Neural Activation and Connectivity in Response to Exercise and Cognitive Training (NAC)

The goal of this pilot study is to evaluate whether healthy, sedentary older adults have increased activation of specific brain areas, in response to exercise and cognitive training, in comparison to a control group, and whether improvements in psychometric test performance are related to increased activation of brain networks. Participants, between age 55-75 years will be recruited from an ongoing study of exercise and cognitive training, to undergo Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fcMRI).

Study Overview

• Status: Completed
• Conditions: Neural Connectivity
• Intervention / Treatment: Other: Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI)

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population will include 24 adults, male and female, aged 55-75 years who meet eligibility criteria for and are enrolled in the parent study, Combining Exercise and Cognitive Training to Improve Everyday Function (EXACT), Unique Protocol ID 201102416. Participants will be sedentary (not exercising regularly) but otherwise generally healthy.

Description

Inclusion Criteria:

• meet the inclusion criteria for the parent study, Combining Exercise and Cognitive Training to Improve Everyday Function (EXACT) study (Unique Protocol ID 201102416).

Exclusion Criteria:

• currently taking chronic psychotropic medication, beta blockers, or calcium channel blockers
• contraindication to MRI scanning
• inability to complete MRI scans in closed scanner

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Combined; Participants assigned to this group have been randomized to the Combined group of the parent study, Combining Exercise and Cognitive Training to Improve Everyday Function(EXACT)(Unique Protocol ID 201102416). Participants perform a 6-month standardized aerobic training program at a local recreational center, 3 times per week for 1 hour. Participants in this group also perform an 8-week cognitive training program 3 days per week for 1 hour, during months 5 and 6. The cognitive training program is computer-based, and focuses on 3 types of cognitive processes: task coordination, prospective memory, and retrospective memory retrieval. The cognitive training is conducted on concurrent days with aerobic exercise training sessions, also on site at the recreational center.	Other: Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI); All participants complete MRI scans at baseline and at the end of month 6. Scanning sessions last approximately 30 minutes each and consist of two components: (1) High resolution T1-weighted MPRAGE anatomic images to provide detailed anatomy and maximum gray-white matter contrast for images and to allow any estimate of regional or whole-brain volume, and (2) Resting BOLD functional images to allow assessment of the functional connectivity in large scale networks.
Control; Participants assigned to this group have been randomized to the Control group of the parent study, Combining Exercise and Cognitive Training to Improve Everyday Function(EXACT)(Unique Protocol ID 201102416). Participants perform a 6-month home exercise program consisting of stretching, range of motion, and simple yoga exercises designed to improve flexibility. They are instructed to perform these exercises at home at least 3 times per week for 30 - 45 minutes and record their activity on a calendar. Participants also attend weekly 1-hour Health Education sessions for 8 weeks, during months 5 and 6. These sessions cover topics unrelated to exercise or cognition, such as nutrition, hearing loss, stroke, and home energy conservation.	Other: Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI); All participants complete MRI scans at baseline and at the end of month 6. Scanning sessions last approximately 30 minutes each and consist of two components: (1) High resolution T1-weighted MPRAGE anatomic images to provide detailed anatomy and maximum gray-white matter contrast for images and to allow any estimate of regional or whole-brain volume, and (2) Resting BOLD functional images to allow assessment of the functional connectivity in large scale networks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional connectivity of large-scale brain networks as seen through Blood Oxygen Level Dependent (BOLD) functional magnetic resonance imaging (fMRI)	Change in connectivity measurements between baseline and 6 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Ellen F. Binder, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: May 2, 2012
• First Submitted That Met QC Criteria: May 18, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Estimate): September 3, 2014
• Last Update Submitted That Met QC Criteria: August 29, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: MRI; Exercise; Adult; Cognition
• Other Study ID Numbers: 201104290; 7432-01 (Other Grant/Funding Number: Barnes Jewish Hospital Foundation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No