NCT06149624Completed
Supervised Treadmill Intervention to Reduce Inflammation and Depression Through Exercise in HIV: The STRIDE Pilot Study
Source: ClinicalTrials.gov · Last updated 30 May 2025
Brief summary (registry, in English)
Depression in people living with HIV is associated with worse care engagement, drug adherence, and higher rates of pre-mature mortality. The prevalence of depression is three times greater in those with HIV than comparable controls. While antiretroviral therapy (ART) enables immune reconstitution, those with depression do worse clinically than those without depression even when controlling for HIV stage. However, treating depression in HIV-infected persons is challenging. Even among those virologically suppressed on ART, a significant percentage are resistant to standard pharmacotherapy or psychotherapy for depression. The reasons for this are complex and poorly understood. An emerging body of evidence indicates that inflammation may perpetuate depression. Given people with HIV have ongoing increased inflammation, this could help explain part of why depression rates are so high in people with HIV. Treatments for HIV-associated depression would likely be more effective if they were anti- inflammatory in nature. One possible treatment is exercise. Exercise is acutely pro-inflammatory due to catabolism but in the long term is anti-inflammatory. However, few studies have investigated exercise as a treatment for HIV-associated depression. The study objective is to perform a feasibility study to evaluate a larger trial evaluating the efficacy of exercise as an intervention for depression in people with HIV.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 29 Oct 2023
- Start date
- 1 Jul 2024
- Primary completion date
- 15 Apr 2025
- Lead sponsor
- University of Minnesota
- Diseases
- HIV
- NCT number
- NCT06149624
What you commit to
- Study type: Interventional
- Participants enrolled: 22
- From 1 Jul 2024 to the primary completion date, 15 Apr 2025
- 1 site 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
- Uncontrolled hypertension (≥180 systolic or ≥100 diastolic blood pressure)
- Resting heart rate \>90/min
- Known atherosclerotic or non-atherosclerotic peripheral artery disease.
- Exercise intolerance due to other known medical condition(s) which may make it unsafe for the patients to participate in.
Other
- Women pregnant or breastfeeding
- Suicidal (PHQ-9 question 9 score \>2) or Severely Depressed (PHQ-9 score \>20)
- Lower limb orthopedic limitations (e.g. amputations, arthritis)
Who the study is looking for
- Enrolled in Mildmay HIV clinic
- Adults 18-45 years old
- HIV positive
- Receiving HIV therapy
- HIV viral suppression (\<400 copies/mL) per chart review
- Mild to Moderate (PHQ9 score \>5 but \>20)
- Not currently engaged in a formal exercise program or manual labor such as construction or delivery requiring a manual bike or walking
- Able to walk/run on a treadmill
- Informed consent
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.