HIVNCT02315742
Hearts and Minds in HIV
A study testing Let's Move Program in people with HIV, run by Emory University at 3 sites in United States.
Trial summary
The purpose of this study is to see if walking is effective for improving memory, concentration thinking abilities, physical function and quality of life of adults 50 years of age and older living with HIV. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Let's Move Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women aged 50 and over with 2 CVD risk factors (i.e., obesity, hypertension, hyperlipidemia) who are diagnosed with HIV/AIDS and willing to participate
- English speaking
- live independently and within a 30 mile radius of Atlanta
- 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 (absence of viral load and no active opportunistic infection), on ART 6 months before enrollment and a screening MOCA score ≤ 24 indicating mild cognitive impairment
Who cannot join
- 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, uncontrolled hypertension or diabetes, renal failure, or a history of angina with activity
- ischemic changes or inappropriate BP changes on BL exercise (modified Balke) treadmill test
- on corticosteroids, experiencing acute inflammation at time of baseline or follow-up testing (this will result in rescheduling of testing if no other exclusion criteria apply)
- presence of current opportunistic infection
- any terminal illness
Show all 11Show fewer
- regular use of anti-inflammatory medications such as non-steroidal anti-inflammatory agents
- women who are pregnant
- severe learning disabilities, intellectual disabilities, psychotic disorders to minimize confounding effects on neurocognitive data
- confounding neuro-medical conditions (e.g., active 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)
- active substance abuse and major depression
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Ponce de Leon Center of the Grady Health System
Atlanta, Georgia, 30308
AbsoluteCARE, Inc.
Atlanta, Georgia, 30309
Emory Hospital Infectious Diseases Clinic
Atlanta, Georgia, 30322
About this study
Official title: Healing Hearts and Mending Minds in Older Persons Living With HIV
The purpose of this study is to see if walking is effective for improving memory, concentration thinking abilities, physical function and quality of life of adults 50 years of age and older living with HIV.
Read the detailed description
By 2015 more than half of persons living with HIV (PLWH) in the U.S. will be older than 50 years of age. Two factors contribute to the "graying" of the HIV epidemic. The overwhelming success of antiretroviral therapy (ART) has improved life expectancy and dramatically changed the trajectory of HIV; it is now a complex chronic condition, often associated with multiple comorbidities such as cardiovascular disease (CVD) and cognitive impairment (CI). Second, increasing numbers of middle-aged and older adults are becoming infected with HIV. Clinicians, patients, and society are currently ill-prepared to deal with the biomedical complexities and unique medical and psychosocial challenges associated with the growing aging HIV population.
Aerobic exercise or exercise that speeds up the heart rate lowers CVD risk, and is known to improve physical and mental function with aging, but few well designed studies have reported use of aerobic exercise interventions in PLWH, and no studies have reported whether exercise improves cognitive function in this high risk for CI population. Regular aerobic exercise performed 5 times per week for 150 minutes has also been shown to improve aspects of cognitive function in community-dwelling older adults. Only one exercise study however, has examined the effect of exercise on cognition in PLWH and was limited by a self-reported, unreliable indicator of cognitive status; no studies have reported whether exercise improves cognition in this population using objective assessments, or examined the potential mechanisms involved.
The home-based, 5 day per week moderate intensity walking intervention, the 'Let's Move Program,' has been tested and is effective for lowering CVD risk older caregivers and adults with advanced CVD. The proposed pre-post test pilot study will examine the feasibility of implementing the Lets Move Program among 40 PLWH over 6-months. Participants enrolled in the study will be ≥ 50 years of age, sedentary, have 2 CVD risk factors such as high blood pressure and obesity and demonstrate mild to moderate CI using standardized tests. Motivational Interviewing (MI) will be used to promote exercise confidence and optimize adherence to the intervention.
- Conditions
- HIV
- Being tested
- Let's Move Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let's Move ProgramBehavioural
Also called Exercise program
Patients will walk 5 times per week for 12 weeks for a minimum of 30 minutes while using a heart rate monitor. After the first two weeks of walking, patients will attend four consecutive group meetings which a research team member will look at walking logs and download data from heart rate monitor to focus on progress. Patient will receive weekly phone calls to monitor progress and to change walking duration or intensity level.
| Study group | Role | What they receive |
|---|---|---|
| Let's Move Program | Experimental | Patients will take part in a 12-week exercise program. Receives: Behavioral: Let's Move Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive function as measured by stop signal task (SST) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
SST is a commonly used test of response inhibition. This test consists of two parts. In the first part, the subject is introduced to the press pad, and told to press the left hand button when they see a left-pointing arrow or press the right hand button when they see a right-pointing arrow. There is one block of 16 trials for the subject to practice this. In the second part, the subject is told to continue pressing the buttons on the press pad when they see the arrows, as before, but, if they hear an auditory signal (a beep), they should withhold their response and not press the button.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (20)
Executive function as measured by spatial working memory (SWM) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
SWM is a computerized assessment of working memory and strategy performance. The subject is required to find blue "tokens" in various displayed boxes and use the "tokens" to fill a column on the right side of the screen. Subjects can only find "tokens" in new boxes, therefore they must remember where previous "tokens" were found. SWM scores including number of between errors, number of within errors, and number of double errors range 0-800 and SWM strategy scores range 8-56. Lower scores indicate better performance.
Measured: Baseline, 3 months, 6 months
Executive function as measured by attention switching task (AST) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
AST is a test of the participant's ability to switch attention between the direction or location of an arrow on screen. This test is a sensitive measure of frontal lobe and 'executive' dysfunction. The test begins with an arrow in the centre of the screen which points either to the left or to the right. The participant is introduced to two buttons, one on the left and one on the right, and is asked to press a button corresponding to the direction in which the arrow is pointing.
After this initial training, the participant is then told that the arrow might appear on the left or the right side of the screen, and depending on the cue given at the top of the screen, the participant must either press the left or right button to indicate on which side of the screen the arrow is displayed, or else press the left or right button to correspond with the direction in which the arrow is pointing.
Measured: Baseline, 3 months, 6 months
Memory function as measured by delayed matching to sample (DMS) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
DMS has 19 outcome measures, assessing latency (the participant's speed of response), the numbers of correct patterns selected, and statistical analysis measuring the probability of an error after a correct or incorrect response.
Measured: Baseline, 3 months, 6 months
Memory function as measured by visual recognition memory (VRM) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
During VRM, the participant is shown a list of words and then asked to recognize the words they have seen before from a list containing the original words and distractors. The five outcome measures for VRM cover correct and incorrect responses for the recognition and free recall parts of the test.
Measured: Baseline, 3 months, 6 months
Information processing speed as measured by choice reaction time (CRT)
Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.
Measured: Baseline, 3 months, 6 months
Interleukin 6 (IL-6) Levels
IL-6 is a pro-inflammatory cytokine known to contribute to the pathogenesis of risk of CVD and CI through inflammation and promotion of endothelial vascular dysfunction. IL-6 is measured by enzyme-linked immunosorbent assay (ELISA) and reported as in picograms per deciliter (pg/dL). Higher concentrations of IL-6 raise CHD risk.
Measured: Baseline, 3 months, 6 months
Soluble CD14 (sCD14) Levels
sCD14 is a marker of monocyte activation, associated with neurocognitive impairment and HIV-associated neurological disorders (HANDs) and higher mortality in PLWH
Measured: Baseline, 3 months, 6 months
D-Dimer Levels
D-Dimer is a marker of procoagulation, associated with increased risk for CVD and neurocognitive decline in older adults. High concentrations of D-dimer have been linked prospectively to onset of CVD and reported as in nanograms per milliliter (ng/mL).
Measured: Baseline, 3 months, 6 months
Brain-derived Neurotrophic Factor (BDNF) Levels
BDNF is a protein that occurs naturally in the hippocampus, cortex, and basal forebrain-areas vital to learning, memory, and higher thinking; an increase in BDNF in animal models and humans is thought to enhance neurogenesis. BDNF is reported as in nanograms per milliliter (ng/mL).
Measured: Baseline, 3 months, 6 months
Flow-Mediated Dilation
Flow-mediated dilation of the brachial artery will be measured using high-resolution ultrasound. Arterial diameter will be measured above the small cavity in the elbow joint from ultrasound images at rest in response to an increase in blood flow to the area.
Measured: Baseline, 3 months, 6 months
V02 max
V02 max is the maximum rate of oxygen consumption as measured during incremental exercise using the Balke treadmill test.
Measured: Baseline, 3 months, 6 months
Beck Depression Inventory-II (BDI-II)
BDI-II is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Each answer being scored on a scale value of 0 to 3.
Measured: Baseline, 3 months, 6 months
Health-related Quality of Life (HRQoL)
HRQoL is an assessment of how the individual's well-being may be affected over time by a disease, disability, or disorder.
Measured: Baseline, 3 months, 6 months
Exercise Adherence (number of exercise sessions recorded/number of sessions prescribed) × 100)
Exercise Adherence is the extent to which a patient acts in accordance with the advised interval, exercise dose, and exercise dosing regimen (number of exercise sessions recorded/number of sessions prescribed) × 100.
Measured: Baseline, 3 months, 6 months
Steps (measure of walking by a FitBit device)
Steps is the measure of walking by a FitBit device.
Measured: Baseline, 3 months, 6 months
Step Calendar (document participants will be asked to record)
Step Calendar is a document participants will be asked to record: maximum HR, highest rate of perceived exertion (RPE) during walk, and number of steps walked during the walking sessions.
Measured: Baseline, 3 months, 6 months
Borg Rate of Perceived Exertion (RPE) Scale
RPE is a well-established 15 point (6-20) scale used to measure exertion.
Measured: Baseline, 3 months, 6 months
Target heart range (THR)
THR will be used to monitor the intensity and training response to walking. Target exercise rate will equal peak HR established from CPET (Peak HR) X (0.60 to 0.70). Polar Beat Watch (FT 1) will be used to monitor intensity and duration for the aerobic training.
Measured: Baseline, 3 months, 6 months
Exercise Self Efficacy scale
Exercise Self Efficacy scale is the 18 item scale to measure exercise self-efficacy. Scores range from 0 to 100 with higher scores reflecting greater self-efficacy.
Measured: Baseline, 3 months, 6 months
Outcome Expectations for Exercise Scale (OEE)
OEE is a 9 item scale, with established validity and reliability in older adults and African American's will be used to measure outcome expectations.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startFeb 2016
- Primary completion10 Mar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Gary, Emory University
- Investigators
- Rebecca Gary, RN, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315742
- Sponsor's protocol ID
- IRB00076644
- Status last verified
- May 2017
- First submitted
- 9 Dec 2014
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Hearts and Mending Minds in Older Persons Living With HIV
- ClinicalTrials.gov ID
- NCT02315742
- Acronym / sponsor ID
- IRB00076644
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if walking is effective for improving memory, concentration thinking abilities, physical function and quality of life of adults 50 years of age and older living with HIV.
Detailed description
By 2015 more than half of persons living with HIV (PLWH) in the U.S. will be older than 50 years of age. Two factors contribute to the "graying" of the HIV epidemic. The overwhelming success of antiretroviral therapy (ART) has improved life expectancy and dramatically changed the trajectory of HIV; it is now a complex chronic condition, often associated with multiple comorbidities such as cardiovascular disease (CVD) and cognitive impairment (CI). Second, increasing numbers of middle-aged and older adults are becoming infected with HIV. Clinicians, patients, and society are currently ill-prepared to deal with the biomedical complexities and unique medical and psychosocial challenges associated with the growing aging HIV population.
Aerobic exercise or exercise that speeds up the heart rate lowers CVD risk, and is known to improve physical and mental function with aging, but few well designed studies have reported use of aerobic exercise interventions in PLWH, and no studies have reported whether exercise improves cognitive function in this high risk for CI population. Regular aerobic exercise performed 5 times per week for 150 minutes has also been shown to improve aspects of cognitive function in community-dwelling older adults. Only one exercise study however, has examined the effect of exercise on cognition in PLWH and was limited by a self-reported, unreliable indicator of cognitive status; no studies have reported whether exercise improves cognition in this population using objective assessments, or examined the potential mechanisms involved.
The home-based, 5 day per week moderate intensity walking intervention, the 'Let's Move Program,' has been tested and is effective for lowering CVD risk older caregivers and adults with advanced CVD. The proposed pre-post test pilot study will examine the feasibility of implementing the Lets Move Program among 40 PLWH over 6-months. Participants enrolled in the study will be ≥ 50 years of age, sedentary, have 2 CVD risk factors such as high blood pressure and obesity and demonstrate mild to moderate CI using standardized tests. Motivational Interviewing (MI) will be used to promote exercise confidence and optimize adherence to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Let's Move Program | Experimental | Behavioral: Let's Move ProgramPatients will take part in a 12-week exercise program. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- men and women aged 50 and over with 2 CVD risk factors (i.e., obesity, hypertension, hyperlipidemia) who are diagnosed with HIV/AIDS and willing to participate
- English speaking
- live independently and within a 30 mile radius of Atlanta
- 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
Key exclusion criteria (11 listed)
- 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, uncontrolled hypertension or diabetes, renal failure, or a history of angina with activity
- ischemic changes or inappropriate BP changes on BL exercise (modified Balke) treadmill test
- on corticosteroids, experiencing acute inflammation at time of baseline or follow-up testing (this will result in rescheduling of testing if no other exclusion criteria apply)
- presence of current opportunistic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Let's Move ProgramAlso: Exercise programPatients will walk 5 times per week for 12 weeks for a minimum of 30 minutes while using a heart rate monitor. After the first two weeks of walking, patients will attend four consecutive group meetings which a research team member will look at walking logs and download data from heart rate monitor to focus on progress. Patient will receive weekly phone calls to monitor progress and to change walking duration or intensity level. | Behavioural | Let's Move Program |
Primary outcome
Executive function as measured by stop signal task (SST) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Baseline, 3 months, 6 months
SST is a commonly used test of response inhibition. This test consists of two parts. In the first part, the subject is introduced to the press pad, and told to press the left hand button when they see a left-pointing arrow or press the right hand button when they see a right-pointing arrow. There is one block of 16 trials for the subject to practice this. In the second part, the subject is told to continue pressing the buttons on the press pad when they see the arrows, as before, but, if they hear an auditory signal (a beep), they should withhold their response and not press the button.
20 secondary outcomes
Executive function as measured by spatial working memory (SWM) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Baseline, 3 months, 6 months
Executive function as measured by attention switching task (AST) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Baseline, 3 months, 6 months
Memory function as measured by delayed matching to sample (DMS) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Baseline, 3 months, 6 months
Memory function as measured by visual recognition memory (VRM) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Baseline, 3 months, 6 months
Information processing speed as measured by choice reaction time (CRT)
Time frame: Baseline, 3 months, 6 months
Interleukin 6 (IL-6) Levels
Time frame: Baseline, 3 months, 6 months
Soluble CD14 (sCD14) Levels
Time frame: Baseline, 3 months, 6 months
D-Dimer Levels
Time frame: Baseline, 3 months, 6 months
Brain-derived Neurotrophic Factor (BDNF) Levels
Time frame: Baseline, 3 months, 6 months
Flow-Mediated Dilation
Time frame: Baseline, 3 months, 6 months
V02 max
Time frame: Baseline, 3 months, 6 months
Beck Depression Inventory-II (BDI-II)
Time frame: Baseline, 3 months, 6 months
Health-related Quality of Life (HRQoL)
Time frame: Baseline, 3 months, 6 months
Exercise Adherence (number of exercise sessions recorded/number of sessions prescribed) × 100)
Time frame: Baseline, 3 months, 6 months
Steps (measure of walking by a FitBit device)
Time frame: Baseline, 3 months, 6 months
Step Calendar (document participants will be asked to record)
Time frame: Baseline, 3 months, 6 months
Borg Rate of Perceived Exertion (RPE) Scale
Time frame: Baseline, 3 months, 6 months
Target heart range (THR)
Time frame: Baseline, 3 months, 6 months
Exercise Self Efficacy scale
Time frame: Baseline, 3 months, 6 months
Outcome Expectations for Exercise Scale (OEE)
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Gary, RN, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let's Move Program in people with HIV, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive function as measured by stop signal task (SST) of the Cambridge Neuropsychological Test Automated Battery (CANTAB) (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.