Aerobic Exercise and Cerebrovascular Function

NCT03803904 | Active Not Recruiting Results

• 1 other identifier: E2825-R
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This proposal will evaluate two brain health measures, cerebrovascular perfusion and cerebrovascular reactivity (CVR), before and after a proven, interval-based, aerobic exercise intervention in older Veterans. The hypothesis is that the 12-week aerobic exercise intervention (Spin) will increase perfusion and improve CVR in brain regions susceptible to age-related decline. This information will inform the impact of exercise on cerebrovascular health which is known to be negatively impacted in aging and implicated in the development of neurodegenerative disease. This information will also aid the investigators' continued efforts of clinical implementation of evidence-based exercise interventions in the local Atlanta VA and surround region.

Conditions

Aging

Keywords

exercise; brain health

Outcome Measures

Primary Outcomes (1)

• Cerebrovascular Reactivity (CVR) Using a Hypercapnic CO2 Response Test Change

  CVR will be assessed using 5% CO2 challenge while continuously acquiring MR images. This method has been extensively used and is the most suitable vasoactive stimulus. Briefly, the CO2 air (5% CO2, 21% O2 and 74% N2) will be administered via an air bag with a valve to switch between room air and CO2 air in the bag. A mouth piece and a nose clip will be used to achieve mouth-only breathing. A research staff member will be inside the magnet room throughout the experiment to switch the valve and to monitor the subject. Physiologic parameters, including end-tidal (Et) CO2 and breathing rate will be monitored and recorded during the experiments. The percentage of change in Blood-Oxygen-Level-Dependent (BOLD) signal per millimeter of mercury is the metric used to quantify CVR. It measures how much the BOLD signal changes in response to a 1 mmHg change in the end-tidal partial pressure of carbon dioxide.

  At the Pre-intervention assessment and 12-weeks following at the Post intervention assessment

Study Arms (2)

Spin

EXPERIMENTAL

The intervention will take place three times a week for 12 weeks and will be led by a qualified instructor (an Exercise Physiologist with five years of experience conducting the intervention). The duration of each session will be increased by 1-2 minutes to a maximum time of 45 minutes per session based on the progression of the participants and the recommendation of the instructor. Because participants are initially sedentary and detrained, exercise intensity will begin at low levels (50% of maximal heart rate reserve, HRR) but will be increased by 5% every week (if deemed necessary by the instructor) to a maximum of 75% maximal HRR.

Other: Spin

Control

ACTIVE COMPARATOR

Participants in the control group will be equalized (frequency and duration) to the Spin group for contact and monitoring. As such they will report to the same facility and interact with the same experienced interventionist; however instead of progressive Spin exercise they will participate in sessions focused on balance and stretching. Similar to the aerobic intervention, these exercises will take place in a group setting and heart rate will be consistently monitored during each session to verify heart rate does not reach 50% HRR.

Other: Spin

Interventions

Spin OTHER

The intervention will take place three times a week for 12 weeks and will be led by a qualified instructor (an Exercise Physiologist with five years of experience conducting the intervention). The duration of each session will be increased by 1-2 minutes to a maximum time of 45 minutes per session based on the progression of the participants and the recommendation of the instructor. Because participants are initially sedentary and detrained, exercise intensity will begin at low levels (50% of maximal heart rate reserve, HRR) but will be increased by 5% every week (if deemed necessary by the instructor) to a maximum of 75% maximal HRR.

Control; Spin

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Adults aged 65-80 who do not regularly exercise
• defined as exercising less than 20 minutes twice per week
• Are willing and able to cooperate with assessments and interventions
• Participant will be quantified at or below the "poor" range for cardiovascular fitness as assessed by a volume of oxygen (VO2) test
• ml/kg/min for males
• ml/kg/min for females)
• on the MoCA to meet the criteria for cognitively intact
• Participants will be free from diseases affecting cognition or that would interfere with their ability to engage in aerobic exercise - including but not limited to:
• chronic heart
• liver
• kidney disease
• Free from diseases/injuries directly affecting brain functions - including but not limited to:
• significant closed head injury
• open intracranial wounds
• stroke

You may not qualify if:

• Potential participants with major psychiatric disorder - including but not limited to:
• psychosis
• major depression
• bipolar disorder
• Individuals with ongoing drug or alcohol abuse and severe hypertension (systolic BP \> 200 or diastolic BP \> 110 mm Hg or subjects taking three or more antihypertensive medications
• Participants must not have conditions incompatible with MRI - including but not limited to:
• ferrous metal implants
• cardiac pacemakers or similar devices
• claustrophobia
• morbid obesity
• Persons engaging in significant skilled manual movements regularly will be excluded so that behavioral/motor measures reflect the effects of age and aerobic exercise and not the effects of frequent practice

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

spindlin

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Joe Nocera
• Organization: Department of Veterans Affairs

jnocera@emory.edu

404 321 6111

Study Officials

• Joe R. Nocera, PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 15, 2019
• Study Start: April 1, 2019
• Primary Completion: January 10, 2025
• Study Completion: May 1, 2026
• Last Updated: May 7, 2026
• Results First Posted: March 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)