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

NCT06149624 | Completed

• 1 other identifier: MED-2023-32453
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Hiv

Outcome Measures

Primary Outcomes (1)

• Percent completion of the prescribed aerobic exercise intervention

  assessed by research staff logging participation

  8 weeks

Secondary Outcomes (11)

• acceptability of the intervention

  8 weeks

• feasibility of using a wearable exercise tracker 2

  8 weeks

• feasibility of using a wearable exercise tracker 1

  8 weeks

• effect size

  baseline and 8 weeks

• effect size

  baseline and 8 weeks

Study Arms (2)

control

PLACEBO COMPARATOR

participants randomized to control group

Behavioral: upfront advice to walk

Intervention group

EXPERIMENTAL

participants randomized to intervention group

Behavioral: Supervised exercise

Interventions

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.

control

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).

Intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Depression; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Sarah Lofgren, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Ryan Mays, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Anita Arinda, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 29, 2023
• Study Start: July 1, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

US (1)