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

NCT04321603 | Withdrawn

• 1 other identifier: HP-00089501
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

physical activity; mitochondrial respiration; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Inflammation IL-1β

  Day 0, Week 6, Week 12 with intervention between weeks 6 and 12 months

• Inflammation IL-6

  Day 0, Week 6, Week 12 with intervention between weeks 6 and 12

• Inflammation IL-10

  Day 0, Week 6, Week 12 with intervention between weeks 6 and 12

• Inflammation TNF-α

  Day 0, Week 6, Week 12 with intervention between weeks 6 and 12

• Inflammation hsCRP

  Day 0, Week 6, Week 12 with intervention between weeks 6 and 12

Other Outcomes (1)

• Frailty Related Phenotype

  Day 0, Week 6, Week 12 with intervention between weeks 6 and 12

Study Arms (1)

People living with HIV

OTHER

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

Interventions

Walking BEHAVIORAL

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

Also known as: physical activity

People living with HIV

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Frailty; Motor Activity; Inflammation

Interventions

Walking; Exercise

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Motor Activity

Study Officials

• Jennifer Klinedinst, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 25, 2020
• Study Start: May 30, 2020
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share