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

NCT ID: NCT04321603

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-30
• Study Completion Date: 2020-05-30

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.

Conditions

Hiv; Frailty Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Walking

Intervention Type: BEHAVIORAL

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

Interventions

Walking

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

Intervention Type: BEHAVIORAL

Other Intervention Names

physical activity

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Klinedinst

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Klinedinst, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Other Identifiers

HP-00089501

Identifier Type: -

Identifier Source: org_study_id