Trial record 1 of 4 for:    Cerebrovascular Dysfunction and Exercise Training
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Aerobic Exercise Training in Mild Cognitive Impairment Study (AETMCI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rong Zhang, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01146717
First received: June 16, 2010
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

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 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 and brain function in patients with mild cognitive impairment.


Condition Intervention Phase
Mild Cognitive Impairment
Behavioral: Exercise
Behavioral: Balance training
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mild Cognitive Impairment:Cerebrovascular Dysfunction and Exercise

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Cognitive function [ Time Frame: One year ] [ Designated as safety issue: No ]
    A comprehensive battery of neuropsychological tests focused on memory and executive function will be used to assess effects of exercise on cognitive function.


Secondary Outcome Measures:
  • Cerebrovascular function [ Time Frame: One year ] [ Designated as safety issue: No ]
    Transcranial Doppler and perfusion magnetic resonance imaging (MRI) will be used to measure cerebrovascular function/brain perfusion before and after exercise training.

  • Brain tissue volume and white matter integrity [ Time Frame: One year ] [ Designated as safety issue: No ]
    Magnetic resonance imaging (MRI) will be used to measure changes in brain volume and white matter integrity before and after exercise training.


Estimated Enrollment: 204
Study Start Date: March 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Behavioral: Exercise
Patients with mild cognitive impairment will undergo moderate intensity endurance exercise training for one year.
Placebo Comparator: Control group Behavioral: Balance training
A group of patients with mild cognitive impairment will perform flexibility and balance training for one year as a control group.

Detailed Description:

We plan to screen 144 patients with mild cognitive impairment and 60 control subjects in order to enroll 204 participants 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.

An overview of the Baseline study procedures is as follows:

  • Visit 1--Informed consent, medical history and physical examination,24 hour blood pressure, physical activity, quality of life questionnaires and Cognitive Evaluation. Texas Health Presbyterian Hospital Dallas IEEM. 2-3 hours.
  • Visit 2--Overview Day to discuss cognitive scoring, review ABPM and Actical results, Physical function, CHAMPS, Mold of cranial artery. Texas Health Presbyterian Hospital Dallas IEEM 2 hours.
  • Visit 3--Vascular function Texas Health Presbyterian Hospital Dallas IEEM. 3-4 hours.
  • Visit 4--Physical and exercise testing. Texas Health Presbyterian Hospital Dallas IEEM. 3-4 hours.
  • Visit 5--Dynamic and static cerebral auto-regulation. Texas Health Presbyterian Hospital Dallas IEEM. 3-4 hours.
  • Visit 6--Brain function tests. UTSW Clinical Neuro-psychology Laboratory. 2-3 hours
  • Visit 7--Dynamic and static cerebral auto-regulation with medication. Texas Health Presbyterian Hospital Dallas IEEM. 4 hours.

---------The last 2 visits are only for the Memory Impairment Group---------

  • Visit 8--Positron-Emission Tomography (PET) Scans. UTSW PET imaging Center. 1-2 hours
  • Visit 9--Exercise Training Day. Texas Health Presbyterian Hospital Dallas IEEM.1-2 hours.

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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 55-80 years old, Male or Female
  2. Control Subjects: absence of cognitive complaints and normal performance in Uniform Data Set (UDS) neuropsychological tests.
  3. For patients: Diagnosis of amnestic MCI (single and multiple domains) by Petersen's criteria (as modified for ADNI-GO study).
  4. Stable medical condition for > 6 months
  5. Sable medications for >2 months (use of cholinesterase inhibitors, or prior use of multivitamins is allowed)
  6. Caregiver/informant available to accompany patient for scheduled visits in case the patient develops cognitive impairment that interferes with independent study participation.
  7. Fluency of patient and caregiver in English
  8. Ability to return to clinic for additional visits over a 12 month period.
  9. ≥ 10 years of education or enough work history to exclude mental retardation.
  10. Adequate visual and auditory acuity to allow neuropsychological testing.
  11. Screening laboratory tests and ECG without significant abnormalities that might interfere with the study.
  12. Physical ability to undergo endurance exercise training.

Exclusion Criteria:

  1. Diagnosis of Alzheimer's Disease or other type of dementia.
  2. Participant enrolled in any other investigational drug study within 2 months or longer, depending on the investigational drug half-life.
  3. Modified Hachinski Score ≥ 4.
  4. Subject has history in the past 2 years of epileptic seizures, or DSM-IV criteria of any major psychiatric disorders.
  5. Past history or MRI evidence of brain damage including significant trauma, stroke, hydrocephalus, mental retardation or serious neurological disorder.
  6. Carotid stent or sever stenosis.
  7. Significant history of active alcoholism or drug abuse.
  8. History of myocardial infarction within the previous year. Unstable cardiac, renal, lung, liver or other severe chronic diseases.
  9. Uncontrolled hypertension (Systolic Blood Pressure (SBP) ≥160, Diastolic Blood Pressure (DBP) ≥100)or hypotension (SBP <100 mmHg).
  10. Currently diagnosed and being treated for Diabetes Mellitus (DM).
  11. Obesity with Body Mass Index (BMI) ≥ 35.
  12. History of familial early onset (<55 years old) dementia
  13. Pacemaker or other medical device of metal that precludes performing MRI.
  14. Subjects who have been engaged in moderate intensity aerobic exercise training for > 30 minutes, 3 times per week over the past 2 years.
  15. History of a clinical diagnosis of B12 deficiency or hypothyroidism. (stable treatment for at least 3 months is allowed).
  16. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146717

Contacts
Contact: Candace Hill, BSN 214.345.4665 CandaceHill@TexasHealth.org

Locations
United States, Texas
UT Southwestern ADC/Institute for Exercise and Environmental Medicine Recruiting
Dallas, Texas, United States, 75231
Contact: Candace Hill, BSN    214-345-4665    CandaceHill@texashealth.org   
Principal Investigator: Rong Zhang, PhD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Rong Zhang, PhD UTSW
  More Information

No publications provided

Responsible Party: Rong Zhang, Dr. Rong Zhang, UTSW, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01146717     History of Changes
Other Study ID Numbers: 032009-065, R01AG033106-01A2
Study First Received: June 16, 2010
Last Updated: June 25, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Mild Cognitive Impairment
Exercise

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014