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Completed

NCT Number: NCT06149624

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

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.

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Key information

Conditions

Depression Acquired Immunodeficiency Syndrome Behavior Behavioral Symptoms Blood-Borne Infections Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

upfront advice to walk

Behavioral

Control participants will be given upfront advice to walk and also given the wearable activity monitor (Fitbit) and asked to record the total steps achieved each day in a provided log book.

Supervised exercise

Behavioral

The onsite physiotherapist will also be trained in appropriate supervision and monitoring of exercise therapy in participants with HIV. This training will include titration of the exercise prescription to ensure safe progress is achieved. Participants will be scheduled to come to Mildmay 2 times per week for eight weeks to perform treadmill walking exercise. Intensity will be regulated using 40-60% of heart rate reserve. Additionally, ratings of perceived exertion via the Adult OMNI Walk/Run Scale will be used to guide the intensity of exercise subjectively at a moderate level. The exercise dose participants complete are standard prescriptions for participants with HIV, according to the American College of Sports Medicine.19 The physiotherapist will document the total steps achieved, including the supervised treadmill sessions and activity completed outside the supervised exercise setting (provided by participants via a log book).

Primary outcomes

  1. Percent completion of the prescribed aerobic exercise intervention

    Time frame: 8 weeks

    assessed by research staff logging participation

Secondary outcomes

  1. acceptability of the intervention

    Time frame: 8 weeks

    assessed via post intervention survey

  2. feasibility of using a wearable exercise tracker 2

    Time frame: 8 weeks

    calories burned during the intervention period among Ugandans with HIV and depression

  3. feasibility of using a wearable exercise tracker 1

    Time frame: 8 weeks

    assess the volume of exercise based on steps achieved, during the intervention period among Ugandans with HIV and depression

  4. effect size

    Time frame: baseline and 8 weeks

    • measure the mean and standard deviation of baseline and 8-week serum BDNF level to estimate an effect size

  5. effect size

    Time frame: baseline and 8 weeks

    • measure the mean and standard deviation of baseline and 8-week serum IL-6 level to estimate an effect size

  6. power estimate

    Time frame: baseline and 8 weeks

    • measure the mean and standard deviation of baseline and 8-week serum BDNF to power a future study

  7. power estimate

    Time frame: baseline and 8 weeks

    • measure the mean and standard deviation of baseline and 8-week serum IL-6 level to power a future study

  8. depression score

    Time frame: baseline and 8 weeks

    depression score via PHQ-9

  9. aerobic fitness

    Time frame: Baseline and 8 weeks

    measure the mean aerobic fitness at baseline and at 8 weeks measured via METS/watts achieved

  10. aerobic fitness

    Time frame: Baseline and 8 weeks

    measure the total time/distance achieved

  11. effect size for a future intervention

    Time frame: Baseline and 8 weeks

    measure the mean and standard deviation for total time/distance to estimate the effect size for a future intervention.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2023
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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