Neural Activation and Connectivity in Response to Exercise and Cognitive Training - Full Text View

Purpose

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).

Condition	Intervention
Neural Connectivity	Other: Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI)

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Neural Activation and Connectivity in Response to Exercise and Cognitive Training

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Oxygen Therapy

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Functional connectivity of large-scale brain networks as seen through Blood Oxygen Level Dependent (BOLD) functional magnetic resonance imaging (fMRI) [ Time Frame: Change in connectivity measurements between baseline and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	June 2011
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Groups/Cohorts

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	55 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603771

Contacts

Contact: Jennifer Johanning, MPH

(314)286-2716

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Ellen F. Binder, MD

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator:

Ellen F. Binder, MD

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01603771 History of Changes
Other Study ID Numbers:	201104290, 7432-01
Study First Received:	May 2, 2012
Last Updated:	May 18, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

Adult
Exercise
Cognition
MRI

ClinicalTrials.gov processed this record on May 22, 2013

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