Hearts and Minds in HIV

NCT ID: NCT02315742

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-04-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Let's Move Program

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

Group Type: EXPERIMENTAL

Let's Move Program

Intervention Type: 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.

Interventions

Let's Move 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Exercise program

Eligibility Criteria

Inclusion Criteria

• 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

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, 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Gary

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Gary, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

The Ponce de Leon Center of the Grady Health System

Atlanta, Georgia, United States

AbsoluteCARE, Inc.

Atlanta, Georgia, United States

Emory Hospital Infectious Diseases Clinic

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00076644

Identifier Type: -

Identifier Source: org_study_id