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

Not Applicable

Withdrawn

• Conditions: Frailty Syndrome; Hiv
• Interventions: Behavioral: Walking

• Registration Number: NCT04321603
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-25
• Study Start: 2020-05-30
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
People living with HIV	Walking	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.

Primary Outcome Measures

Name	Time	Method
Mitochondrial Respiration PBMC and platelets	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 Outcome Measures

Name	Time	Method
Inflammation IL-1β	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	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	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	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	Day 0, Week 6, Week 12 with intervention between weeks 6 and 12	Change in hsCRP after a six-week walking intervention