Exercise Intervention for Brain Health

Recruiting in Palo Alto (17 mi)

Overseen by Pamela G. Bowen, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: No hypertension, weight over 300 lbs, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

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.

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. ^{1 2 3 4 5}

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 6 7 8 9}

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. ^{4 9 10 11 12}

Research Team

Pamela G. Bowen, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Exercise Intervention to improve overall Brain Health (Behavioural Intervention)

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.

Participant Groups

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+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

References

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]