Exercise for Sleep and Inflammation in HIV

(REST Trial)

Recruiting at 1 trial location

Overseen By Christine Horvat Davey, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Christine Horvat Davey

Must be taking: Antiretrovirals

Disqualifiers: Uncontrolled hypertension, Heart disease, Pulmonary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this randomized clinical trial is to characterize the effects of two exercise interventions, high-intensity interval training (HIIT) and continuous moderate-intensity exercise (CME), on sleep and inflammation in older people living with HIV (PWH). This study is a sub-study associated with The High Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults with HIV (HEALTH-HIV; NCT04550676). The investigators propose the following aims: Aim 1. Compare the effectiveness of HIIT and CME exercise interventions on sleep in older PWH. Aim 2. Quantify inflammation markers associated with sleep quality (self-report surveys) in older PWH at baseline, between (week 8) and after exercise interventions (HIIT and CME) (week 16). The investigators hypothesize HIIT will lead to greater improvement in sleep quality (duration and quality) compared to CME and older PWH who experience poor sleep quality and the CME intervention will have increased inflammation markers compared to older PWH who experience better sleep quality and the HIIT intervention. The intervention is being delivered by research personnel at the University of Washington associated with the HEALTH-HIV study (NCT04550676). Data for this study will only be collected at the University of Washington site of the HEALTH-HIV study.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on a current, modern antiretroviral therapy (ART) to participate.

What data supports the effectiveness of the treatment CME, Continuous Moderate-Intensity Exercise, and HIIT, High-Intensity Interval Training, for improving sleep and reducing inflammation in people with HIV?

Research shows that both moderate and high-intensity exercise can improve inflammation markers and exercise capacity in people living with HIV. These improvements suggest that exercise may help manage inflammation and potentially improve sleep quality in this population. ^{1 2 3 4 5}

Is exercise safe for people living with HIV?

Exercise, including moderate and high-intensity training, has been studied in people living with HIV and is generally considered safe. Studies show improvements in fitness and immune markers without significant adverse effects, suggesting it is a safe option for this population. ^{3 4 6 7 8}

How does the exercise treatment for sleep and inflammation in HIV differ from other treatments?

This treatment is unique because it uses exercise, specifically Continuous Moderate-Intensity Exercise (CME) and High-Intensity Interval Training (HIIT), to reduce inflammation and improve sleep in people with HIV. Unlike traditional drug treatments, this approach focuses on physical activity to enhance immune function and overall health. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for people over 50 living with HIV who have poor sleep quality, are on modern antiretroviral therapy, and lead a sedentary lifestyle. They must not have uncontrolled high blood pressure, serious heart conditions without clearance, or severe pulmonary disease requiring oxygen.

Inclusion Criteria

I am HIV positive.

Willing to engage in a supervised exercise program 3 times/week for 16 weeks

I am on a modern HIV treatment regimen.

Exclusion Criteria

My blood pressure is not higher than 150/90 mmHg.

I do not have unstable heart disease or serious heart rhythm problems.

I need extra oxygen to breathe, even when resting or moving.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either high-intensity interval training (HIIT) or continuous moderate-intensity exercise (CME) to assess effects on sleep and inflammation markers

16 weeks

Regular visits for exercise sessions and assessments

Follow-up

Participants are monitored for changes in sleep quality and inflammation markers after the exercise interventions

4 weeks

Treatment Details

Interventions

• CME
• HIIT

Trial Overview The study tests how two types of exercise—high-intensity interval training (HIIT) and continuous moderate-intensity exercise (CME)—affect sleep and inflammation in older adults with HIV. Participants will be randomly assigned to one of the exercise programs for 16 weeks.

Participant Groups

Group I: High intensity interval training Experimental Treatment 1 Intervention

Group II: Continuous moderate intensity exercise Active Control 1 Intervention

Who Is Running the Clinical Trial?

Christine Horvat Davey

Lead Sponsor

Trials

1

Recruited

50+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

University of Colorado - Anschutz Medical Campus

Collaborator

Trials

9

Recruited

1,700+

Findings from Research

In a study involving 69 participants (32 with HIV and 37 controls) over 24 weeks, both moderate and high-intensity exercise resulted in similar reductions in inflammation markers, indicating that exercise intensity may not significantly affect inflammation in people with HIV compared to controls.

High-intensity exercise led to notable increases in the inflammation marker sCD14 for both groups, while controls also showed significant increases in IL-10, suggesting that further research is needed to understand these responses, especially in people with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Moderate or High-Intensity Combined Exercise on Systemic Inflammation Among Older Persons With and Without HIV. Erlandson, KM., Wilson, MP., MaWhinney, S., et al.[2022]

A 12-week pilot study involving 49 HIV-infected individuals showed that moderate-intensity exercise, including brisk walking and circuit training, significantly improved body mass index, waist and hip circumference, and total cholesterol levels.

Participants also experienced notable reductions in inflammatory markers such as hsCRP, IL-6, and D-dimer, indicating that regular exercise can positively impact both metabolic health and inflammation in people living with chronic HIV infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of brisk walking in sedentary combination antiretroviral treatement (cART)- treated patients: benefit on soluble and cell inflammatory markers. Bonato, M., Galli, L., Passeri, L., et al.[2022]

In a 16-week clinical trial with 49 participants living with HIV on antiretroviral therapy, concurrent training (a mix of aerobic and resistance exercises) significantly reduced levels of pro-inflammatory cytokines IL-5, IL-8, and IL-10 compared to a control group engaged in recreational activities.

The results suggest that short-term exercise can have beneficial effects on inflammation in HIV-infected individuals, potentially improving their overall health while on ART.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise improves cytokine profile in HIV-infected people: A randomized clinical trial. Pedro, RE., Candido, N., Guariglia, DA., et al.[2018]

A 12-week exercise program significantly improved exercise capacity in HIV-1 positive individuals, with the high intensity group showing a greater increase compared to the moderate intensity group.

Despite the improvements in exercise capacity, there were no significant changes in immunologic markers, body measurements, or depression scores, suggesting that while exercise enhances physical fitness, it may not directly affect immune function or mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate and high intensity exercise training in HIV-1 seropositive individuals: a randomized trial. Terry, L., Sprinz, E., Ribeiro, JP.[2022]

A 6-week aerobic exercise program significantly improved aerobic fitness and quality of life in 34 HIV+ patients, with both moderate and heavy exercise groups showing benefits compared to a control group.

While immune indices showed little change, the moderate exercise group did see a significant increase in Candida skin test responses, indicating some immune function improvement, and no opportunistic infections occurred during the study, highlighting the safety of exercise in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise training on aerobic fitness, immune indices, and quality of life in HIV+ patients. Stringer, WW., Berezovskaya, M., O'Brien, WA., et al.[2022]

A pilot study involving 26 older adults with HIV showed that high-intensity interval training (HIIT) combined with resistance training significantly improved cardiorespiratory fitness, with a 17.1% increase in VO2peak after HIIT.

Both HIIT and continuous high-intensity aerobic exercise (AEX) led to improvements in exercise endurance and strength, indicating that structured exercise programs can effectively combat the effects of advanced aging in adults with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effects of high-intensity interval training in older adults living with HIV. Briggs, BC., Ryan, AS., Sorkin, JD., et al.[2021]

Combined exercise (CE) in individuals living with HIV/AIDS (ILWHA) significantly reduced cortisol levels and increased testosterone and immunoglobulin A levels, indicating potential benefits for hormonal balance and immune function.

The study involved a controlled exercise regimen with saliva samples collected at various intervals, showing that while CE positively influenced certain hormonal responses, it did not significantly alter pro-inflammatory or anti-inflammatory cytokine levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Exercise Modulates Cortisol, Testosterone, and Immunoglobulin A Levels in Individuals Living With HIV/AIDS. Melo, BP., Guariglia, DA., Pedro, RE., et al.[2020]

In a study of 41 people living with HIV, a 12-week daily undulating periodization (DUP) training program significantly improved muscle strength, aerobic capacity, and TCD4+ cell counts compared to nonperiodized training (NPT).

DUP training led to greater gains in muscle strength and fat-free mass, and it was the only method that resulted in an increase in TCD4+ cells, indicating a positive impact on immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Undulating Periodization Is More Effective Than Nonperiodized Training on Maximal Strength, Aerobic Capacity, and TCD4+ Cell Count in People Living With HIV. Soares, VL., Soares, WF., Zanetti, HR., et al.[2023]

References

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

The Impact of Moderate or High-Intensity Combined Exercise on Systemic Inflammation Among Older Persons With and Without HIV. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A pilot study of brisk walking in sedentary combination antiretroviral treatement (cART)- treated patients: benefit on soluble and cell inflammatory markers. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Exercise improves cytokine profile in HIV-infected people: A randomized clinical trial. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Moderate and high intensity exercise training in HIV-1 seropositive individuals: a randomized trial. [2022]

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

The effect of exercise training on aerobic fitness, immune indices, and quality of life in HIV+ patients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Feasibility and effects of high-intensity interval training in older adults living with HIV. [2021]

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

Combined Exercise Modulates Cortisol, Testosterone, and Immunoglobulin A Levels in Individuals Living With HIV/AIDS. [2020]

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

Daily Undulating Periodization Is More Effective Than Nonperiodized Training on Maximal Strength, Aerobic Capacity, and TCD4+ Cell Count in People Living With HIV. [2023]