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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 will test whether a brief exercise intervention can improve vascular density and, by extension, neurocognition in hypertensive patients.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.

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.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,599 Previous Clinical Trials
2,287,890 Total Patients Enrolled
Ronald Lazar, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

High Intensity Interval Training (HIIT) Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05043454 — N/A
High Blood Pressure Research Study Groups: Vascular Density Improvement in Hypertensive Participants
High Blood Pressure Clinical Trial 2023: High Intensity Interval Training (HIIT) Exercise Highlights & Side Effects. Trial Name: NCT05043454 — N/A
High Intensity Interval Training (HIIT) Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05043454 — N/A
~2 spots leftby Oct 2024