Exercise Training for High Blood Pressure

Overseen By Marc Cook, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: North Carolina Agriculture & Technical State University

Must not be taking: Hypertension, Anti-inflammatories, Statins, Thyroid

Disqualifiers: Uncontrolled hypertension, Heart disease, Diabetes, Inflammatory diseases, 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: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how exercise can lower blood pressure and improve gut health, particularly for African Americans with hypertension and related gut issues. Participants with high blood pressure will engage in a supervised exercise program to determine its effects on gut health and blood pressure reduction. Potential participants include individuals with high blood pressure who do not exercise regularly. The trial excludes those with severe health conditions such as heart disease or diabetes. As an unphased trial, this study offers a unique opportunity to contribute to understanding the benefits of exercise on blood pressure and gut health.

Will I have to stop taking my current medications?

Yes, if you are taking medications for hypertension or those affecting inflammation or metabolic function, you must stop taking them at least one month before joining the trial.

What prior data suggests that this exercise training is safe for individuals with hypertension?

Research shows that exercise is generally safe and manageable. Studies have found that regular exercise can lower blood pressure by 5 to 7 mm Hg in individuals with high blood pressure. This reduction is significant and indicates that exercise can help control high blood pressure.

Moreover, evidence suggests that exercise rarely causes problems. It can, in fact, boost heart health and overall fitness. These studies report no serious side effects from exercise.

Prospective trial participants can feel assured about the safety of exercise as a treatment. It is a proven and safe way to help manage blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard medications for high blood pressure, like ACE inhibitors or beta-blockers, which primarily target the heart and blood vessels chemically, exercise training offers a natural approach to managing hypertension. Researchers are excited about this treatment because it not only helps in lowering blood pressure through physical activity but also improves overall cardiovascular health. Additionally, exercise training can lead to a variety of other health benefits, such as improved mood and increased energy levels, making it a holistic alternative to traditional medication.

What evidence suggests that exercise training might be an effective treatment for high blood pressure?

Research has shown that exercise can effectively lower blood pressure. In this trial, participants with hypertension will engage in a supervised aerobic exercise intervention for three months. Studies indicate that regular physical activity reduces both systolic (the top number) and diastolic (the bottom number) blood pressure readings. Aerobic exercises, such as walking or cycling, are particularly beneficial for individuals with slightly elevated blood pressure. Exercise also enhances heart health and boosts metabolism. These benefits make it a promising method for managing high blood pressure by improving gut health and blood flow. ^{2 3 5 6 7}

Who Is on the Research Team?

Marc Cook, PhD

Principal Investigator

North Carolina Agriculture & Technical State University

Are You a Good Fit for This Trial?

This trial is for African Americans aged 30-50 who are sedentary, have slightly elevated to stage 1 high blood pressure but no other major health issues like heart disease, kidney or lung diseases, and aren't on medications that affect blood pressure. Smokers and pregnant women can't participate.

Inclusion Criteria

You don't exercise regularly and have a job that involves sitting most of the time.

I am between 30 and 50 years old.

Your blood pressure is within the normal range (systolic BP: 90-120 mmHg/diastolic BP: 60-80 mmHg).

Exclusion Criteria

I have taken medication for blood pressure, inflammation, cholesterol, or thyroid in the last month.

Pregnant females

You have heart-related symptoms during exercise testing that would prevent you from doing vigorous physical activity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants with hypertension perform 3 months of supervised aerobic exercise (5 days/week) and submit blood and fecal samples every 4 weeks

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Training

Trial Overview The study investigates how exercise training affects high blood pressure and gut microbial diversity in African Americans. It aims to understand if improving gut health through exercise can help lower blood pressure.

How Is the Trial Designed?

Group I: Hypertension (Exercise Intervention) Experimental Treatment 1 Intervention

Participants with hypertension will submit blood and fecal samples for comparison to control participants with normal blood pressure. Control group will only donate fecal and blood samples and will not participate in the exercise intervention. Participants with hypertension will also perform 3 months of supervised aerobic exercise (5 days/week) and submit blood and fecal samples every 4 weeks until the completion of the study.

Who Is Running the Clinical Trial?

North Carolina Agriculture & Technical State University

Lead Sponsor

Trials

9

Recruited

180+

Published Research Related to This Trial

Aerobic exercise is highly effective in reducing blood pressure, especially in hypertensive patients, with guidelines recommending 30-60 minutes of moderate to vigorous exercise 4-7 days a week as a primary strategy for managing hypertension.

While resistance training is considered safe and can be included as an adjunct to aerobic exercise, its role in directly managing hypertension is less established, and it is recommended to be performed 2-3 days a week with proper medical clearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as medicine: role in the management of primary hypertension. Millar, PJ., Goodman, JM.[2014]

Physical conditioning can be an effective alternative or complement to medication for managing borderline or mild hypertension, as studies show it can lead to modest reductions in blood pressure.

Exercise programs for hypertensive patients should be personalized based on individual assessments and may include activities like arm crank ergometry and moderate weight training, while avoiding pure isometric exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise prescription for hypertensive patients. Franklin, BA., Gordon, S., Timmis, GC.[2019]

Isometric resistance training (IRT) has been shown to significantly lower blood pressure by an average of 7.4/3.3 mmHg, which is comparable to the effects of antihypertensive medications, and can reduce the risk of major cardiovascular events by 13% to 22%.

IRT is safe for a variety of patient populations and is particularly beneficial for individuals who cannot engage in aerobic exercise or have resistant hypertension, requiring only about 17 minutes of training per week.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based guide to the efficacy and safety of isometric resistance training in hypertension and clinical implications. Baffour-Awuah, B., Pearson, MJ., Dieberg, G., et al.[2023]

Dynamic resistance training can be safely included in cardiac rehabilitation for selected patients, as it does not pose a higher risk than aerobic training when properly supervised and tailored to individual needs.

Low-intensity resistance training (40-60% of maximum voluntary contraction) with controlled repetitions leads to only modest increases in blood pressure, similar to moderate endurance training, making it a viable option for improving muscle strength and cardiovascular health in patients with good cardiac function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for resistance exercise in cardiac rehabilitation. Recommendations of the German Federation for Cardiovascular Prevention and Rehabilitation. Bjarnason-Wehrens, B., Mayer-Berger, W., Meister, ER., et al.[2019]

Regular physical activity is crucial for controlling blood pressure in individuals with mild hypertension, potentially preventing related health issues and reducing mortality rates.

For effective blood pressure management through exercise, it is recommended to engage in aerobic activities at 55-85% of maximal heart rate, aiming for a weekly energy expenditure of 14-20 kcal/kg of body weight, while considering any interactions with antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and mild essential hypertension. Gordon, NF., Scott, CB.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4624627/

Influence of Physical Activity on Hypertension and Cardiac ... A number of studies consistently demonstrate beneficial effects of exercise on hypertension with reductions in both systolic and diastolic blood pressure with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4369613/

Evidence for exercise training in the management of ... Overall, evidence suggests that dynamic resistance exercises can lower BP by a modest degree, especially in stage 1 hypertension, with no evidence of harm, ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001289

Core Components of Cardiac Rehabilitation Programs Progressive resistance exercise training independently leads to improved strength, balance, metabolism, and functional independence in patients ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1109966623001458

Exercise and cardiac rehabilitation in hypertensive patients ... This position statement provides a general framework for exercise and exercise-based rehabilitation in patients with hypertension and HFpEF.

5. bjsm.bmj.com bjsm.bmj.com/content/57/20/1317

Exercise training and resting blood pressure: a large-scale ... Overall, isometric exercise training is the most effective mode in reducing both systolic and diastolic blood pressure. These findings provide a comprehensive ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537196/

Cardiac Rehabilitation - StatPearls - NCBI Bookshelf Studies show that cardiac rehabilitation is safe, has a low risk of complications, and offers benefits such as improved cardiovascular function, ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2022.07.004

Exercise for Primary and Secondary Prevention of ... Both aerobic and resistance exercise training reduce systolic and diastolic BP by 2 to 5 mm Hg in normotensive adults and by 5 to 7 mm Hg in hypertensive adults ...