Neural ConnectivityNACNCT01603771
Neural Activation and Connectivity in Response to Exercise and Cognitive Training
An observational study of Neural Connectivity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Neural Connectivity
- What is being tested?
- Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI)
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- meet the inclusion criteria for the parent study, Combining Exercise and Cognitive Training to Improve Everyday Function (EXACT) study (Unique Protocol ID 201102416).
Who cannot join
- currently taking chronic psychotropic medication, beta blockers, or calcium channel blockers
- contraindication to MRI scanning
- inability to complete MRI scans in closed scanner
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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).
- Conditions
- Neural Connectivity
- Being tested
- Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI)
- Keywords
- Adult, Exercise, Cognition, MRI
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI) | |
| 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. Receives: Other: Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity of large-scale brain networks as seen through Blood Oxygen Level Dependent (BOLD) functional magnetic resonance imaging (fMRI)
Measured: Change in connectivity measurements between baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neural ConnectivityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen F. Binder, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603771
- Sponsor's protocol ID
- 201104290
- Other IDs
- 7432-01
- Acronym
- NAC
- Status last verified
- Aug 2014
- First submitted
- 2 May 2012
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Activation and Connectivity in Response to Exercise and Cognitive Training
- ClinicalTrials.gov ID
- NCT01603771
- Acronym / sponsor ID
- NAC / 201104290
- Conditions
- Neural Connectivity
- Keywords
- Adult, Exercise, Cognition, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined | – | Other: Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI)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. |
| Control | – | Other: Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI)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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- meet the inclusion criteria for the parent study, Combining Exercise and Cognitive Training to Improve Everyday Function (EXACT) study (Unique Protocol ID 201102416).
Key exclusion criteria (3 listed)
- currently taking chronic psychotropic medication, beta blockers, or calcium channel blockers
- contraindication to MRI scanning
- inability to complete MRI scans in closed scanner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Combined, Control |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen F. Binder, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neural Connectivity, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.