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Clinical Trials/NCT06149624
NCT06149624
Completed
Not Applicable

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

University of Minnesota1 site in 1 country22 target enrollmentJuly 1, 2024
ConditionsDepressionHiv

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Minnesota
Enrollment
22
Locations
1
Primary Endpoint
Percent completion of the prescribed aerobic exercise intervention
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
April 15, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Percent completion of the prescribed aerobic exercise intervention

Time Frame: 8 weeks

assessed by research staff logging participation

Secondary Outcomes

  • power estimate(baseline and 8 weeks)
  • depression score(baseline and 8 weeks)
  • acceptability of the intervention(8 weeks)
  • feasibility of using a wearable exercise tracker 2(8 weeks)
  • effect size(baseline and 8 weeks)
  • feasibility of using a wearable exercise tracker 1(8 weeks)
  • aerobic fitness(Baseline and 8 weeks)
  • effect size for a future intervention(Baseline and 8 weeks)

Study Sites (1)

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