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

22 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Supervised Treadmill Intervention, Exercise Therapy, Physical Activity Intervention, Treadmill Exercise for depression in HIV?

Research shows that aerobic exercise, like treadmill workouts, can help reduce depressive symptoms in people living with HIV. A study found that HIV-infected adults who participated in a supervised aerobic exercise program reported fewer symptoms of depression compared to those who did not exercise. ^{1 2 3 4 5}

Is supervised exercise safe for people living with HIV?

Supervised exercise, including aerobic and resistance training, has been shown to be safe for people living with HIV. Studies indicate that exercise does not harm immune function and can improve fitness, muscle strength, and quality of life without adverse effects. ^{1 2 6 7 8}

How does the Supervised Treadmill Intervention treatment for depression in HIV differ from other treatments?

The Supervised Treadmill Intervention is unique because it uses structured exercise, specifically treadmill walking, to help reduce depression in people living with HIV. Unlike medications, this treatment focuses on physical activity, which can improve mood and overall well-being without the side effects associated with drugs. ^{1 2 5 7 9}

What is the purpose of this trial?

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.

Research Team

Sarah Lofgren, PhD

Principal Investigator

University of Minnesota

Anita Arinda, PhD

Principal Investigator

University of Minnesota

Ryan Mays, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Aerobic exercise training for depressive symptom management in adults living with HIV infection. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Supervised exercise training improves cardiopulmonary fitness in HIV-infected persons. [2022]

3. United States 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of exercise in clinically depressed adults: systematic review and meta-analysis of randomized controlled trials. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effects of exercise on depression and anxiety in persons living with HIV: A meta-analysis. [2020]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

HIV Patient Characteristics that Affect Adherence to Exercise Programmes: An Observational Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Physical activity and exercise to improve cardiovascular health for adults living with HIV. [2020]

8. United States 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. [2020]

9. England pubmed.ncbi.nlm.nih.gov

The effectiveness of a community-based exercise program on depression symptoms among people living with HIV. [2021]