Piedmont Aging, Cognition & Exercise Study-2

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Prediabetes

• Registration Number: NCT02312843
• Lead Sponsor: Wake Forest University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-09
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in cognitive performance from baseline following 6 month of high or low intensity exercise regimen	2 assessments, one before and one after 6 months of exercise	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.

Secondary Outcome Measures

Name	Time	Method
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	3 Oral glucose tolerance tests over a 6 month period; 2 lumbar punctures, one before and one after the 6 month exercise regimen	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.

Trial Locations

Locations (1)

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States