Anxiety & Depression Association of America

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

Purpose

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.

Conditions

Depression
Hiv

Eligibility

Eligible Ages: Between 18 Years and 45 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Masking: Single (Care Provider)

Arm Groups

Arm	Description	Assigned Intervention
Placebo Comparator control	participants randomized to control group	Behavioral: upfront advice to walk 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.
Experimental Intervention group	participants randomized to intervention group	Behavioral: Supervised exercise 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).

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of Minnesota

Study Contact

Sarah Lofgren, PhD
+1507-401-1624
lofg0020@umn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.