Supervised Treadmill Intervention to Reduce Inflammation and Depression Through Exercise in HIV: The STRIDE Pilot Study
- Conditions
- DepressionHiv
- Interventions
- Behavioral: upfront advice to walkBehavioral: Supervised exercise
- Registration Number
- NCT06149624
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control upfront advice to walk participants randomized to control group Intervention group Supervised exercise participants randomized to intervention group
- Primary Outcome Measures
Name Time Method Percent completion of the prescribed aerobic exercise intervention 8 weeks assessed by research staff logging participation
- Secondary Outcome Measures
Name Time Method power estimate baseline and 8 weeks - measure the mean and standard deviation of baseline and 8-week serum IL-6 level to power a future study
depression score baseline and 8 weeks depression score via PHQ-9
acceptability of the intervention 8 weeks assessed via post intervention survey
feasibility of using a wearable exercise tracker 2 8 weeks calories burned during the intervention period among Ugandans with HIV and depression
effect size baseline and 8 weeks - measure the mean and standard deviation of baseline and 8-week serum IL-6 level to estimate an effect size
feasibility of using a wearable exercise tracker 1 8 weeks assess the volume of exercise based on steps achieved, during the intervention period among Ugandans with HIV and depression
aerobic fitness Baseline and 8 weeks measure the total time/distance achieved
effect size for a future intervention Baseline and 8 weeks measure the mean and standard deviation for total time/distance to estimate the effect size for a future intervention.
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States