Improving Age-Related Cognitive Decline With Exercise in Hypertensive Older Adults

Hypertension Clinical Trial

— DECLARE  

Official title:

Improving Age-Related Cognitive Decline With Exercise in Hypertensive Older Adults: A Pilot Study to Investigate A Retinal Microvascular Biomarker and the Role of IGF

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043454
• Other study ID #: IRB-300007742
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: September 2023
• Source: University of Alabama at Birmingham
• Contact: Ronald Lazar, PhD
• Phone: 205-934-2334
• Email: rlazar[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigator aims to assess the extent to which a brief exercise intervention improves systemic growth factor concentrations, reverses loss of systemic vascular networks and hypertension, and by extension, improves neurocognition. To test the investigator's hypothesis that increased cardiovascular fitness will correlate with improved vascular density, the investigator proposes the innovative use of retinal density scans.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• adults between 55-75 years of age
• essential hypertension (as determined by referring physicians)
• engages in less than 150 minutes of moderate intensity exercise/week (as determined by CHAMPS Questionnaire)
• physically able to exercise
• access to an upright cycle ergometer at home or via gym access
• access to smart device (iOS or Android phone or tablet with ability to install and use Polar Beat and Polar FlowTM applications).

Exclusion Criteria:

• diagnosis of dementia
• resting systolic blood pressure <120, or >180 mm Hg
• disease or condition that would preclude exercise
• untreated depression or anxiety disorders
• severe respiratory disease
• disease of the eye
• refractive error > 6 diopters or +6 diopters (as assessed by 1st retinal scan).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Hypertension

Intervention

Other:
• High Intensity Interval Training (HIIT) Exercise
Participants will exercise 4 days/week for 10 weeks using the High Intensity Interval Training (HIIT) protocol. Sessions can be conducted at home or at a gym with access to a cycle ergometer. Participants will undergo 2 supervised training sessions to learn the HIIT protocol. To record heart rate, session duration, and time at each exercise intensity, participants will be provided with an H10 Polar TM heart rate chest strap monitor and a Polar Beat/Polar Flow account. Participants will download the Polar Beat/Flow smart phone application to record exercise sessions and allow the researcher to conduct remote data monitoring. Research staff will contact participants twice per week to provide feedback.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in graded exercise stress test	This test will measure participants' maximal oxygen utilization and will be done once before and once after exercise intervention. The investigator will use a graded exercise test on a stationary cycle. The test will continue to maximum, and expired gases will be collected (via a spirometer) throughout the test to monitor oxygen consumption and carbon dioxide expiration. The investigator defines maximum or test termination as either voluntary exhaustion by the participant, or by two of three physiologic criteria: 1) heart rate = 220 minus age; 2) respiratory exchange ratio > 1.15; 3) Stabilization of oxygen consumption with increasing workload. The participant's effort is monitored at each test stage via the standard 6-20 rating of a perceived exertion scale. Lactate levels will also be collected by finger prick to help determine maximum.	16 weeks
Primary	Retinal microvascular density changes	Standardized Optical Coherence Tomography Angiography (OCT-A) scans will occur twice before and once after exercise intervention to measure retinal microvascular density changes. A fractal analysis will be used to uniquely analyze the retinal microvascular network so that global changes of the vascular system can be quantified.	16 weeks
Primary	Cognitive changes	Standardized neuropsychological tests will be completed twice before and once after exercise intervention. These are designed to assess global functions of processing speed, memory, attention, and executive function, which have been shown to be sensitive to diffuse effects of cardiogenic, cerebral hypoperfusion. All tests have published, aged-adjusted norms. Specific tests include: Trail making A & B, Digit Span; Rey Complex Figure (RCFT); Digit Symbol; Controlled Oral Word Association (verbal fluency); Hopkins Verbal Learning Test (HVLT); Boston Naming Test; Center for Epidemiologic Studies-Depression Scale (CES-D), and the Brief Visual Memory Test (BVMT). At each time point, the Z scores for all measures will be aggregated and divided by 9 to arrive at the total cognitive Z-score. In addition, we will calculate composite scores for separate cognitive domains using the same approach and compare each time point to measure total cognitive changes.	16 weeks
Primary	Serum growth factor changes	Approximately 2 teaspoons (10 mL) of venous blood draw will occur twice before and once after exercise intervention to measure serum growth factor changes.	16 weeks