Mild Cognitive ImpairmentAETMCINCT01146717
Aerobic Exercise Training in Mild Cognitive Impairment Study
A study testing Exercise and Balance training in people with Mild Cognitive Impairment, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study is being done to find out whether regulation of brain blood flow is altered in patents with mild cognitive impairment (those who have memory problems but otherwise healthy) when compared with healthy elderly individuals. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Exercise and Balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2016
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55-80 years old, Male or Female
- Control Subjects: absence of cognitive complaints and normal performance in Uniform Data Set (UDS) neuropsychological tests.
- For patients: Diagnosis of amnestic MCI (single and multiple domains) by Petersen's criteria (as modified for ADNI-GO study).
- Stable medical condition for > 6 months
- Sable medications for >2 months (use of cholinesterase inhibitors, or prior use of multivitamins is allowed)
- Caregiver/informant available to accompany patient for scheduled visits in case the patient develops cognitive impairment that interferes with independent study participation.
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- Fluency of patient and caregiver in English
- Ability to return to clinic for additional visits over a 12 month period.
- ≥ 10 years of education or enough work history to exclude mental retardation.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Screening laboratory tests and ECG without significant abnormalities that might interfere with the study.
- Physical ability to undergo endurance exercise training.
Who cannot join
- Diagnosis of Alzheimer's Disease or other type of dementia.
- Participant enrolled in any other investigational drug study within 2 months or longer, depending on the investigational drug half-life.
- Modified Hachinski Score ≥ 4.
- Subject has history in the past 2 years of epileptic seizures, or DSM-IV criteria of any major psychiatric disorders.
- Past history or MRI evidence of brain damage including significant trauma, stroke, hydrocephalus, mental retardation or serious neurological disorder.
- Carotid stent or sever stenosis.
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- Significant history of active alcoholism or drug abuse.
- History of myocardial infarction within the previous year. Unstable cardiac, renal, lung, liver or other severe chronic diseases.
- Uncontrolled hypertension (Systolic Blood Pressure (SBP) ≥160, Diastolic Blood Pressure (DBP) ≥100)or hypotension (SBP <100 mmHg).
- Currently diagnosed and being treated for Diabetes Mellitus (DM).
- Obesity with Body Mass Index (BMI) ≥ 35.
- History of familial early onset (<55 years old) dementia
- Pacemaker or other medical device of metal that precludes performing MRI.
- Subjects who have been engaged in moderate intensity aerobic exercise training for > 30 minutes, 3 times per week over the past 2 years.
- History of a clinical diagnosis of B12 deficiency or hypothyroidism. (stable treatment for at least 3 months is allowed).
- Chronic inflammatory diseases including, lupus, rheumatoid arthritis and polymyalgia rheumatica.
- Prohibited Medications:
- narcotics
- anti-Parkinsonian medications
- anti-convulsants for treatment of seizure disorder
- drugs that can influence psychometric test results.
- Subjects on a statins or non-steroidal anti-inflammatory drug (NSAID) are eligible but must be on a stable dose for at least 2 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern ADC/Institute for Exercise and Environmental Medicine
Dallas, Texas, 75231
About this study
Official title: Mild Cognitive Impairment:Cerebrovascular Dysfunction and Exercise
This study is being done to find out whether regulation of brain blood flow is altered in patents with mild cognitive impairment (those who have memory problems but otherwise healthy) when compared with healthy elderly individuals. In addition, this study will determine whether exercise training improves brain blood flow, brain structure, and brain function in patients with mild cognitive impairment (MCI).
This is a research study because at present the investigators know little about brain blood flow regulation in patients with mild cognitive impairment. The investigators also know little about whether exercise training improves brain blood flow, brain structure, and brain function in patients with mild cognitive impairment.
Read the detailed description
We plan to study 70 patients with amnestic MCI and 30 healthy older adults with similar age, sex, and educational level in this research at the University of Texas Southwestern(UTSW) Medical Center Dallas and Texas Health Presbyterian Hospital Dallas - Institute for Exercise an Environmental Medicine (IEEM).
To help decide if you qualify to be in this study, the researchers may ask you questions about your health, including medications you take and any surgical procedures you have had. You may also have to fill out certain forms or have the following exams, tests or procedures. The screening process usually takes 2-3 hours.
You will be required to come for 7-9 visits including the initial screening for eligibility to participate in this study. The experiments will measure your brain perfusion, vascular function and exercise capacity.
For the healthy controls, the expected length of this study will be about 2-3 months including all the test visits. Your participation in this study will end following completion of your testing.
For those with Mild Cognitive Impairment, the expected length of this study will be about 18 months including all the test visits and exercise training. Your participation in this study will end following completion of your repeat testing after one-year exercise training or control intervention. On occasion, training may be delayed due to injury, illness or personal matters. If this is the case, your enrollment in the study may last longer than one year as we attempt to complete the training and testing.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Exercise, Balance training
- Keywords
- Mild Cognitive Impairment, Exercise
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Patients with mild cognitive impairment will undergo moderate intensity endurance exercise training for one year.
Balance trainingBehavioural
A group of patients with mild cognitive impairment will perform flexibility and balance training for one year as a control group.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Behavioral: Exercise |
| Control group | Placebo comparator | Not described Receives: Behavioral: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
A comprehensive battery of neuropsychological tests focused on memory and executive function will be used to assess effects of exercise on cognitive function.
Measured: One year
Secondary outcomes (2)
Cerebrovascular function
Transcranial Doppler and perfusion magnetic resonance imaging (MRI) will be used to measure cerebrovascular function/brain perfusion before and after exercise training.
Measured: One year
Brain tissue volume and white matter integrity
Magnetic resonance imaging (MRI) will be used to measure changes in brain volume and white matter integrity before and after exercise training.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Rong Zhang, University of Texas Southwestern Medical Center
- Investigators
- Rong Zhang, PhD, Principal investigator, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146717
- Sponsor's protocol ID
- 032009-065
- Other IDs
- R01AG033106-01A2
- Acronym
- AETMCI
- Status last verified
- Oct 2016
- First submitted
- 16 Jun 2010
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sugawara J, Tarumi T, Tomoto T, Pasha E, Cullum CM, Zhang R. Exercise Training Reduces Cerebrovascular Impedance in Patients with Amnestic Mild Cognitive Impairment: A 1-Year Randomized Controlled Trial. Med Sci Sports Exerc. 2026 May 1;58(5):1021-1034. doi: 10.1249/MSS.0000000000003935. Epub 2026 Jan 26.
PubMed 41538307Pasha EP, Rutjes E, Tomoto T, Tarumi T, Stowe A, Claassen JAHR, Munro Cullum C, Zhu DC, Zhang R. Carotid Stiffness is Associated with Brain Amyloid-beta Burden in Amnestic Mild Cognitive Impairment. J Alzheimers Dis. 2020;74(3):925-935. doi: 10.3233/JAD-191073.
PubMed 32083583Stowe AM, Ireland SJ, Ortega SB, Chen D, Huebinger RM, Tarumi T, Harris TS, Cullum CM, Rosenberg R, Monson NL, Zhang R. Adaptive lymphocyte profiles correlate to brain Abeta burden in patients with mild cognitive impairment. J Neuroinflammation. 2017 Jul 27;14(1):149. doi: 10.1186/s12974-017-0910-x.
PubMed 28750671
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Cognitive Impairment:Cerebrovascular Dysfunction and Exercise
- ClinicalTrials.gov ID
- NCT01146717
- Acronym / sponsor ID
- AETMCI / 032009-065
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Mar 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Jun 2010 (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.
This study is being done to find out whether regulation of brain blood flow is altered in patents with mild cognitive impairment (those who have memory problems but otherwise healthy) when compared with healthy elderly individuals. In addition, this study will determine whether exercise training improves brain blood flow, brain structure, and brain function in patients with mild cognitive impairment (MCI).
This is a research study because at present the investigators know little about brain blood flow regulation in patients with mild cognitive impairment. The investigators also know little about whether exercise training improves brain blood flow, brain structure, and brain function in patients with mild cognitive impairment.
Detailed description
We plan to study 70 patients with amnestic MCI and 30 healthy older adults with similar age, sex, and educational level in this research at the University of Texas Southwestern(UTSW) Medical Center Dallas and Texas Health Presbyterian Hospital Dallas - Institute for Exercise an Environmental Medicine (IEEM).
To help decide if you qualify to be in this study, the researchers may ask you questions about your health, including medications you take and any surgical procedures you have had. You may also have to fill out certain forms or have the following exams, tests or procedures. The screening process usually takes 2-3 hours.
You will be required to come for 7-9 visits including the initial screening for eligibility to participate in this study. The experiments will measure your brain perfusion, vascular function and exercise capacity.
For the healthy controls, the expected length of this study will be about 2-3 months including all the test visits. Your participation in this study will end following completion of your testing.
For those with Mild Cognitive Impairment, the expected length of this study will be about 18 months including all the test visits and exercise training. Your participation in this study will end following completion of your repeat testing after one-year exercise training or control intervention. On occasion, training may be delayed due to injury, illness or personal matters. If this is the case, your enrollment in the study may last longer than one year as we attempt to complete the training and testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise |
| Control group | Placebo comparator | Behavioral: Balance training |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 55-80 years old, Male or Female
- Control Subjects: absence of cognitive complaints and normal performance in Uniform Data Set (UDS) neuropsychological tests.
- For patients: Diagnosis of amnestic MCI (single and multiple domains) by Petersen's criteria (as modified for ADNI-GO study).
- Stable medical condition for > 6 months
- Sable medications for >2 months (use of cholinesterase inhibitors, or prior use of multivitamins is allowed)
Key exclusion criteria (22 listed)
- Diagnosis of Alzheimer's Disease or other type of dementia.
- Participant enrolled in any other investigational drug study within 2 months or longer, depending on the investigational drug half-life.
- Modified Hachinski Score ≥ 4.
- Subject has history in the past 2 years of epileptic seizures, or DSM-IV criteria of any major psychiatric disorders.
- Past history or MRI evidence of brain damage including significant trauma, stroke, hydrocephalus, mental retardation or serious neurological disorder.
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 |
|---|---|---|
| ExercisePatients with mild cognitive impairment will undergo moderate intensity endurance exercise training for one year. | Behavioural | Exercise |
| Balance trainingA group of patients with mild cognitive impairment will perform flexibility and balance training for one year as a control group. | Behavioural | Control group |
Primary outcome
Cognitive function
Time frame: One year
A comprehensive battery of neuropsychological tests focused on memory and executive function will be used to assess effects of exercise on cognitive function.
2 secondary outcomes
Cerebrovascular function
Time frame: One year
Brain tissue volume and white matter integrity
Time frame: One year
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 7 Feb 2020.
- Derived from this study: PubMed 41538307Sugawara J, Tarumi T, Tomoto T, Pasha E, Cullum CM, Zhang R. Exercise Training Reduces Cerebrovascular Impedance in Patients with Amnestic Mild Cognitive Impairment: A 1-Year Randomized Controlled Trial. Med Sci Sports Exerc. 2026 May 1;58(5):1021-1034. doi: 10.1249/MSS.0000000000003935. Epub 2026 Jan 26.
- Derived from this study: PubMed 32083583Pasha EP, Rutjes E, Tomoto T, Tarumi T, Stowe A, Claassen JAHR, Munro Cullum C, Zhu DC, Zhang R. Carotid Stiffness is Associated with Brain Amyloid-beta Burden in Amnestic Mild Cognitive Impairment. J Alzheimers Dis. 2020;74(3):925-935. doi: 10.3233/JAD-191073.
- Derived from this study: PubMed 28750671Stowe AM, Ireland SJ, Ortega SB, Chen D, Huebinger RM, Tarumi T, Harris TS, Cullum CM, Rosenberg R, Monson NL, Zhang R. Adaptive lymphocyte profiles correlate to brain Abeta burden in patients with mild cognitive impairment. J Neuroinflammation. 2017 Jul 27;14(1):149. doi: 10.1186/s12974-017-0910-x.
- Related InfoLink provided by the sponsor.
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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.
Rong Zhang, PhD principal investigator
UTSW
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 and Balance training in people with Mild Cognitive Impairment, run by University of Texas Southwestern Medical Center 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 12 inclusion and 22 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 7 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
Cognitive function (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01146717, which also lists 3 linked publications.
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 7 Feb 2020.