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

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Interval Training (HIIT) Exercise
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adults between 60-75 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).

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vascular Density Improvement in Hypertensive Participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2021
Last Updated
October 19, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05043454
Brief Title
Improving Age-Related Cognitive Decline With Exercise in Hypertensive Older Adults
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vascular Density Improvement in Hypertensive Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training (HIIT) Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in graded exercise stress test
Description
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.
Time Frame
16 weeks
Title
Retinal microvascular density changes
Description
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.
Time Frame
16 weeks
Title
Cognitive changes
Description
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.
Time Frame
16 weeks
Title
Serum growth factor changes
Description
Approximately 2 teaspoons (10 mL) of venous blood draw will occur twice before and once after exercise intervention to measure serum growth factor changes.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald Lazar, PhD
Phone
205-934-2334
Email
rlazar@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Brewer, MA
Phone
205-996-5592
Email
michaeltbrewer@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Lazar, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Lazar, PhD
Phone
205-934-2334
Email
rlazar@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Michael Brewer, MA
Phone
205-996-5592
Email
michaeltbrewer@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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