High-Intensity Exercise for Older Adults with HIV

(HEALTH Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether high-intensity interval training (HIIT) can improve physical function and reduce fatigue in older adults with HIV more effectively than continuous moderate exercise (CME). It also examines whether coaching can help participants maintain long-term exercise habits. The trial seeks participants who are 50 years or older, have had HIV for at least a year, experience fatigue, and lead a sedentary lifestyle. Participants must commit to a 16-week exercise program, three times a week. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance exercise programs for older adults with HIV.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that high-intensity interval training (HIIT) can be safe and effective for older adults with HIV. Studies have examined the feasibility of HIIT and found that this group can manage it well. For instance, one study discovered that HIIT improved heart and lung fitness and endurance in older adults with HIV, with results similar to those from regular moderate exercise.

These studies have reported no major serious side effects from HIIT, suggesting that it could be a safe way to boost physical health in older adults with HIV. However, as with any exercise program, participants should start slowly and maintain communication with their healthcare providers throughout. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring high-intensity exercise for older adults with HIV because it offers a novel approach to managing the condition beyond traditional medication. Unlike standard antiretroviral therapies that focus on controlling the virus, high-intensity interval training (HIIT) could improve cardiovascular fitness, muscle strength, and overall quality of life. Meanwhile, continuous moderate-intensity exercise (CME) provides a more sustainable, less intense option that may still yield significant health benefits. This trial aims to uncover how these exercise regimens can complement existing treatments, potentially leading to a more holistic approach to HIV management in older populations.

What evidence suggests that this trial's treatments could be effective for older adults with HIV?

Research has shown that high-intensity interval training (HIIT), one of the treatments studied in this trial, can significantly boost fitness levels in older adults living with HIV. One study found a 17% increase in VO2peak, which measures how efficiently the body uses oxygen, in participants with an average age of 63, indicating improved heart and lung function. Another study found that HIIT is feasible and can enhance overall health, including brain function, in older people with HIV. These findings suggest that HIIT might reduce tiredness and improve physical abilities in this group. This trial will also evaluate continuous moderate-intensity exercise (CME) as another treatment option to compare its effects on fitness and health outcomes in older adults with HIV. ^{1 2 4 6 7}

Who Is on the Research Team?

Kristine Erlandson, MD, MS

Principal Investigator

University of Colorado, Denver

Allison Webel, PhD, RN

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 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 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

What Are the Treatments Tested in This Trial?

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.

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?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8212165/

Feasibility and effects of high-intensity interval training in ...

In comparison, we found HIIT increased VO2peak 17% in adults with HIV who were on average 10 years older (mean age 63 years), many with age- ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06888596

Feasibility of HIIT in Older Adults with HIV and Hypertension

The focus is on collecting data on the efficacy and feasibility of short-term high-intensity interval training among older people with HIV (PWH) ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12487839/

Examining High-Intensity Exercise on Cognitive and Vascular ...

Older people living with HIV (PLWH), particularly in the Deep South, have poorer health outcomes (cognitive impairment) than seronegative adults ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1728869X2500036X

Feasibility and effects of high-intensity interval training in ...

This study provides preliminary evidence on the feasibility and effect of HIIT for older adults with MMD. Both HIIT and MICT-BDJ improved depressive symptoms ...

5.

mdpi.com

mdpi.com/1660-4601/19/14/8439

Effects of Physical Activity Interventions on Health ...

These findings suggest that physical activity interventions for people living with HIV aged ≥50 years are effective for the improvement of walking capacity.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41026763/

Examining High-Intensity Exercise on Cognitive and ...

Older people living with HIV (PLWH), particularly in the Deep South, have poorer health outcomes (cognitive impairment) than seronegative adults ...

7.

nature.com

nature.com/articles/s41598-025-91833-z

Acute effects of high-intensity interval training and ...

Post-hoc tests confirmed that HIIT and MICT effectively diminished reaction time for Switching after exercises and at 45 min post-exercise.