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

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 Overview

• Status: Withdrawn
• Conditions: Hiv; Frailty Syndrome
• Intervention / Treatment: Behavioral: Walking

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Walking; Moderately paced walking of approximately 100 steps/minute for 30 minutes three times weekly for six weeks.; Other Names: physical activity

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty Related Phenotype	Change in frailty phenotype score (0-5 with 3 to 5 indicating frailty) after a six-week walking intervention	Day 0, Week 6, Week 12 with intervention between weeks 6 and 12

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Jennifer Klinedinst, PhD, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2020
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; inflammation; mitochondrial respiration
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: HP-00089501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No