High-Intensity Exercise for Older Adults with HIV

(HEALTH Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: HIV antiretrovirals

Must not be taking: Older mitochondrial toxic drugs

Disqualifiers: Anemia, Mitochondrial disease, Uncontrolled hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

118 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-site, randomized, single-blind (researchers), active treatment concurrent control trial with individuals aged 50-80 living with HIV who experience fatigue and live a sedentary lifestyle. The overall goals of this proposal are to determine whether high-intensity interval training (HIIT) can overcome physical function impairments and increased fatigue (Aim 1) and impairments in mitochondrial bioenergetics of older people with HIV (PWH) to a greater extent than continuous moderate-intensity exercise (CME) (Aim 2). The investigators further seek to determine whether a biobehavioral coaching intervention following either HIIT or CME can promote long-term adherence to physical activity (Aim 3), a crucial component of the sustainability of the intervention. This study will enroll 100 participants in Aurora, Colorado and Seattle, Washington. Data collection will occur at each visit, with baseline data collected at the initial visit. A 3-month follow-up will be conducted over the phone from the date of the final visit. The initial enrollment goal of 100 was increased to 120 in 2023 to facilitate a larger number of participants with key secondary outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on sex hormone therapy or other hormone replacement, you must have been on a stable dose for more than 3 months. Also, if you are undergoing a muscle biopsy, you may need to stop taking certain medications like aspirin for 7 days before the procedure.

What data supports the effectiveness of the treatment High-Intensity Exercise for Older Adults with HIV?

Research shows that high-intensity interval training (HIIT) can significantly improve cardiorespiratory fitness in older adults with HIV, with a 17.1% increase in VO2peak, which measures how well the body uses oxygen during exercise. This suggests that HIIT may help counteract the accelerated aging process seen in people with HIV. ^{1 2 3 4 5}

Is high-intensity exercise safe for older adults with HIV?

Research shows that high-intensity exercise, including high-intensity interval training (HIIT), is generally safe for older adults with HIV. Studies have found improvements in fitness and endurance without significant safety concerns. ^{2 3 4 6 7}

How does high-intensity exercise differ from other treatments for older adults with HIV?

High-intensity exercise, specifically high-intensity interval training (HIIT), is unique because it focuses on improving physical function and reducing fatigue in older adults with HIV, which is not typically addressed by standard treatments. This approach also includes biobehavioral coaching and mobile health text messaging to encourage long-term adherence to physical activity, making it a comprehensive lifestyle intervention rather than just a medical treatment. ^{2 4 6 8 9}

Research Team

Kristine Erlandson, MD, MS

Principal Investigator

University of Colorado, Denver

Allison Webel, PhD, RN

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for adults aged 50-80 with HIV who are sedentary, experience fatigue, and have been on stable antiretroviral therapy with a controlled viral load. They must be willing to commit to a 16-week exercise program and have no major health issues like severe heart disease or uncontrolled diabetes that could interfere with safe participation.

Inclusion Criteria

Sedentary lifestyle, defined by self-reported physical activity that breaks a sweat <3 days/week, with no regular resistance exercise for 3 months preceding study

I often feel very tired.

I am 50 years old or older.

Exclusion Criteria

I have been on stable hormone replacement therapy for more than 3 months.

I have been on stable doses of sex hormone therapy for more than 3 months.

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

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 physical function and fatigue

16 weeks

Regular visits for data collection

Follow-up

Participants are monitored for adherence to physical activity and long-term effects of the intervention

3 months

Conducted over the phone

Treatment Details

Interventions

• CME
• HIIT

Trial Overview The study compares high-intensity interval training (HIIT) against continuous moderate-intensity exercise (CME) in improving physical function, reducing fatigue, and enhancing mitochondrial bioenergetics in older adults living with HIV. It also tests if biobehavioral coaching can help maintain long-term physical activity habits after the intervention.

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?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Findings from Research

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]

A 15-week home-based aerobic exercise program for 99 HIV-infected adults showed no significant improvements in physical endurance or overall health-related quality of life, except for a notable increase in the Overall Health subscale of the Medical Outcomes Study-HIV Health Survey.

The exercise intervention was safe for participants, and while it maintained physical endurance levels compared to a decline in the control group, longer or more progressive exercise protocols may be needed to achieve more substantial health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a home-based exercise intervention for HIV-infected adults: a randomized trial. Baigis, J., Korniewicz, DM., Chase, G., et al.[2022]

The HEALTH study aims to compare the effects of high-intensity interval training (HIIT) versus continuous moderate exercise (CME) on physical function, fatigue, and mitochondrial health in 100 older adults living with HIV over a total of 28 weeks.

The study also includes a biobehavioral coaching and mobile health text messaging intervention to encourage long-term adherence to physical activity, which could lead to tailored exercise recommendations for aging individuals with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The High-Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults With HIV (HEALTH): A Research Protocol. Oliveira, VHF., Erlandson, KM., Cook, PF., et al.[2023]

A low-volume high-intensity interval training (LV-HIIT) program improved peak workload and time to peak exercise in both HIV+ and HIV- Hispanic women, indicating its effectiveness in enhancing certain aspects of physical fitness.

However, only the HIV- group showed a significant increase in cardiorespiratory fitness (CRF), suggesting that while LV-HIIT can benefit overall exercise capacity, it may not be as effective for improving CRF in individuals living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Effects of Low-Volume High-Intensity Interval Training in Hispanic HIV+ Women: A Nonrandomized Study. Ramírez-Marrero, FA., Pérez-Frontera, S., Amalbert-Birriel, MA., et al.[2021]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of aerobic exercise for adults living with HIV: systematic review and meta-analysis using the Cochrane Collaboration protocol. [2022]

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

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

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

Effectiveness of a home-based exercise intervention for HIV-infected adults: a randomized trial. [2022]

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

The High-Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults With HIV (HEALTH): A Research Protocol. [2023]

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

Effects of progressive resistive exercise in adults living with HIV/AIDS: systematic review and meta-analysis of randomized trials. [2022]

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

Brief Report: Effects of Low-Volume High-Intensity Interval Training in Hispanic HIV+ Women: A Nonrandomized Study. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

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

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

Development of evidence-based exercise recommendations for older HIV-infected patients. [2017]

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

A cross-sectional description of age and gender differences in exercise patterns in adults living with HIV. [2021]