Clinical trial NCT02711878: Healing Hearts and Mending Minds in Older Adults Living With HIV
Official title: Healing Hearts and Mending Minds in Older Adults Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Cardiovascular Disease
AIDS
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2016-03-17
Enrollment: 115
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This is a two arm, randomized controlled trial to test the longitudinal effects of the Let's Move Program (walking for exercise) compared to effects of the attention control Let's Flex Program (stretching for exercise) in participants aged 50 to 89 years living with HIV and who have two or more cardiovascular disease risk factors. Participants in 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. Participants will participate in an in home exercise program for twelve weeks in which the study team will help identify maximum duration and intensity followed by a maintenance period for weeks 13-58.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* On oral corticosteroids (nasal, optical and inhaler corticosteroids allowed without restriction) , experiencing acute inflammation at time of baseline or follow-up testing (this will result in rescheduling of testing if no other exclusion criteria apply after 2 weeks)
* 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
* Patient Health Questionnaire-2 (PHQ-2) score \> 4
* Completed 8 years or less of school
* Failed to pass post-consent test after three attempts
* Two or more positive drug screen tests
* Alcohol breathalyzer test result \> 0.03

Primary outcomes:
measure: Stroop Color and Word Test Score
timeFrame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
measure: Trail Making Test Score
timeFrame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
measure: Letter Fluency Assessed by Change in FAS Test Score
timeFrame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
measure: Category Fluency Test Score
timeFrame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
measure: Hopkins Verbal Learning Test (HVLT) - Revised Score
timeFrame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
measure: Brief Visual Memory Test - Revised (BVMT-R) Score
timeFrame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
measure: Grooved Pegboard Test Score
timeFrame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
measure: Finger Tapping Test Score
timeFrame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
measure: Coding Test Score
timeFrame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
measure: Digit Span Test Score
timeFrame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
measure: Symbol Span Test Score
timeFrame: Baseline, 3 months, 6 months and 12 months Post Intervention
measure: Instrumental Activities of Daily Living (IADL) Test Score
timeFrame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
measure: NIH Toolbox
timeFrame: Baseline, Post Intervention (Up to 58 weeks)
Secondary outcomes:
measure: Soluble Cluster of Differentiation 14 (sCD14) Level
timeFrame: Baseline, T1 (13-15 weeks), T2 (28-30 weeks), T3 (56 -58 weeks)
measure: Interleukin 6 (IL-6) Level
timeFrame: Baseline, T1 (13-15 Weeks), T2 (28-30 weeks), T3 (56-58 weeks)
measure: Tumor Necrosis Factor Alpha (TNF-alpha) Level
timeFrame: Baseline, T1 (13-15 wks), T2 (28-30 wks), T3 (56-58 wks)
measure: Brain-derived Neurotrophic Factor (BDNF) Level
timeFrame: Baseline, Post Intervention (Up to 58 weeks)
measure: Flow-Mediated Dilatation (FMD)
timeFrame: Baseline, T2 (28-30 weeks post baseline)
Other outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
measure: Beck Depression Inventory-II (BDI-II) Score
timeFrame: Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
measure: Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
timeFrame: Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
measure: V02 Max Rate
timeFrame: Baseline
measure: Six-minute Walk Test
timeFrame: Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Ponce De Leon Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Drenna Waldrop-Valverde, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Rebecca Gary, PhD
role: PRINCIPAL_INVESTIGATOR
References: