Healing Hearts and Mending Minds in Older Adults Living With HIV

NCT02711878 | Completed Results DMC

• 2 other identifiers: IRB000803021R01NR014973-01
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to see if exercise is helpful for improving memory, concentration thinking abilities, physical function, and quality of life for adults aged 50 to 89 years living with HIV and who have two or more cardiovascular disease risk factors. The study will test two kinds of intervention exercises: one group will walk for exercise and the second group will stretch for exercise. Members of both interventions will be asked to participate in one-on-one interviews/assessments, measures of physical functioning, and some sessions with others who are also enrolled in the study.

Conditions

HIV; Cardiovascular Disease; AIDS

Outcome Measures

Primary Outcomes (13)

• Stroop Color and Word Test Score

  The Stroop Color and Word Test is a performance-based test of executive function and inhibitory responding. The participant is presented with a page with the words "red, blue, and green" printed 100 times in (20 words in 5 columns). Each word is printed in a different color of ink than the target word (e.g, the word "red" is printed in blue ink). Participants read the color of ink in which the word is printed as quickly are possible within a time limit. The correct number within the time limit is the score. Raw scores (unadjusted for age and education) range from 0-100.

  Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

• Trail Making Test Score

  The Trail Making Test is a performance based test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect circles as possible while still maintaining accuracy. Trails A subtest requires the connection in sequence of 25 circles labeled by numbers. Trails B requires the connection in sequence of 25 circles labeled by alternating numbers and letters (1-A-2-B-3-C). The score on the test is the time in seconds that it takes to complete. Higher scores (i.e., time) indicate poorer performance.

  Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

• Letter Fluency Assessed by Change in FAS Test Score

  The FAS test requires stating out loud as many words that begin with the assigned letter (F, A, and S) as possible within 60-seconds. Results represent total number of words stated for F,A \& S combined.

  Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

• Category Fluency Test Score

  The category fluency test requires participants to state out load the names of as many animals as possible within 60-seconds. Results are total number of animals named.

  Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

• Hopkins Verbal Learning Test (HVLT) - Revised Score

  The HVLT-Revised is a list learning task requiring the respondent to recall as many words as possible from a list of 12 words provided orally by the examiner. There is a learning trial, a delayed recall trial, and a recognition trial. Results show HVLT Total recall (Total number if words recalled over 3 trials) and HVLT Delayed recall (Total number of words recalled after 25 minute delay).

  Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

• Brief Visual Memory Test - Revised (BVMT-R) Score

  The Brief Visual Memory Test is a performance based test that requires that participants reproduce simple visual images from memory (the images are displayed for 10 seconds then removed from view). The BVMT-R contains a learning trial, a recall trial, a recognition trial, and a copy trial. Each figure recalled is given 0,1, or 2 points based on accuracy and location recall. Results show BVMT Total recall (Total number if figures recalled over 3 trials: range 0 - 36) and BVMT delayed recall (total number of figures recalled after 25 min delay. Score range 0-12). Higher score correlate with better outcome.

  Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

• Grooved Pegboard Test Score

  The Grooved Pegboard Test requires the placing of grooved pegs into a same-shaped hole as quickly as possible, once with the dominant hand and once with the non-dominant hand.

  Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

• Finger Tapping Test Score

  The finger tapping test a fine motor speed requires tapping a lever with the index finger as quickly as possible. Trials with the dominant and non-dominant hand are completed.

  Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

• Coding Test Score

  The coding test requires writing the corresponding symbol associated with a letter from a key provided. As many responses as possible are completed in the 120 second time limit. Results presented are the total number of correct responses (possible score range 0-135).

  Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

• Digit Span Test Score

  The digit span test is a performance based test that requires repeating an increasing span of digits that are provided verbally by the examiner. The test includes trials of repeating digits in the same order presented by the examiner, in the reverse order of that presented by the examiner, and in ascending sequence. Scores range from 0 to 48. Higher score correlates with better outcome.

  Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)

• Symbol Span Test Score

  The subtest assesses visual working memory using novel visual stimuli. A series of abstract symbols on a page are shown briefly. Then the symbols are to be selected from an array of symbols in the same order they were presented on the previous page. This performance based test measures storage and manipulation of visual details in working memory. Score range from 0-36. Higher score correlates with better outcome.

  Baseline, 3 months, 6 months and 12 months Post Intervention

• Instrumental Activities of Daily Living (IADL) Test Score

  The Instrumental Activities of Daily Living (IADL) Test is a self-report measure assessing the amount of assistance, if any, required to do day-to-day tasks necessary to live independently. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias). Higher scores indicate worse performance in instrumental activities activities of daily living.

  Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)

• NIH Toolbox

  Computerized cognitive tests developed and distributed by the NIH. Tests include Pattern Comparison Processing Speed Test, Picture Vocabulary Test, Reading Recognition Test, Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, List Sorting Working Memory Test, and Oral Symbol Digit Test

  Baseline, Post Intervention (Up to 58 weeks)

Secondary Outcomes (5)

• Soluble Cluster of Differentiation 14 (sCD14) Level

  Baseline, T1 (13-15 weeks), T2 (28-30 weeks), T3 (56 -58 weeks)

• Interleukin 6 (IL-6) Level

  Baseline, T1 (13-15 Weeks), T2 (28-30 weeks), T3 (56-58 weeks)

• Tumor Necrosis Factor Alpha (TNF-alpha) Level

  Baseline, T1 (13-15 wks), T2 (28-30 wks), T3 (56-58 wks)

• Brain-derived Neurotrophic Factor (BDNF) Level

  Baseline, Post Intervention (Up to 58 weeks)

• Flow-Mediated Dilatation (FMD)

  Baseline, T2 (28-30 weeks post baseline)

Other Outcomes (5)

• Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)

• Beck Depression Inventory-II (BDI-II) Score

  Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)

• Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire

  Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)

Study Arms (2)

Let's Move Program

EXPERIMENTAL

Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks.

Behavioral: Let's Move Program; Behavioral: Group Motivational Interviewing

Let's Flex Program

ACTIVE COMPARATOR

Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks.

Behavioral: Let's Flex Program; Behavioral: Group Motivational Interviewing

Interventions

Let's Move Program BEHAVIORAL

Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.

Let's Move Program

Let's Flex Program BEHAVIORAL

Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.

Let's Flex Program

Group Motivational Interviewing BEHAVIORAL

Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.

Let's Flex Program; Let's Move Program

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV diagnosis
• English speaking
• Live independently within a 30-45 mile radius of Atlanta, Georgia
• Not involved in any structured exercise program or exercising 3 or more times per week for a minimum of 30 minutes
• Not involved in any weight loss program
• Not hospitalized within the last 60-days
• Clinically stable and on antiretroviral therapy (ART) 6 months before enrollment
• If taking statins, stable on medication for 3 months
• Score 3 or less on the verbal memory subtest of the Montreal Cognitive Assessment (MoCA)
• Less than 0.5 standard deviations (SD) below mean on the Oral Trail Making Test B
• Able to provide informed consent and pass a consent post-test

You may not qualify if:

• Non sedentary (defined as engaging in \> 30 minutes of moderately strenuous exercise 3 times or more a week)
• Medical or physical condition that would preclude participation in the exercise component of the study (e.g., severe arthritis or mobility problems, lower extremity amputations, joint replacement(s), balance disorders, dizziness, dyspnea on exertion (DOE) with moderate exertion, difficulty walking one block, recent falls, obvious injury to lower extremity, uncontrolled hypertension or diabetes, renal failure, blindness, or a history of angina with activity)
• Ischemic changes or inappropriate BP changes on baseline exercise (modified Balke or Bruce) treadmill test
• Presence of current opportunistic infection
• Any terminal illness
• Regular use of anti-inflammatory medications such as non-steroidal anti-inflammatory agents excluding low dose aspirin
• On anti-psychotics
• On tricyclic antidepressants
• On anti-depressants equal to the equivalent of more than 1 mg of Clonazepam
• On Lithium
• Women who are pregnant
• Severe learning disabilities, intellectual disabilities, schizophrenia, bipolar, psychotic disorders to minimize confounding effects on neurocognitive data
• Confounding neuro-medical conditions (e.g., active central nervous system (CNS) opportunistic infections, seizure disorders, head injury with loss of consciousness greater than 30 minutes, intracranial neoplasms, stroke with neurological or neuropsychiatric sequelae, and non-HIV-associated dementias)
• Meet criteria for any Substance Use Disorder or Major Depression within 6 months of evaluation
• Creatinine \> 2.5 within the past 6 months

Sponsors & Collaborators

• Emory University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (3)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Ponce De Leon Center

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Acquired Immunodeficiency Syndrome

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

Results Point of Contact

• Title: Dr. Eun Ok IM
• Organization: Emory university

eun.ok.im@emory.edu

404-712-9805

Study Officials

• Drenna Waldrop-Valverde, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Rebecca Gary, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 17, 2016
• Study Start: September 1, 2016
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: July 6, 2023
• Results First Posted: July 1, 2022

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)