Exercise Intervention for Brain Health

Overseen By Tasha Smith, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: No hypertension, weight over 300 lbs, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different exercise routines can improve brain health and lower blood pressure in individuals with high blood pressure (hypertension) who are also overweight (BMI 25 or above). Researchers aim to determine whether moderate or high-intensity workouts are more effective in enhancing brain function and reducing health risks associated with hypertension. Participants will be divided into three groups: moderate exercise, high-intensity exercise, and a group following standard exercise advice. This trial suits those diagnosed with hypertension, having a BMI of 25 or more, and able to use a smartphone to track workouts. As an unphased trial, it offers a unique opportunity to contribute to understanding how exercise impacts health, potentially benefiting participants' well-being and others in the future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

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

Research shows that moderate exercise is usually manageable and can improve brain functions like learning and memory. For instance, one study found that this type of exercise helped older adults think better and increased blood flow to their brains, indicating its safety and benefits for brain health.

Regarding high-intensity interval training (HIIT), studies have found it can enhance thinking skills and improve mood, even after just one session. It is considered a strong exercise for brain health and is generally well-received. Both moderate and high-intensity exercises have been linked to positive effects on brain health, with no major negative effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different exercise interventions can boost brain health, a fresh approach compared to traditional methods like medication or cognitive therapy. The trial involves two experimental exercise regimens: Moderate Intensity Training (MIT) and High Intensity Interval Training (HIIT). Unlike conventional treatments, these exercise protocols aim to enhance brain health through physical activity, which may offer a non-invasive, accessible, and holistic way to improve cognitive function. By examining these specific exercise strategies, researchers hope to uncover new insights into how physical activity can directly impact brain health, potentially leading to innovative recommendations for maintaining cognitive vitality.

What evidence suggests that this trial's exercise interventions could be effective for brain health and hypertension?

This trial will compare different exercise interventions for brain health. Studies have shown that moderate intensity training (MIT), which participants in one arm of this trial will follow, can improve memory and thinking skills. Research suggests that this type of exercise boosts brain health by helping brain connections change and encouraging the growth of new brain cells. Meanwhile, participants in another arm will engage in high intensity interval training (HIIT), which has significantly enhanced abilities like switching between tasks and remembering information. HIIT is thought to help maintain the size of the hippocampus, a key part of the brain for memory. Both types of exercise seem to benefit brain health, but in slightly different ways. ^{6 7 8 9 10}

Who Is on the Research Team?

Pamela G. Bowen, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals aged 35-65 with hypertension and a BMI of at least 25 kg/m2. Participants must have a smartphone capable of installing two workout tracking apps and pass a fitness evaluation. Those over 300 lbs or without hypertension, as well as those who fail the fitness test or have a BMI under 25, cannot join.

Inclusion Criteria

I am between 35 and 65 years old.

You weigh more than what is considered healthy for your height.

I have been diagnosed with high blood pressure.

Exclusion Criteria

I do not have high blood pressure.

You weigh less than what is considered healthy for your height.

You weigh more than 300 pounds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in exercise interventions for 10 weeks, following either a moderate intensity training (MIT) or high intensity interval training (HIIT) protocol, or follow AHA guidelines

10 weeks

Participants exercise independently 4 days/week

Follow-up

Participants are monitored for safety and effectiveness after the exercise intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention to improve overall Brain Health

Trial Overview

The study examines how moderate versus intensive exercise affects brain health over ten weeks. It looks at changes in brain health scores, blood pressure reduction, and eye blood vessel count in overweight patients with high blood pressure.

How Is the Trial Designed?

Group I: Moderate Intensity Training (MIT) exercise group Experimental Treatment 1 Intervention

Participants will be asked to exercise independently 4 days/week for 10 weeks, following a moderate intensity training (MIT) protocol.

Group II: High Intensity Interval Training (HIIT) exercise group, Experimental Treatment 1 Intervention

Participants will be asked to exercise independently 4 days/week for 10 weeks, following a high intensity interval training (HIIT) protocol.

Group III: Control exercise group Active Control 1 Intervention

Participants will be advised to follow the American Heart Association (AHA) guidelines on exercise.

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

Exercise interventions can significantly improve outcomes in individuals with traumatic brain injury (TBI) by reducing inflammation and promoting neuroplasticity, which are crucial for recovery.

Tailoring physical exercise programs to the specific type and severity of TBI can enhance their effectiveness, making exercise a valuable non-pharmacologic treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise ameliorates deficits induced by traumatic brain injury. Archer, T., Svensson, K., Alricsson, M.[2012]

A meta-analysis of nine studies showed that physical activity significantly improves symptoms of dementia, particularly enhancing physical capacity with a high effect size of 1.05.

Combined exercise was identified as the most effective type of physical activity for improving various aspects of dementia symptoms, including daily living activities and cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Physical Activity Programs on the Improvement of Dementia Symptom: A Meta-Analysis. Lee, HS., Park, SW., Park, YJ.[2022]

Regular physical exercise can significantly benefit mental health by stimulating brain function and improving the supply of oxygen and nutrients, which helps maintain or restore normal nervous system functioning.

Exercise interventions have shown positive effects on various neuropsychological disorders, such as depression and anxiety, and may serve as a valuable alternative to drug therapies, which often have side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Intervention in Treatment of Neuropsychological Diseases: A Review. Chen, Z., Lan, W., Yang, G., et al.[2020]

Regular physical activity and a balanced diet have been shown to improve not only motor symptoms but also cognitive function in both healthy elderly individuals and those with neurodegenerative disorders like Parkinson's and Alzheimer's disease.

Emerging evidence suggests that these lifestyle changes may enhance brain health by increasing neurotrophic factors and promoting the growth of grey matter in areas associated with learning and memory, offering promising noninvasive treatment options for cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lifestyle and cognition: what do we know from the aging and neurodegenerative brain?]. Steiner, B., Witte, V., Flöel, A.[2021]

Chronic aerobic exercise has been shown to positively impact various brain functions throughout a person's life, suggesting a strong link between physical activity and brain health.

Engaging in regular physical activity may help lower the risk of developing age-related neurological disorders like Alzheimer's and Parkinson's diseases, although the exact mechanisms behind these benefits are still not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preserve brain function...through physical exercice?]. Garraux, G.[2015]

Exercise has been shown to enhance brain functions, particularly in improving memory and learning in age-related neurodegenerative diseases, based on various studies in both humans and animal models.

The review highlights that exercise promotes beneficial changes in the brain, such as regulating epigenetics, enhancing synaptic plasticity, and increasing neurogenesis, suggesting it could serve as a non-drug therapy for neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise promotes brain remodeling by regulating epigenetics, neuroplasticity and neurotrophins. Liang, J., Wang, H., Zeng, Y., et al.[2022]

Epidemiological studies indicate that regular exercise and physical activity are associated with improved cognitive function and a reduced risk of dementia in humans.

Randomized clinical trials, although limited, suggest that exercise training can positively impact cognitive abilities, supported by animal research showing molecular and cellular benefits from physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise, cognition, and the aging brain. Kramer, AF., Erickson, KI., Colcombe, SJ.[2022]

Animal studies indicate that physical exercise significantly enhances cognitive recovery after acquired brain injury (ABI) by promoting neural growth factors and neurogenesis, leading to improved memory function.

In humans, while some studies show a positive link between physical exercise and cognitive improvements after ABI, the evidence is less consistent, highlighting the need for more controlled research to clarify these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise and cognitive recovery in acquired brain injury: a review of the literature. Devine, JM., Zafonte, RD.[2022]

Exercise has been shown to prevent and improve various brain disorders, including dementias and Parkinson's disease, highlighting its potential as a therapeutic intervention.

The review discusses mechanisms behind these benefits, such as the role of neurotrophic factors, which are important for brain health and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as a Positive Modulator of Brain Function. Alkadhi, KA.[2019]

Regular physical exercise is linked to improved brain health and plasticity, particularly in areas like the hippocampus and prefrontal cortex, which are crucial for learning, memory, and mood regulation.

The benefits of exercise on brain health may be mediated by various exerkines, such as myokines from muscles and adipokines from fat, highlighting the complex biological mechanisms behind exercise-induced neuroplasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential exerkines for physical exercise-elicited pro-cognitive effects: Insight from clinical and animal research. Lee, TH., Formolo, DA., Kong, T., et al.[2020]

Exercise significantly enhances brain health by improving learning, memory, and protecting against neurodegeneration, especially in older adults, through mechanisms like increased synaptic plasticity and neurogenesis.

The benefits of exercise are mediated by the induction of growth factors that promote structural and functional changes in the brain, while also reducing risk factors like diabetes and hypertension that can lead to brain dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise builds brain health: key roles of growth factor cascades and inflammation. Cotman, CW., Berchtold, NC., Christie, LA.[2022]

Physical exercise is an effective non-drug therapy that can enhance brain health by promoting cognitive improvements and preventing cognitive decline associated with aging and neurological conditions.

The benefits of exercise on the brain are linked to mechanisms such as the release of neurotrophins, increased neurogenesis in the hippocampus, reduced neuroinflammation, and improved blood flow, which together contribute to better brain function and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Reshapes the Brain: Molecular, Cellular, and Structural Changes Associated with Cognitive Improvements. Augusto-Oliveira, M., Arrifano, GP., Leal-Nazaré, CG., 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/PMC8157174/

High-Intensity Interval Training upon Cognitive and ...

One study found a positive effect of HIIT (4 weeks, 3 sessions/week, ≥85% HRmax, aerobic and core exercises) on executive function [23]. Another ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0306987725001641

High intensity interval training and its impact on brain- ...

Our novel hypothesis is HIIT will maintain hippocampal volume and cognitive function more than low intensity constant-rate exercise in patients diagnosed with ...

4.

frontiersin.org

frontiersin.org/journals/physiology/articles/10.3389/fphys.2025.1543217/full

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 ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9256523/

Can exercise shape your brain? A review of aerobic ...

Recent reviews have observed that best cognitive enhancements were obtained between 11 and 21 min when exercising at moderate-to-vigorous intensity [11], and ...

6.

pmc.ncbi.nlm.nih.gov

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

High-Intensity Interval Training Improves Cognitive ...

We demonstrated that as little as six weeks of HIIT elicited improvements in higher-order cognitive functions that may combat the age-associated ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10341129/

Little but Intense: Using a HIIT-Based Strategy to Improve ...

A single bout of HIIT induces acute positive changes in mood states in male college students and seems to be a powerful stimulus for cognitive functioning.

8.

nature.com

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

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

Numerous studies have demonstrated that executive functions benefit from high-intensity interval training (HIIT) and moderate-intensity ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04724499

Improving Cognitive Function Through High-intensity ...

This study intends to evaluate whether HIIT can improve cognitive function as well as cardio-respiratory fitness, among patients undergoing chemotherapy for ...

10.

health.harvard.edu

health.harvard.edu/exercise-and-fitness/cognitive-benefits-from-high-intensity-interval-training-may-last-for-years

Cognitive benefits from high-intensity interval training may ...

A recent study found that engaging in high-intensity interval training may be better for brain health than other less vigorous routines.