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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hiv, Frailty Syndrome

Intervention / Treatment
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* Behavioral: Walking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: People living with HIV<br>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. | Behavioral: Walking<br>* Moderately paced walking of approximately 100 steps/minute for 30 minutes three times weekly for six weeks.<br>* Other names: physical activity;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation IL-1β | 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 | 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 | 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 | 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 | Change in hsCRP after a six-week walking intervention | Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, mitochondrial respiration, inflammation