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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
No Placebo-Only Group
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 belowSelect...
My doctor has diagnosed me with high blood pressure.
Select...
You are capable of physical exercise.
Select...
I am between 55 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with dementia.
Select...
I have been diagnosed with a lung disease.
Select...
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
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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 <i>case report</i>.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.
Exercise parameters for the chronic type B aortic dissection patient: a literature review and <i>case report</i>.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.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,343,012 Total Patients Enrolled
Ronald Lazar, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor has diagnosed me with high blood pressure.I have not received treatment for depression or anxiety.You have a stationary bike at home or can access one at a gym.I have been diagnosed with dementia.I have been diagnosed with a lung disease.I have been diagnosed with an eye disease.You are capable of physical exercise.You have a medical condition that prevents you from exercising.I am between 55 and 75 years old.You have an iPhone or Android phone or tablet that can download and use the Polar Beat and Polar FlowTM apps.I have an eye condition.
Research Study Groups:
This trial has the following groups:- Group 1: Vascular Density Improvement in Hypertensive Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 15 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 2 Months after you stop receiving the treatment.
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