Piedmont Aging, Cognition & Exercise Study-2

Mild Cognitive Impairment Clinical Trial

— PACE-2  

Official title:

A Randomized Controlled Trial to Examine the Effects of Aerobic Exercise on Cognition and Aging-related Biomarkers for Adults With Prediabetes and Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312843
• Other study ID #: IRB00022598
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: April 2017

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to examine the effects of high and low intensity exercise for those with mild memory loss and pre-diabetes. The investigators will also examine the effects of this exercise on certain proteins and hormones in body fluids, and on brain structure and function using magnetic resonance imaging (MRI). Recent studies indicate that exercise improves memory and thinking abilities for adults with mild memory loss OR pre-diabetes. This study examines the effects of exercise on people with mild memory loss AND pre-diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 89 Years

Eligibility

Inclusion Criteria:

• 50 years or older

• Mild memory concerns

• In good health

• Not taking diabetes medications

• Not currently exercising

Exclusion Criteria:

• Significant neurologic disease that might affect cognition, such as AD, stroke, Parkinson's disease, multiple sclerosis, or severe head injury with loss of consciousness > 30 min or with permanent neurologic sequelae;

• Significant medical illness or organ failure, such as:

• Liver disease: history of hepatitis or hepatic failure

• Significant elevations in liver function tests: lab values more than 2.5 times the upper limit of normal

• Kidney disease known history of kidney failure.

• Uncontrolled hypertension

• Cardiovascular disease, defined as: any acute cardiovascular abnormality, such as new or unstable angina, uncontrolled irregular heart beat (treated a-fib and occasional PVC's are OK) or symptomatic heart failure, acute shortness of breath for any reason, or clinically significant edema, is an exclusion. History in the last year of myocardial infarction, angina, coronary artery angioplasty, bypass grafting, pacemaker insertion, STENT placement, postural hypotension, transient ischemic attack, or carotid artery surgery.

• Chronic lung disease, such as: COPD/emphysema

• Hemoglobin A1c levels that fall outside the range of 5.7-6.4%; If 2-h OGTT glucose values 220 mg/dL and hemoglobin A1c levels meet inclusion criteria (5.7-6.4%), then PCP written indication that no pharmacologic intervention for type 2 diabetes is needed at present will be required for continued study participation.

• Current use of anti-psychotic, anti-convulsant, anxiolytic, or sedative medication;

• Current use of any cognition-enhancing medication, including experimental medications within the past 60 days;

• Current or previous use of hypoglycemic agents or insulin (except during pregnacy); diabetics previously on oral agents but have been off of them for > 1 year are ok pending PI and study physician approval.

• Musculoskeletal impairment sufficient to interfere with study participation

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Glucose Intolerance
• Mild Cognitive Impairment
• Prediabetes
• Prediabetic State

Intervention

Behavioral:
• Exercise/Aerobic

• Exercise/Stretching

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in brain network connectivity using brain imaging	Whole-brain averages will be computed, reflecting characteristics of the entire system. Whole-brain averages will be compared with random networks generated with the same node number and degree,48 and will be compared between intervention groups using general linear regression models. Regions of interest (hippocampus, posterior cingulate/precuneus, prefrontal cortex) will be extracted using WFU Pickatlas and regional degree, Eglob, or Eloc will be compared between groups using the general linear model.	2 brain scans over a 6 month period, one before and one after the 6 month exercise regimen
Primary	Change in cognitive performance from baseline following 6 month of high or low intensity exercise regimen	The cognitive variables identified above, by domain, will be subjected to separate treatment group X treatment month (3, 6) multivariate analyses of covariance (MANCOVA), with baseline scores and age serving as covariates. When the MANCOVA proves significant, separate post-hoc analysis of covariance (ANCOVA) will be conducted on the relevant dependent variables.; Cognitive tests include measures of executive function and working memory.	2 assessments, one before and one after 6 months of exercise
Secondary	Change from baseline in blood sugar concentration and cerebrospinal fluid glucose measures during an oral glucose tolerance test following 6 months of high or low intensity exercise	Multiple regression and correlational (MRC) analyses will be conducted to evaluate whether treatment-induced change in insulin sensitivity and in other blood and cerebrospinal fluid biomarkers predict cognitive performance among subjects in the aerobic group.	3 Oral glucose tolerance tests over a 6 month period; 2 lumbar punctures, one before and one after the 6 month exercise regimen