High-Intensity Exercise for Cognitive Impairment with HIV

Overseen By Raymond Jones, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: HIV ART

Disqualifiers: Mitochondrial disease, Substance abuse, Hypertension, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

60 Participants Needed

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 enhance thinking skills and blood vessel health in individuals with HIV who experience memory and concentration issues. It compares HIIT to regular, moderate exercise to determine which is more effective. The trial also examines barriers to exercise and participants' perceptions of the exercise routines. Suitable candidates have HIV, are over 50, and lead relatively inactive lifestyles. As an unphased trial, this study provides a unique opportunity to contribute to understanding how exercise can benefit cognitive and vascular health in HIV patients.

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 have been on prescribed HIV ART (antiretroviral therapy) for at least 12 months and not be using older drugs with known mitochondrial toxicity.

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

Research has shown that high-intensity interval training (HIIT) is generally safe for people living with HIV. One study found that HIIT improved fitness levels without causing harmful effects. Another study reported a low risk of serious issues, with only two nonfatal incidents occurring in over 46,000 hours of exercise. These findings suggest that HIIT is well-tolerated, even for those with health challenges.

While specific safety data for regular moderate exercise is not available from the sources, moderate exercise is often recommended for its health benefits and low risk of harm. Both types of exercise appear to be safe options for improving health in older adults with HIV. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise techniques for cognitive impairment in HIV because they offer a unique, non-pharmacological approach to treatment. Unlike standard care options that typically involve medication to manage symptoms, these exercise regimens—Continuous Moderate Exercise and High-Intensity Interval Training—focus on improving brain health through physical activity. High-Intensity Interval Training, in particular, is thought to enhance cognitive function by boosting blood flow and stimulating brain plasticity more effectively than consistent moderate exercise. These methods could provide a dynamic and accessible alternative for managing cognitive issues, potentially leading to improved quality of life without the side effects associated with medication.

What evidence suggests that this trial's exercise interventions could be effective for cognitive impairment with HIV?

Research has shown that high-intensity interval training (HIIT), one of the treatments in this trial, can enhance thinking and memory skills. In a small study with older adults living with HIV, HIIT combined with strength exercises significantly boosted their mental abilities. Another study found that even short-term HIIT improved decision-making and memory. These findings suggest that the intense bursts of exercise in HIIT might aid mental challenges. While regular moderate exercise, another treatment arm in this trial, is beneficial, HIIT appears to offer greater advantages for improving mental performance in people living with HIV. ^{1 5 6 7 8}

Who Is on the Research Team?

Raymond Jones, Ph.D.

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults over 50 living with HIV who have cognitive challenges and a sedentary lifestyle. They must be on HIV treatment without old drugs known to harm mitochondria, speak English, and not engage in moderate exercise more than 150 minutes per week. Exclusions include severe heart disease, uncontrolled diabetes or hypertension, kidney or mitochondrial diseases, active substance abuse, orthopedic limitations to exercise, other trials' participation, or needing oxygen for lung issues.

Inclusion Criteria

I have been on HIV treatment for over a year without using drugs known to harm mitochondria.

Able to speak, read, and write in English

I am 50 years old or older.

Exclusion Criteria

I have chronic kidney disease.

I have been diagnosed with a mitochondrial disease.

My diabetes is not well-managed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline data collection including vascular function and cognitive assessments

1 week

1 visit (in-person)

Treatment

Participants undergo 16 weeks of structured high-intensity interval training (HIIT) or continuous moderate exercise

16 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 3-month post-intervention assessments

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Moderate Exercise
• High-Intensity Interval Training

Trial Overview

The study compares two types of exercises: high-intensity interval training (HIIT) versus continuous moderate exercise to see which better improves blood vessel health and brain function in older adults with HIV after 12 weeks. It also explores participants' barriers to exercising and their views on the interventions.

How Is the Trial Designed?

Group I: High-Intensity Interval Training Experimental Treatment 1 Intervention

Group II: Continuous Moderate Exercise Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

High-Intensity Interval Training in a circuit program (HIICT) was found to significantly improve upper limb strength and body mass index compared to moderate-intensity continuous training (MICT) and a non-exercise control group in a study of 54 middle-aged and older women over 18 weeks.

Both HIICT and MICT were effective in enhancing lower limb strength, cardiorespiratory fitness, and balance compared to the control group, indicating that while HIICT has specific advantages, both training types are beneficial for overall functional ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Circuit Training Versus Moderate-Intensity Continuous Training on Functional Ability and Body Mass Index in Middle-Aged and Older Women: A Randomized Controlled Trial. Ballesta-García, I., Martínez-González-Moro, I., Rubio-Arias, JÁ., et al.[2020]

A 12-week exercise program combining high-intensity interval training and resistance exercises improved physical performance in people with HIV, with effect sizes ranging from 0.2 to 1.5.

However, the program did not lead to significant improvements in cognitive ability, as measured by the Brief Cognitive Ability Measure (B-CAM), indicating that while exercise benefits physical health, its effects on cognitive function in this population remain unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and potential benefits of a structured exercise program on cognitive performance in HIV. Kaur, N., Aubertin-Leheudre, M., Fellows, LK., et al.[2022]

High-intensity interval training (HIIT) is an efficient exercise strategy that can provide similar or even superior health benefits compared to traditional aerobic exercise, making it a time-saving option for improving overall health.

Recent studies suggest that HIIT may be particularly effective in enhancing cognitive function and could serve as a rehabilitation therapy for cognitive impairments related to obesity, diabetes, stroke, and dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research advances on high-intensity interval training and cognitive function]. Hu, JY., Cai, M., Shang, QH., et al.[2021]

Moderate aerobic exercise training (3 times per week for 6 to 12 weeks) significantly improves aerobic capacity in HIV-positive individuals without harming their immune system.

The exercise also leads to small improvements in immune function and quality of life, making it a safe and effective therapy for HIV-positive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV and aerobic exercise. Current recommendations. Stringer, WW.[2018]

A 16-week concurrent training program significantly improved cardiorespiratory fitness and endurance in people living with HIV/AIDS on antiretroviral therapy, as evidenced by increased peak oxygen uptake (V[Combining Dot Above]O2peak) and peak speed (Vpeak).

While resting heart rate variability (HRVrest) indices did not show significant changes, there were indications of a possibly positive effect on high frequency (HF) and a likely positive effect on mean R-R intervals, suggesting potential benefits for heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 16 Weeks of Concurrent Training on Resting Heart Rate Variability and Cardiorespiratory Fitness in People Living With HIV/AIDS Using Antiretroviral Therapy: A Randomized Clinical Trial. Pedro, RE., Guariglia, DA., Okuno, NM., et al.[2018]

The BRAIN Training Trial is investigating the effects of high-intensity aerobic interval training (HIIT) and high-intensity power training (POWER) on cognitive function in 160 older adults (≥ 60 years) with mild cognitive impairment (MCI) over 12 months, aiming to provide clearer insights into effective exercise interventions for cognitive health.

The primary outcome will be assessed through a cognitive composite score at baseline, 6 months, and 12 months, which will help determine if these high-intensity exercise programs can significantly improve cognitive performance compared to a sham exercise control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for the BRAIN Training Trial: a randomised controlled trial of Balance, Resistance, And INterval training on cognitive function in older adults with mild cognitive impairment. Valenzuela, T., Coombes, JS., Liu-Ambrose, T., et al.[2023]

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 13-week study involving 54 physically inactive adults showed that a personalized exercise program combining moderate-intensity continuous training (MICT) and high-intensity interval training (HIIT) significantly improved cardiovascular fitness (VO2max) and metabolic health (MetS z-score) compared to a standardized MICT program and a control group.

All participants in the personalized MICT + HIIT group experienced positive changes in their fitness and metabolic health, indicating that tailored exercise prescriptions can lead to more effective and consistent health benefits than standard approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Moderate-Intensity Exercise Training Combined with High-Intensity Interval Training Enhances Training Responsiveness. Byrd, BR., Keith, J., Keeling, SM., et al.[2020]

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]

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]

In a study of 21 patients with myocardial infarction, both home-based high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) improved functional capacity and health outcomes over 12 weeks.

HIIT was found to be more effective than MICT in enhancing pulmonary function and lower extremity muscle strength, indicating that HIIT may offer additional benefits for patients recovering from a heart attack.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of home-based high-intensity interval training versus moderate-intensity continuous training in patients with myocardial infarction: a randomized controlled trial. Yakut, H., Dursun, H., Felekoğlu, E., et al.[2022]

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