Exercise for Sleep and Inflammation in HIV

(REST Trial)

Recruiting at 2 trial locations

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

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two types of exercise—high-intensity interval training (HIIT) and continuous moderate-intensity exercise (CME)—affect sleep and inflammation in older people living with HIV. Researchers aim to determine which exercise more effectively improves sleep quality and reduces inflammation. It suits individuals aged 50 or older who have HIV, lead a mostly inactive lifestyle, are on antiretroviral therapy, and experience sleep difficulties. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding how exercise can enhance health outcomes in their community.

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 prior data suggests that these exercise interventions are safe for older people living with HIV?

Research has shown that both high-intensity interval training (HIIT) and continuous moderate-intensity exercise (CME) are safe for older people living with HIV. Studies highlight that HIIT not only boosts health but is also well-received by participants. For instance, HIIT can lower cholesterol and improve insulin handling without causing serious side effects.

Similarly, CME is safe for people with HIV. A review found that moderate exercise, whether done at home or in the community, does not pose significant health risks. Instead, it can improve body shape and overall quality of life.

In summary, both types of exercise are safe for older adults with HIV, with HIIT possibly offering more health benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise interventions being studied for sleep and inflammation in people with HIV because they offer a non-pharmacological approach to managing these issues. High-intensity interval training (HIIT) and continuous moderate-intensity exercise (CME) are being explored for their potential to improve sleep quality and reduce inflammation without the side effects often associated with medications. Unlike conventional treatments that might involve drugs targeting inflammation or sleep aids, these exercise regimens aim to enhance overall health and well-being through physical activity. The unique aspect of this study is its focus on exercise as a therapeutic tool, which could provide a more holistic and sustainable option for managing common complications in HIV.

What evidence suggests that this trial's exercise interventions could be effective for improving sleep and reducing inflammation in older adults with HIV?

This trial will compare high-intensity interval training (HIIT) with continuous moderate-intensity exercise (CME) for their effects on sleep and inflammation in people with HIV. Research has shown that HIIT can improve fitness and reduce inflammation, with one study finding significant reductions in key inflammation markers. Another study demonstrated that HIIT effectively boosts heart and lung fitness, which often declines with age in this group. For CME, evidence suggests it can enhance aerobic fitness and has been linked to lower levels of inflammation markers like CRP and IL-6. Both exercise types show promise for improving sleep and reducing inflammation in older adults with HIV. ^{2 3 4 6 7}

Who Is on the Research Team?

Christine Horvat Davey, PhD, RN

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04946994

Relationship of Exercise, Sleep, and Inflammation Markers ... The purpose of this randomized clinical trial is to characterize the effects of two exercise interventions, high-intensity interval training (HIIT) and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4433614/

Association of Markers of Inflammation with Sleep and ... Moderate intensity exercise training reverses functional aerobic impairment in HIV-infected individuals. AIDS Care. 2008 Oct;20(9):1066–1074. doi: 10.1080 ...

3. withpower.com withpower.com/trial/phase-inflammation-7-2021-fafb5

Exercise for Sleep and Inflammation in HIV (REST Trial) Research Study Groups: This trial has the following groups: Group 1: High intensity interval training; Group 2: Continuous moderate intensity exercise.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0091743524002998

A systematic review and meta-analysis evaluating the ... This review aimed to synthesize evidence on the effectiveness of minimally supervised HCE for physical activity (PA), adiposity, quality of life (QoL),

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3767244/

Moderate-Intensity Exercise Improves Body Composition ... Studies have repeatedly shown the benefits of aerobic exercise against inflammation by decreasing CRP, IL-6, TNF-α, among other proinflammatory markers [45–47].

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8613312/

The High-Intensity Exercise Study to Attenuate Limitations ... High-intensity interval training is demonstrated to be safe and to have superior efficacy in improving health outcomes compared to continuous moderate exercise ...

7. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-17700-0

Impact of exercise training and diet therapy on the physical ... This study aimed to analyze the effects of exercise and dietary intervention on physical fitness, quality of life and immune response in PLWHA.