NCT05752500Recruiting
Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults Living With HIV
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
The goal of this clinical trial is to examine 3 interventions designed to increase physical activity in older adults with HIV. We will examine 3 potential components of an intervention package: physical activity coaching, cognitive behavioral therapy targeted toward common barriers to physical activity such as low motivation or chronic pain, and a Fitbit-based social support intervention. Our primary outcome will be physical activity, defined as steps per day. Results will guide choice of intervention components to be used in an optimized behavioral intervention.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 196 (estimated)
- First submitted
- 22 Feb 2023
- Start date
- Jun 2023
- Primary completion date
- Aug 2027
- Lead sponsor
- Butler Hospital
- Diseases
- HIV
- NCT number
- NCT05752500
What you commit to
- Study type: Interventional
- Planned participants: 196
- From Jun 2023 to the primary completion date, Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Exclusion Criteria
- Medical conditions or physical or neurocognitive limitations that interfere with PA or study participation.
- 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).
Who the study is looking for
- HIV positive: defined by HIV antibody, detectable HIV RNA in plasma, or a note from the participant's HIV care provider.
- Must be on continuous antiretroviral therapy (ART) for \> 3 months, as assessed via self-report.
- 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.
- 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.
- Age 50 years or older.
- 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).
- Capacity to consent, documented by acceptable answers in a consent "teach-back" process.
- Score of greater than 16 on the MOCA
- Able to ambulate without assistive devices
- Ability to use the FitBit application, as demonstrated to study staff.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hennepin Healthcare Research Institute Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| Brown University Health Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.