a six-week walking intervention
Inflammation IL-10Day 0, Week 6, Week 12 with intervention between weeks 6 and 12Change in IL-10 after a six-week walking intervention
Inflammation TNF-αDay 0, Week 6, Week 12 with intervention between weeks 6 and 12Change in TNF-α after a six-week walking intervention
Inflammation IL-6Day 0, Week 6, Week 12 with intervention between weeks 6 and 12Change in IL-6 after a six-week walking intervention

Other

MeasureTime frameDescription
Frailty Related PhenotypeDay 0, Week 6, Week 12 with intervention between weeks 6 and 12Change in frailty phenotype score (0-5 with 3 to 5 indicating frailty) after a six-week walking intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026