Supervised Exercise for Depression in HIV

Overseen By Sarah Lofgren, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must be taking: Antiretrovirals

Disqualifiers: Pregnancy, Suicidal, Hypertension, Orthopedic, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether regular exercise can reduce depression in people living with HIV. Since individuals with HIV often experience higher inflammation levels, exercise might help by lowering inflammation over time. Participants will join either a supervised treadmill exercise group (Supervised Treadmill Intervention) or a control group that does not exercise. Those with controlled HIV, experiencing mild to moderate depression, and not currently in a formal exercise program might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore the potential mental health benefits of exercise for those living with HIV.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this exercise intervention is safe for people with HIV?

Research has shown that supervised aerobic exercise can help reduce depression symptoms in people with HIV. One study found that adults with HIV who participated in a supervised exercise program experienced fewer depression symptoms than those who did not exercise. Aerobic exercise, such as walking on a treadmill, is generally safe and easy for most people.

Other studies have examined the safety of aerobic exercise for people with HIV. These studies found that exercise improves overall health without causing major side effects. It can enhance heart health and strength, which are important for everyone.

In summary, supervised treadmill exercise appears to be a safe way to help manage depression in people with HIV. Most people can do it without problems, and it might improve both mood and health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the supervised treadmill intervention for depression in people with HIV because it offers a non-pharmacological approach, differing from standard treatments like antidepressants. This exercise-based method could reduce medication side effects and enhance mental health through physical activity, potentially boosting mood and overall well-being. Additionally, this intervention might improve adherence and engagement, as it provides structured, supervised sessions that could lead to more consistent results.

What evidence suggests that supervised treadmill intervention might be an effective treatment for depression in people with HIV?

Research has shown that exercise can help reduce depression symptoms, especially in people with HIV. In this trial, participants in the intervention group will receive a supervised treadmill exercise program. One study found that a 12-week supervised aerobic exercise program significantly reduced depression in adults with HIV compared to those who did not exercise. Other studies have also found that physical activity can help with depression and anxiety, with a moderate effect on reducing symptoms. Exercise may help because it lowers inflammation over time, which is thought to contribute to depression. These positive findings suggest that supervised exercise could be a promising treatment for depression in people living with HIV. ^{1 2 3 6 7}

Who Is on the Research Team?

Sarah Lofgren, PhD

Principal Investigator

University of Minnesota

Ryan Mays, PhD

Principal Investigator

University of Minnesota

Anita Arinda, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults aged 18-45 with HIV, who are not currently in a formal exercise program or doing manual labor. They must be receiving HIV therapy and have their virus under control (less than 400 copies/mL). Participants should also have mild to moderate depression but not severe enough to score over 20 on the PHQ9 scale.

Inclusion Criteria

You are not currently doing regular exercise or physically demanding work like construction or delivery.

You are currently receiving care at the Mildmay HIV clinic.

You have HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a supervised treadmill exercise intervention to evaluate its efficacy in reducing inflammation and depression in people with HIV

8 weeks

Regular visits for supervised exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after the exercise intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Supervised Treadmill Intervention

Trial Overview The STRIDE Pilot Study is testing whether supervised treadmill exercises can help reduce inflammation and alleviate symptoms of depression in people living with HIV. The study will provide upfront advice on walking as part of the intervention.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

participants randomized to intervention group

Group II: control Placebo Group 1 Intervention

participants randomized to control group

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

A 16-week combined exercise training program significantly increased muscle strength by 25% and improved aerobic capacity by 20% in people living with HIV, based on a study of 23 participants.

Participants in the training group also experienced a notable reduction in depression rates, going from 7 individuals with varying levels of depression to just 1 after the program, alongside improvements in their overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Combined Exercise Training Program on Health Indicators and Quality of Life of People Living with HIV: A Randomized Clinical Trial. Oliveira, VHF., Rosa, FT., Santos, JC., et al.[2020]

A 12-week community-based exercise program significantly reduced depression symptoms in people living with HIV (PLWH), with 52 participants showing improved scores on the Beck Depression Inventory (BDI).

Participants who attended at least one exercise session per week experienced a fourfold greater improvement in their depression symptoms compared to those who were less compliant, highlighting the importance of regular exercise in managing depression among PLWH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a community-based exercise program on depression symptoms among people living with HIV. Sousa, CV., Lewis, JE., Simoes, HG., et al.[2021]

In a 24-week exercise training program involving 25 individuals with HIV, only 6 completed the program, but all showed significant improvements in cardiovascular fitness, including increased VO2max and decreased heart rate during submaximal exercise.

The study suggests that while exercise training is feasible and beneficial for some HIV-infected individuals, mental health factors like depression and anxiety may impact CD4 counts, indicating a need for holistic approaches in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised exercise training improves cardiopulmonary fitness in HIV-infected persons. MacArthur, RD., Levine, SD., Birk, TJ.[2022]

In a study of 22 HIV-positive patients participating in a 10-week exercise program, perceived physical, functional, and psychological well-being significantly influenced adherence to the exercise regimen, explaining 55.7% of attendance variance.

No differences in adherence were found based on age, CD4 count, or fitness level, suggesting that psychological factors may be more critical in determining whether patients stick to exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV Patient Characteristics that Affect Adherence to Exercise Programmes: An Observational Study. Petróczi, A., Hawkins, K., Jones, G., et al.[2021]

Exercise significantly reduces symptoms of depression and anxiety in people living with HIV, with large effect sizes of -0.84 for depression and -1.23 for anxiety based on a meta-analysis of 10 studies involving 479 participants.

Aerobic exercise, a frequency of at least three sessions per week, and professionally supervised programs were particularly effective in reducing depression symptoms, indicating that the type and structure of exercise play a crucial role in its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on depression and anxiety in persons living with HIV: A meta-analysis. Heissel, A., Zech, P., Rapp, MA., et al.[2020]

People living with HIV (PLWH) often experience increased risks of cardiovascular disease (CVD) due to side effects from antiretroviral therapy, such as dyslipidemia and abnormal body fat distribution.

Engaging in physical activity, especially higher intensity aerobic and resistance exercises, can improve cardiovascular health and metabolic markers in PLWH, countering some of the negative effects of their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise to improve cardiovascular health for adults living with HIV. Ozemek, C., Erlandson, KM., Jankowski, CM.[2020]

A 12-week supervised aerobic exercise program significantly reduced self-reported depressive symptoms in 60 HIV-infected adults compared to control participants.

The study found strong correlations between different scales measuring depressive symptoms, supporting the validity of these assessment tools in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise training for depressive symptom management in adults living with HIV infection. Neidig, JL., Smith, BA., Brashers, DE.[2022]

Exercise has a short-term effect on reducing depression scores in adults with clinical depression, with a pooled standardized mean difference of -0.40, indicating a moderate improvement compared to non-exercise groups.

However, there is little evidence to support long-term benefits of exercise for depression, as follow-up studies showed no significant lasting effects beyond the intervention period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise in clinically depressed adults: systematic review and meta-analysis of randomized controlled trials. Krogh, J., Nordentoft, M., Sterne, JA., et al.[2023]

In a study of 165 adults with unipolar depression, strength training significantly improved work capacity, reducing absenteeism by 12.1% compared to relaxation training, while aerobic training showed no significant effect on work absence.

Despite improvements in physical strength and aerobic capacity, neither strength nor aerobic training led to significant reductions in depression severity as measured by the Hamilton Rating Scale for Depression (HAM-D(17)) at 4 or 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression. Krogh, J., Saltin, B., Gluud, C., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06149624

Supervised Treadmill Intervention to Reduce Inflammation ... ... efficacy of exercise as an intervention for depression in people with HIV. Official Title. Supervised Treadmill Intervention to Reduce Inflammation and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9109396/

Impact of exercise training on symptoms of depression ... For evidence of the effects of exercise training on depression, physical activity level and social participation in HIV conditions. Data Availability Statement.

3. bjsm.bmj.com bjsm.bmj.com/content/57/18/1203

Effectiveness of physical activity interventions for improving ... Findings suggest that PA interventions are effective in improving symptoms of depression and anxiety.

4. withpower.com withpower.com/trial/phase-hiv-2024-171d1

Supervised Exercise for Depression in HIV A 12-week supervised aerobic exercise program significantly reduced self-reported depressive symptoms in 60 HIV-infected adults compared to control participants ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10579187/

Effectiveness of physical activity interventions for improving ... Physical activity had medium effects on depression (median effect size=−0.43, IQR=−0.66 to –0.27), anxiety (median effect size=−0.42, IQR=−0.66 to –0.26) and ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06149624/supervised-treadmill-intervention-to-reduce-inflammation-and-depression-through-exercise-in-hiv-the-stride-pilot-study

The STRIDE Pilot Study | Clinical Research Trial Listing Supervised Treadmill Intervention to Reduce Inflammation and Depression Through Exercise in HIV: The STRIDE Pilot Study. Last updated: May 27 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4845358/

Effectiveness of aerobic exercise for adults living with HIV Our aim was to examine the safety and effectiveness of aerobic exercise interventions on immunological, virological, cardiorespiratory, strength, weight, body ...