Exercise Training to Improve Brain Health in Older HIV+ Individuals

NCT02663934 | Terminated Results DMC

• 1 other identifier: 201508002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Management and treatment of older persons living with HIV (PLWH) (≥ 40 years old) is becoming increasingly more complex as a majority is greater than 40 years old. This proposal will conduct a prospective controlled intervention trial to assess the quantitative and qualitative effects of a monitored aerobic/resistance exercise (EXS) program compared to a social-interaction stretching (SIS) program on brain health (neuropsychological performance testing and neuroimaging measurements) in older PLWH. These results could influence public health policy by encouraging PLWH to adopt a more physically active lifestyle and stimulate the development of effective EXS programs for older PLWH.

Conditions

HIV

Keywords

HIV, AIDS, Cognition, Memory, Exercise, Stretching

Outcome Measures

Primary Outcomes (3)

• Change in Global Cognition From Baseline to Follow up, in Exercise Group vs. Stretching Group

  This measure examines the global z-score which is an average of all the individual cognitive test z scores. We looked at changes in global Z-scores from baseline to follow-up (6 months). A Z-score of 0 represents the population mean. Z-scores are considered to be better when they are above the mean and represent a better outcome.

  6 months

• Changes in Brain Structural/Functional Measures in Older PLWH

  The Investigators will assess if an EXS program improves brain structure and function more than a SIS program in older sedentary PLWH. Changes in brain volumetrics (total cortex volume) at baseline (BL) and 26 weeks will be compared between EXS and SIS groups.

  26 weeks

• Change in Level of Daily Activity

  Investigators will examine the amount of change in daily activity based on 7-day actigraphy at baseline and then again at follow-up (26 weeks later). Daily activity is measured using an actigraph that participants wear on their wrist and it measures the amount of time spent in sedentary, slightly active, moderately active, vigorously active or very vigorously active categories.

  6 Months

Study Arms (2)

Exercise (EXS)

EXPERIMENTAL

All EXS sessions will be at an exercise facility at the WUSTL medical campus. Sessions will be offered weekdays. Each session will start with range of motion exercises. Participants will follow an individualized exercise training prescription based on baseline cardiovascular testing. Individual aerobic exercise intensity is based on % of maximum heart rate achieved during the baseline cardiorespiratory fitness test. The target exercise HR will start at 50% and progress to 85% HR reserve. During aerobic exercise, a battery-operated HR monitor will monitor HR. Exercise intensity \& duration will be increased as the participant acclimates to the exercise prescription. Adaptation is determined when a given exercise intensity yields a lower HR than prior sessions conducted at the same intensity.

Behavioral: Exercise

Social Interaction Stretching (SIS)

ACTIVE COMPARATOR

This group will serve as a control group against which to gauge the effects of aerobic and resistance training on cognitive function. Participants in this group will follow the same schedule and format as the EXS group. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program. These SIS participants will receive instructions on stretching, range of motion, limbering, and toning; but the intensity will be far less than that achieved in the EXS classes. Activities will focus on flexibility enhancement. As the participant's level of flexibility increases, stretches with increasing levels of difficulty will be incorporated into the program.

Behavioral: Stretching and Social Interaction

Interventions

Exercise BEHAVIORAL

The resistance exercise training component will follow aerobic exercise and will consist of 4 upper and 3 lower body routines. A combination of guided-motion machines and free weights will be used. Voluntary maximum strength will be measured during the first 4 sessions on each exercise station. The program will initially consist of 1-2 sets of each exercise while lifting a weight that causes muscle fatigue after 8-10 repetitions. The trainer will monitor each participant's exercise response, and when the participant can comfortably lift the weight for 12 repetitions on any exercise, the weight will be increased to cause the muscle group to fatigue after 8 repetitions. This progressive 8-12 repetition cycle is repeated for each exercise over 26 weeks.

Exercise (EXS)

Stretching and Social Interaction BEHAVIORAL

Participants will receive instructions on stretching, range of motion, limbering, and toning. Activities will focus on flexibility enhancement. Along with the stretching and flexibility, this group will have a social interaction component. They will have discussions and interact with trainers and coordinators during all their sessions. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program.

Social Interaction Stretching (SIS)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 40 years old
• documented history of HIV infection
• on stable combination antiretroviral therapy (cART) for approximately 3 months with undetectable plasma HIV RNA
• physically inactive-sedentary lifestyle (approximately \<2 hours of exercise/week) and not engaged in regular exercise for approximately 3 months prior to enrollment
• approximately 9 years of education
• able to have an MRI
• able to provide written informed consent (does not have LAR, POA, etc.)

You may not qualify if:

• approximately \>2x/week of moderate (or greater) exercise
• cardiovascular/cerebrovascular disease or pulmonary disease that precludes ability to safely exercise
• significant neurological disorders (e.g. stroke, head injury with loss of consciousness for \>30 minutes, developmental learning disability
• presence of dementia or behavioral disorders that would prevent ability to follow the protocol
• alcohol or substance abuse/ dependence within the last 6 months (DSM-4 TR)
• contraindications to MRI scanning (e.g. claustrophobia, pacemaker)
• pregnant or breast-feeding
• unable to provide written informed consent

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Missouri, St. Louis: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (32)

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MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Motor Activity

Interventions

Exercise; Drug Interactions

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; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Results Point of Contact

• Title: Brittany Nelson, Senior Clinical Research Coordinator
• Organization: Washington University in St. Louis

bmnelson@wustl.edu

314-747-8425

Study Officials

• Beau M Ances, MD,PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2016
• First Posted: January 26, 2016
• Study Start: August 1, 2016
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: November 21, 2023
• Results First Posted: November 21, 2023

Record last verified: 2023-02

Locations

US (1)