Clinical trial NCT06149624: Supervised Treadmill Intervention to Reduce Inflammation and Depression Through Exercise in HIV: The STRIDE Pilot Study
Official title: Supervised Treadmill Intervention to Reduce Inflammation and Depression Through Exercise in HIV: The STRIDE Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Hiv
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-11-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* Enrolled in Mildmay HIV clinic
* Adults 18-45 years old
* HIV positive
* Receiving HIV therapy
* HIV viral suppression (\&lt;400 copies/mL) per chart review
* Mild to Moderate (PHQ9 score \&gt;5 but \&gt;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.

Primary outcomes:
measure: Percent completion of the prescribed aerobic exercise intervention
timeFrame: 8 weeks
Secondary outcomes:
measure: acceptability of the intervention
timeFrame: 8 weeks
measure: feasibility of using a wearable exercise tracker 2
timeFrame: 8 weeks
measure: feasibility of using a wearable exercise tracker 1
timeFrame: 8 weeks
measure: effect size
timeFrame: baseline and 8 weeks
measure: effect size
timeFrame: baseline and 8 weeks
measure: power estimate
timeFrame: baseline and 8 weeks
measure: power estimate
timeFrame: baseline and 8 weeks
measure: depression score
timeFrame: baseline and 8 weeks
measure: aerobic fitness
timeFrame: Baseline and 8 weeks
measure: aerobic fitness
timeFrame: Baseline and 8 weeks
measure: effect size for a future intervention
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sarah Lofgren, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Ryan Mays, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Anita Arinda, PhD
role: PRINCIPAL_INVESTIGATOR
References: