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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to test the effects of 10 weeks of exercise on overall brain health, reduction in blood pressure, and the number of blood vessels in the back of the eyes in patients with hypertension and have a body mass index ≥ 25 kg/m2. The main question\[s\] it aims to answer are: * To test the effect of moderate vs intensive exercise on Brain Care Score outcomes. * To ascertain the differential impact of moderate vs high intensity exercise in reducing hypertension and its downstream effects.

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 exercise intervention generally safe for brain health?

Research shows that exercise is generally safe and beneficial for brain health, improving memory, learning, and reducing risks like diabetes and high blood pressure, which can harm the brain. ^{1 2 3 4 5}

How is the Exercise Intervention treatment different from other treatments for brain health?

The Exercise Intervention treatment is unique because it uses physical activity to improve brain health by promoting brain plasticity, enhancing neurogenesis (growth of new brain cells), and regulating neurotrophic factors, which are proteins that support neuron growth and function. Unlike drug therapies, this non-drug approach leverages the body's natural processes to improve cognitive function and reduce the risk of neurological disorders without the side effects associated with medications. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Exercise Intervention for improving brain health?

Research shows that physical exercise can improve brain health by reducing inflammation, enhancing brain structure and function, and boosting cognitive abilities. It has been effective in conditions like traumatic brain injury and dementia, suggesting it can also benefit overall brain health. ^{3 9 10 11 12}

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.

I did not pass the fitness evaluation.

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 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]

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

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

Exercise builds brain health: key roles of growth factor cascades and inflammation. [2022]

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

Physical exercise and cognitive recovery in acquired brain injury: a review of the literature. [2022]

3. Denmark pubmed.ncbi.nlm.nih.gov

Physical exercise ameliorates deficits induced by traumatic brain injury. [2012]

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

Exercise Reshapes the Brain: Molecular, Cellular, and Structural Changes Associated with Cognitive Improvements. [2023]

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

Effects of Physical Activity Programs on the Improvement of Dementia Symptom: A Meta-Analysis. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Lifestyle and cognition: what do we know from the aging and neurodegenerative brain?]. [2021]

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

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

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

Exercise, cognition, and the aging brain. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Physical exercise promotes brain remodeling by regulating epigenetics, neuroplasticity and neurotrophins. [2022]

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

Potential exerkines for physical exercise-elicited pro-cognitive effects: Insight from clinical and animal research. [2020]

11. Belgium pubmed.ncbi.nlm.nih.gov

[Preserve brain function...through physical exercice?]. [2015]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise Intervention in Treatment of Neuropsychological Diseases: A Review. [2020]