Improving physical activity in older adults living with HIV

Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults Living With HIV

This study is testing three different ways to help older adults living with HIV be more active, including coaching, therapy for motivation, and a social support system using Fitbits, to see which method works best.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Butler Hospital (Academic / other)
• Locations: 2 sites (Minneapolis, Minnesota and 1 other locations)
• Trial ID: NCT05752500 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate three different interventions designed to enhance physical activity among older adults living with HIV. The interventions include physical activity coaching, cognitive behavioral therapy to address barriers such as low motivation and chronic pain, and a Fitbit-based social support system. The primary outcome measured will be the number of steps taken per day, which will help determine the most effective components for a comprehensive behavioral intervention. The study utilizes the Multiphase Optimization Strategy (MOST) framework to develop and optimize these interventions for practical application in primary care settings.

Who should consider this trial

Good fit: Ideal candidates for this study are HIV-positive individuals aged 50 and older who engage in low levels of physical activity and are medically cleared for moderate physical activity.

Not a fit: Patients who are not HIV-positive or those who are unable to engage in moderate physical activity due to severe medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved physical activity levels and overall health outcomes for older adults living with HIV.

How similar studies have performed: While there have been studies focusing on supervised exercise in HIV populations, this approach of integrating lifestyle physical activity through behavioral interventions is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. HIV positive: defined by HIV antibody, detectable HIV RNA in plasma, or a note from the participant's HIV care provider.
2. Must be on continuous antiretroviral therapy (ART) for \> 3 months, as assessed via self-report.
3. Low PA: defined as self-report of \< 90 minutes of moderate-vigorous PA (MVPA) per week in the previous 3 months AND less than 14 hours per week of sustained walking in the previous 4 weeks.
4. Medically cleared for moderate PA. If participants report a) a history of cardiovascular disease including known coronary artery disease, peripheral vascular disease, heart failure, or stroke; or b) chest pain, shortness of breath, or dizziness or syncope either at rest or during activity in the past 3 months, then they must have medical clearance by a physician or primary care provider.
5. Age 50 years or older.
6. Proficiency in English: sufficient to engage in informed consent, understand assessments and materials provided, and engage and use Fitbit application (all materials provided in English).
7. Capacity to consent, documented by acceptable answers in a consent "teach-back" process.
8. Score of greater than 16 on the MOCA
9. Able to ambulate without assistive devices
10. Ability to use the FitBit application, as demonstrated to study staff.

Exclusion Criteria:

* Exclusion Criteria

  1. Medical conditions or physical or neurocognitive limitations that interfere with PA or study participation.
  2. Hazardous substance use, assessed via a score ≥15 on the Alcohol Use Disorders Identification Test (AUDIT) or ≥6 on the Drug Abuse Screening Test (DAST).

Where this trial is running

Minneapolis, Minnesota and 1 other locations

• Hennepin Healthcare Research Institute — Minneapolis, Minnesota, United States (Recruiting)
• Brown University Health — Providence, Rhode Island, United States (Recruiting)

Study contacts

• Principal investigator: Lisa Uebelacker, PhD — Butler Hospital
• Study coordinator: Bailey O'Keeffe, MS

Conditions Hiv; Physical Inactivity; Aging