Exercise for Age-Related Cognitive Decline

(DECLARE Trial)

Overseen By Michael Brewer, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Dementia, Untreated depression, Severe respiratory, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a short, intense exercise program can improve brain function and heart health in people with high blood pressure. The main treatment involves High Intensity Interval Training (HIIT), a type of exercise with short bursts of hard effort. Participants will exercise at home four times a week for ten weeks, guided by a fitness app. This trial suits adults aged 55-75 who have high blood pressure, are not very active, and have access to a stationary bike and a smart device. As an unphased trial, it offers participants the chance to contribute to important research on exercise and health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves exercise for those with hypertension, it's possible you may need to continue any blood pressure medications. Please consult with the trial coordinators for specific guidance.

What prior data suggests that High Intensity Interval Training (HIIT) Exercise is safe for improving vascular density in hypertensive participants?

Research shows that High Intensity Interval Training (HIIT) is generally safe and beneficial for older adults. Studies indicate that regular exercise, such as HIIT, can enhance thinking and memory. This exercise type supports brain health and may reduce the risk of dementia.

HIIT positively impacts both physical and mental health. Although some studies suggest the benefits might be less noticeable in older adults due to their current health levels, it still offers significant advantages.

Overall, many people, including older adults, find HIIT manageable. It helps overcome obstacles that might prevent exercise. Those considering this type of exercise should begin with supervision, especially if health concerns exist. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using High Intensity Interval Training (HIIT) to tackle age-related cognitive decline because it offers a fresh approach compared to traditional methods like medications or cognitive training exercises. HIIT stands out by potentially improving vascular density, especially in hypertensive individuals, which can enhance blood flow to the brain and support cognitive functions. This exercise method is also unique in its intensity and structure, where short bursts of vigorous activity are alternated with rest, making it an engaging and potentially more effective way to boost brain health. Unlike traditional treatments, HIIT can be monitored and adjusted in real-time, thanks to smart technology like heart rate monitors, ensuring a personalized and optimized intervention for each participant.

What evidence suggests that High Intensity Interval Training (HIIT) Exercise might be an effective treatment for age-related cognitive decline?

Research shows that High-Intensity Interval Training (HIIT), which participants in this trial will engage in, can improve brain function, especially in older adults. Studies have found that HIIT can enhance skills like decision-making and memory in less than eight weeks. One study discovered that HIIT helps with cognitive flexibility, which is important for multitasking and problem-solving. Regular exercise like HIIT is linked to better thinking abilities with age. However, some research suggests the benefits might be less obvious in older adults due to varying starting levels of brain function. Overall, strong evidence indicates that HIIT can positively impact brain health and thinking skills. ^{1 2 6 7 8}

Who Is on the Research Team?

Ronald Lazar, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults aged 60-75 with high blood pressure who don't exercise much (less than 150 minutes of moderate activity per week). They must be able to exercise, have a smart device, and access to an upright cycle ergometer. People with very low or very high blood pressure, severe lung disease, untreated mental health issues, dementia, significant eye problems or conditions preventing exercise cannot join.

Inclusion Criteria

My doctor has diagnosed me with high blood pressure.

You have a stationary bike at home or can access one at a gym.

engages in less than 150 minutes of moderate intensity exercise/week (as determined by CHAMPS Questionnaire)

Exclusion Criteria

I have not received treatment for depression or anxiety.

I have been diagnosed with dementia.

Have you been diagnosed with Substance Abuse?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline visits include neurocognitive testing, VO2 max testing, blood draws, and retinal scans

1-2 weeks

2 visits (in-person)

Exercise Intervention

Participants engage in supervised cardiovascular exercise with heart rate monitoring 4 days per week

10 weeks

At-home exercise, supervised virtually

Follow-up

Participants are monitored for cognitive, exercise, and retinal microvascular changes after the intervention

2-4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High Intensity Interval Training (HIIT) Exercise

Trial Overview The study tests if High Intensity Interval Training (HIIT) can improve brain function in older adults by increasing fitness and vascular health. Participants will do HIIT exercises while the researchers measure growth factors in their blood and use retinal scans to check changes in their vascular networks.

How Is the Trial Designed?

Group I: Vascular Density Improvement in Hypertensive Participants Experimental Treatment 1 Intervention

Participants will undergo baseline visits and follow-up visits to include neurocognitive testing, VO2 max testing (graded exercise test), blood draws, and retinal scans. Potential subjects must pass an exercise stress test with 12-lead ECG, and training sessions (exercise protocol). Standardized neurocognitive tests assessing functions such as memory and attention will be administered and retinal scans will be conducted. The at-home exercise intervention will be supervised via the Polar beat/flow applications by study personnel. Subjects will engage in cardiovascular exercise with heart rate monitoring on 4 days per week for a total of 10 weeks.

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

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 12-week study involving 29 overweight and obese elderly individuals showed that both high-intensity interval training (HIIT) and vigorous-intensity continuous training (VICT) significantly improved physical fitness measures like VO2max and flexibility, but HIIT was more effective in increasing VO2max and serum neurotrophin-3 levels.

Despite improvements in physical fitness and neurotrophic factors, there were no significant changes in cognitive function scores, suggesting that while HIIT and VICT enhance physical health, their impact on cognitive function may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term high-intensity interval training increases serum neurotrophic factors in elderly overweight and obese Chinese adults. Li, X., Han, T., Zou, X., et al.[2022]

A scoping review of 69 studies on high-intensity interval training (HIIT) in older adults found that HIIT protocols are generally well-tolerated and can provide significant health benefits, particularly in improving cardiorespiratory fitness.

Most research has focused on healthy older adults, highlighting a need for larger studies and more investigation into HIIT's effects on older adults with various health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training in Older Adults: a Scoping Review. Marriott, CFS., Petrella, AFM., Marriott, ECS., et al.[2021]

High-intensity interval training (HIIT) has been shown to significantly improve various health outcomes, including cardiorespiratory fitness, muscle mass, and mental health indicators like anxiety and depression, across diverse populations, as evidenced by 33 systematic reviews involving both healthy individuals and those with health complications.

HIIT is considered safe, with no reported acute injuries and high adherence rates exceeding 80%, suggesting it is a feasible exercise option for many people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. Martland, R., Mondelli, V., Gaughran, F., et al.[2023]

High-Intensity Interval Training (HIIT) is a time-efficient exercise method that may provide similar or superior cardiovascular and cerebrovascular benefits compared to Moderate-Intensity Continuous Training (MICT), which is important for preventing neurovascular diseases in older adults.

Despite the known benefits of MICT, there is a lack of randomized controlled trials (RCTs) specifically examining the effects of HIIT on brain health, highlighting the need for future research to explore its potential neuroprotective effects in an aging population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIITing the brain with exercise: mechanisms, consequences and practical recommendations. Calverley, TA., Ogoh, S., Marley, CJ., et al.[2021]

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]

A 6-month randomized controlled trial will assess the effects of aerobic training (AT), resistance training (RT), and their combination on cognitive function in 216 older adults (ages 65-85) with mild cognitive impairment (MCI).

The study aims to determine how different types of exercise can help prevent cognitive decline and potentially delay the onset of dementia, highlighting the importance of exercise as a therapeutic intervention for cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reshaping the path of mild cognitive impairment by refining exercise prescription: a study protocol of a randomized controlled trial to understand the "what," "for whom," and "how" of exercise to promote cognitive function. Barha, CK., Falck, RS., Best, JR., et al.[2022]

Acute high intensity interval training (HIIT) and sprint interval training (SIT) have shown significant improvements in cognitive functions related to work performance, such as attention and memory, in 18 out of 36 studies reviewed, involving a total of 11 to 945 participants.

Despite the promising results, most studies were conducted in controlled environments rather than actual workplace settings, indicating a need for further research to explore the practical applications of HIIT/SIT on cognitive function in real-world job scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High intensity and sprint interval training, and work-related cognitive function in adults: A systematic review. Gilson, ND., Andersson, D., Papinczak, ZE., et al.[2023]

A 3-month high-intensity intervallic functional training (HIFT) program significantly improved cognitive functions in elderly individuals with mild cognitive impairment, as evidenced by better scores in cognitive impairment, attention, verbal fluency, and concentration compared to a control group.

The study involved 132 participants aged over 65, and the results suggest that incorporating HIFT into therapeutic approaches for the elderly could be beneficial for cognitive health, particularly as it emphasizes functional training and high intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Cognition in Older Adults with Mild Cognitive Impairment through High-Intensity Functional Training: A Single-Blind Randomized Controlled Trial. Rivas-Campo, Y., Aibar-Almazán, A., Rodríguez-López, C., et al.[2023]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

A study involving 69 older adults showed that high-intensity interval training (HIIT) significantly improved cognitive flexibility, as measured by faster reaction times on the Stroop Task, compared to moderate-intensity continuous training (MICT) and resistance training (RT) after six weeks of exercise.

While all exercise groups improved cardiorespiratory fitness, only the HIIT group demonstrated enhanced executive function, suggesting that HIIT may be particularly effective in combating cognitive decline in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training Improves Cognitive Flexibility in Older Adults. Mekari, S., Neyedli, HF., Fraser, S., et al.[2020]

A systematic review of 7 randomized controlled trials found that High-Intensity Functional Training (HIFT) may improve general cognition in older adults with cognitive impairment, with two studies showing positive effects using progressive HIFT protocols.

However, the overall results were mixed, as four studies reported no significant cognitive changes, indicating that the effectiveness of HIFT may vary based on intervention protocols and measurement methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of High-Intensity Functional Training on Cognition in Older Adults with Cognitive Impairment: A Systematic Review. Rivas-Campo, Y., García-Garro, PA., Aibar-Almazán, A., et al.[2023]

Citations

1. nature.com nature.com/articles/s41598-024-83802-9

The effects of high-intensity interval training on cognitive ... Acute HIIT improved executive function, less than 8 weeks of HIIT improved executive function and memory, and more than 8 weeks of HIIT improved ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7693870/

High-Intensity Interval Training Improves Cognitive ... Engaging in regular physical activity and exercise has been associated with greater higher order cognitive functions in older adults.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11922960/

Meta-analysis of high-intensity interval training effects on ... Our meta-analysis demonstrates that HIIT significantly enhances specific cognitive functions, particularly cognitive flexibility, working memory, task-switching ...

4. frontiersin.org frontiersin.org/journals/aging/articles/10.3389/fragi.2025.1589730/full

Effects of high-intensity interval training on physical and ... We found that HIIT had less influence on both physical and cognitive function than expected, which may be because function in this age group remains relatively ...

5. biorxiv.org biorxiv.org/content/10.1101/2025.02.13.638126v1

Effects of High-Intensity Interval Training on Physical and ... We found that HIIT had less influence on either physical or cognitive function than we expected, which may be because function in this age group ...

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

Acute effects of high-intensity interval training and ... In conclusion, our study indicates that HIIT's beneficial effects on executive functions demonstrated a larger effect size than those of MICT.

7. ijrep.org ijrep.org/download/2957/

Investigating the Effect of High Intensity Interval Training ... Interval training provides a methodical framework that helps overcome the psychological barriers and physical limitations that typically prevent older adults.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0306987725001641

High intensity interval training and its impact on brain- ... Exercise training in middle-aged or older adults improves cognitive thinking and memory and reduces dementia rates [10,25,26].