What side effects are associated with this type of intervention?

Common treatments for high blood pressure include both pharmacologic and non-pharmacologic approaches. Pharmacologic treatments such as ACE inhibitors can cause side effects like cough, elevated blood potassium levels, and kidney dysfunction. ARBs may lead to dizziness and elevated blood potassium. Beta-blockers can cause fatigue, cold extremities, and sleep disturbances. Calcium channel blockers might result in swelling, dizziness, and constipation, while diuretics can lead to electrolyte imbalances and dehydration. Non-pharmacologic treatments, particularly exercise interventions, generally have fewer side effects but may include muscle soreness, fatigue, and, in rare cases, injury. Exercise has been shown to improve cardiovascular fitness, systemic growth factor concentrations, vascular density, and reduce hypertension, making it a beneficial adjunct to pharmacologic treatments.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of high blood pressure, including angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs), and thiazide-like diuretics. These medications have been shown to effectively lower blood pressure and reduce the risk of cardiovascular events. In addition to pharmacological treatments, exercise interventions such as aerobic training and dynamic resistance training have been studied and found to improve cardiovascular fitness, increase systemic growth factor concentrations, enhance vascular density, and reduce hypertension. Combining these exercise interventions with antihypertensive medications can provide comprehensive management of high blood pressure.

What other types of research exist?

Promising novel alternatives to exercise intervention for high blood pressure patients include: 1) Pharmacological treatments such as new antihypertensive drugs that target specific pathways involved in blood pressure regulation. 2) Lifestyle modifications including dietary interventions like the DASH diet, which is rich in fruits, vegetables, and low-fat dairy products. 3) Emerging therapies such as renal denervation, a minimally invasive procedure that disrupts nerve activity in the kidneys to lower blood pressure. 4) Use of wearable technology and telemedicine to monitor and manage blood pressure more effectively. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Exercise for Age-Related Cognitive Decline (DECLARE Trial)

Verified Trial

N/A

Recruiting

Led By Ronald Lazar, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

essential hypertension (as determined by referring physicians)

physically able to exercise

Must not have

diagnosis of dementia

Have you been diagnosed with Lung Disease?

Timeline

Screening 2 days

Treatment 15 weeks

Follow Up 2 days

Awards & highlights

Summary

This trial tests if short exercise routines can help people with high blood pressure and cognitive issues. The exercise is expected to improve heart and blood vessel health, which may lower blood pressure and boost brain function. Researchers will use eye scans to measure changes in blood vessel health.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not drug-related, side effects from HIIT may include muscle soreness, fatigue, increased heart rate during exercise, risk of injury due to intense activity especially if pre-existing conditions are present.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My doctor has diagnosed me with high blood pressure.

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You are capable of physical exercise.

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I am between 55 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with dementia.

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I have been diagnosed with a lung disease.

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I have been diagnosed with an eye disease.

Timeline

Screening ~ 2 days2 visits

Treatment ~ 15 weeks2 visits

Follow Up ~ 2 days2 visits

Screening ~ 2 days

Treatment ~ 15 weeks

Follow Up ~2 days

This trial's timeline: 2 days for screening, 15 weeks for treatment, and 2 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in graded exercise stress test

Cognitive changes

Microvascular Density

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Vascular Density Improvement in Hypertensive ParticipantsExperimental Treatment1 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include both pharmacologic and non-pharmacologic interventions. Medications such as ACE inhibitors, beta-blockers, diuretics, and calcium channel blockers work by relaxing blood vessels, reducing blood volume, or decreasing heart rate. Non-pharmacologic treatments, like regular physical activity, improve cardiovascular fitness, increase systemic growth factor concentrations, enhance vascular density, and reduce hypertension. These mechanisms are essential for high blood pressure patients as they lower the risk of cardiovascular events, improve heart health, and enhance quality of life.

Exercise parameters for the chronic type B aortic dissection patient: a literature review and case report.Effect of dance therapy on blood pressure and exercise capacity of individuals with hypertension: A systematic review and meta-analysis.Effects of drug and exercise intervention on functional capacity and quality of life in heart failure with preserved ejection fraction: A meta-analysis of randomized controlled trials.