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NCT06149624 | RECRUITING | Depression

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

The University of Minnesota

Brief 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.

Condition or disease

Depression

Hiv

Intervention/treatment

upfront advice to walk

Supervised exercise

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : SINGLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Supervised Treadmill Intervention to Reduce Inflammation and Depression Through Exercise in HIV: The STRIDE Pilot Study
Actual Study Start Date : 2024-07-01
Estimated Primary Completion Date : 2025-05-01
Estimated Study Completion Date : 2025-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 as construction or delivery requiring a manual bike or walking
  • * Able to walk/run on a treadmill
  • * Informed consent
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 it unsafe for the patients to participate in.
Supervised Treadmill Intervention to Reduce Inflammation and Depression Through Exercise in HIV: The STRIDE Pilot Study

Location Details

NCT06149624

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Locations

RECRUITING

United States, Minnesota

The University of Minnesota

Minneapolis, Minnesota, United States, 55414