Clinical trial NCT04321603: Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65
Official title: Altering Mechanisms of Frailty in Persons Living With HIV Aged 50 to 65
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hiv
Frailty Syndrome
Keywords: physical activity
mitochondrial respiration
inflammation
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Mitochondrial Respiration PBMC and platelets
timeFrame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Secondary outcomes:
measure: Inflammation IL-1β
timeFrame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months
measure: Inflammation IL-6
timeFrame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
measure: Inflammation IL-10
timeFrame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
measure: Inflammation TNF-α
timeFrame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
measure: Inflammation hsCRP
timeFrame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Other outcomes:
measure: Frailty Related Phenotype
timeFrame: Day 0, Week 6, Week 12 with intervention between weeks 6 and 12
Locations:
Study officials:
affiliation: Associate Professor
name: Jennifer Klinedinst, PhD
role: PRINCIPAL_INVESTIGATOR
References: