Supervised Treadmill Intervention to Reduce Inflammation and Depression Through Exercise in HIV: The STRIDE Pilot Study

Last updated: May 28, 2025
Sponsor: University of Minnesota
Overall Status: Completed

Phase

N/A

Condition

Hiv

Inflammation

Depression

Treatment

upfront advice to walk

Supervised exercise

Clinical Study ID

NCT06149624
MED-2023-32453
  • Ages 18-45
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 asconstruction or delivery requiring a manual bike or walking

  • Able to walk/run on a treadmill

  • Informed consent

Exclusion

Exclusion Criteria:

  • Women pregnant or breastfeeding

  • Suicidal (PHQ-9 question 9 score >2) or Severely Depressed (PHQ-9 score >20)

  • Uncontrolled hypertension (≥180 systolic or ≥100 diastolic blood pressure)

  • Lower limb orthopedic limitations (e.g. amputations, arthritis)

  • 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 itunsafe for the patients to participate in.

Study Design

Total Participants: 22
Treatment Group(s): 2
Primary Treatment: upfront advice to walk
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
April 15, 2025

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Site Not Available

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