Aerobic Exercise Training in Mild Cognitive Impairment Study

NCT01146717 | Completed DMC

• 2 other identifiers: 032009-065R01AG033106-01A2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment; Exercise

Outcome Measures

Primary Outcomes (1)

• 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.

  One year

Secondary Outcomes (2)

• Cerebrovascular function

  One year

• Brain tissue volume and white matter integrity

  One year

Study Arms (2)

Exercise

EXPERIMENTAL

Behavioral: Exercise

Control group

PLACEBO COMPARATOR

Behavioral: Balance training

Interventions

Exercise BEHAVIORAL

Patients with mild cognitive impairment will undergo moderate intensity endurance exercise training for one year.

Exercise

Balance training BEHAVIORAL

A group of patients with mild cognitive impairment will perform flexibility and balance training for one year as a control group.

Control group

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UT Southwestern ADC/Institute for Exercise and Environmental Medicine

Dallas, Texas, 75231, United States

Location

Related Publications (2)

• Pasha 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.

  PMID: 32083583 DERIVED

• Stowe 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.

  PMID: 28750671 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rong Zhang, PhD

  UTSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Rong Zhang, UTSW

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 17, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 7, 2020

Record last verified: 2016-10

Locations

US (1)