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Search / Trial NCT05752500

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

Launched by BUTLER HOSPITAL · Feb 22, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is focused on finding the best ways to help older adults living with HIV become more physically active. Researchers are testing three different approaches: personalized coaching to encourage physical activity, therapy to help overcome common obstacles like low motivation or pain, and a social support system using a Fitbit device to connect participants with others. The main goal is to measure how much these participants increase their daily steps, which will help determine the most effective methods for improving physical activity.

To be eligible for the study, participants need to be at least 50 years old, be living with HIV, and have been on treatment for at least three months. They should also be doing very little physical activity—less than 90 minutes of moderate exercise each week. Participants must be able to walk without help and understand English well enough to follow instructions and use a Fitbit. Throughout the study, participants can expect support as they try to increase their activity levels and improve their health.

Gender

ALL

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).

About Butler Hospital

Butler Hospital is a leading psychiatric and behavioral health facility dedicated to advancing mental health care through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital focuses on developing and evaluating new therapeutic interventions, aiming to improve treatment outcomes for patients with various mental health conditions. With a commitment to evidence-based practice, Butler Hospital collaborates with a multidisciplinary team of experts to ensure rigorous methodology and ethical standards in all research endeavors, ultimately enhancing the quality of care for individuals in need.

Locations

Minneapolis, Minnesota, United States

Providence, Rhode Island, United States

Patients applied

0 patients applied

Trial Officials

Lisa Uebelacker, PhD

Principal Investigator

Butler Hospital

Jason Baker, MD

Principal Investigator

Hennepin Healthcare

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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