AgingNCT01038726
Effects of Exercise and Cognitive Training on Cognitive Function in Older Adults
A study testing Exercise Training, Cognitive Training and Flexibility Training in people with Aging and Alzheimer's Disease, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to gain a better understanding of the effects of exercise and cognitive training on improving brain function in healthy older adults who may be at risk for developing Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Alzheimer's Disease
- What is being tested?
- Exercise Training, Cognitive Training and Flexibility Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Sep 2012
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First or Second-degree relative of someone with Alzheimer's Disease
- Not currently engaging in regular exercise
- Able to undergo an MRI
- Fluent in English
Who cannot join
- Neurological illnesses/conditions
- Medical illness/conditions that may affect brain function
- Any unstable or severe cardiovascular disease or asthmatic condition
- Severe depressive symptoms
- Inability to walk unassisted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neural Effects of Exercise, Cognitive, or Combined Training in AD At-Risk Elders
The purpose of this study is to gain a better understanding of the effects of exercise and cognitive training on improving brain function in healthy older adults who may be at risk for developing Alzheimer's Disease.
- Conditions
- Aging, Alzheimer's Disease
- Being tested
- Exercise Training, Cognitive Training, Flexibility Training, Educational Sessions
- Keywords
- Healthy Aging
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
Aerobic exercise training program designed by the Cardiac Rehabilitation department
Cognitive TrainingOther
Based on cognitive training program Brain Fitness®
Flexibility TrainingOther
Non-aerobic flexibility training program designed by the Cardiac Rehabilitation department
Educational SessionsOther
DVD-based educational programs on history, art, and literature
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training | Active comparator | Not described Receives: Other: Exercise Training |
| Combined Cognitive/Exercise Training | Active comparator | Not described Receives: Other: Exercise Training; Other: Cognitive Training |
| Cognitive Training | Active comparator | Not described Receives: Other: Cognitive Training |
| Combined Low Intensity Training | Active comparator | Not described Receives: Other: Flexibility Training; Other: Educational Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation patterns measured by functional MRI
Measured: baseline and 12 weeks
Secondary outcomes (2)
Neuropsychological Testing
Measured: baseline and 12 weeks
Exercise assessment
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Stephen M Rao, Ph.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038726
- Sponsor's protocol ID
- NIH AG035775-01
- Status last verified
- Sep 2013
- First submitted
- 21 Dec 2009
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Effects of Exercise, Cognitive, or Combined Training in AD At-Risk Elders
- ClinicalTrials.gov ID
- NCT01038726
- Acronym / sponsor ID
- NIH AG035775-01
- Conditions
- Aging, Alzheimer's Disease
- Keywords
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Dec 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 24 Dec 2009 (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 purpose of this study is to gain a better understanding of the effects of exercise and cognitive training on improving brain function in healthy older adults who may be at risk for developing Alzheimer's Disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Active comparator | Other: Exercise Training |
| Combined Cognitive/Exercise Training | Active comparator | Other: Exercise Training, Other: Cognitive Training |
| Cognitive Training | Active comparator | Other: Cognitive Training |
| Combined Low Intensity Training | Active comparator | Other: Flexibility Training, Other: Educational Sessions |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First or Second-degree relative of someone with Alzheimer's Disease
- Not currently engaging in regular exercise
- Able to undergo an MRI
- Fluent in English
Key exclusion criteria (5 listed)
- Neurological illnesses/conditions
- Medical illness/conditions that may affect brain function
- Any unstable or severe cardiovascular disease or asthmatic condition
- Severe depressive symptoms
- Inability to walk unassisted
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 |
|---|---|---|
| Exercise TrainingAerobic exercise training program designed by the Cardiac Rehabilitation department | Other | Combined Cognitive/Exercise Training, Exercise Training |
| Cognitive TrainingBased on cognitive training program Brain Fitness® | Other | Cognitive Training, Combined Cognitive/Exercise Training |
| Flexibility TrainingNon-aerobic flexibility training program designed by the Cardiac Rehabilitation department | Other | Combined Low Intensity Training |
| Educational SessionsDVD-based educational programs on history, art, and literature | Other | Combined Low Intensity Training |
Primary outcome
Brain activation patterns measured by functional MRI
Time frame: baseline and 12 weeks
2 secondary outcomes
Neuropsychological Testing
Time frame: baseline and 12 weeks
Exercise assessment
Time frame: baseline and 12 weeks
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 18 Sep 2013.
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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.
Stephen M Rao, Ph.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training, Cognitive Training and Flexibility Training in people with Aging and Alzheimer's Disease, run by The Cleveland Clinic 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 4 inclusion and 5 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 18 Sep 2013. 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?
Brain activation patterns measured by functional MRI (time frame: baseline and 12 weeks). 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 18 Sep 2013.