Hearts and Minds in HIV

NCT02315742 | Completed

• 1 other identifier: IRB00076644
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Baseline, 3 months, 6 months

• Executive function as measured by attention switching task (AST) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)

  Baseline, 3 months, 6 months

• Memory function as measured by delayed matching to sample (DMS) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)

  Baseline, 3 months, 6 months

• Memory function as measured by visual recognition memory (VRM) of the Cambridge Neuropsychological Test Automated Battery (CANTAB)

  Baseline, 3 months, 6 months

• Information processing speed as measured by choice reaction time (CRT)

  Baseline, 3 months, 6 months

Study Arms (1)

Let's Move Program

EXPERIMENTAL

Patients will take part in a 12-week exercise program.

Behavioral: Let's Move Program

Interventions

Let's Move Program BEHAVIORAL

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.

Also known as: Exercise program

Let's Move Program

Eligibility Criteria

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

You may qualify if:

• 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

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, 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
• presence of current opportunistic infection
• any terminal illness
• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

The Ponce de Leon Center of the Grady Health System

Atlanta, Georgia, 30308, United States

Location

AbsoluteCARE, Inc.

Atlanta, Georgia, 30309, United States

Location

Emory Hospital Infectious Diseases Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rebecca Gary, RN, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 12, 2014
• Study Start: February 1, 2016
• Primary Completion: March 10, 2017
• Study Completion: April 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

US (3)