Piedmont Aging, Cognition & Exercise Study-2

NCT02312843 | Completed

• 1 other identifier: IRB00022598
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Prediabetes

Keywords

Mild Cognitive Impairment; Cognitive disorders; Prediabetes; Exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• Change from baseline in brain network connectivity using brain imaging

  2 brain scans over a 6 month period, one before and one after the 6 month exercise regimen

Study Arms (2)

High-Intensity Program-aerobic exercises

ACTIVE COMPARATOR

This exercise program will consist of walking or running on a treadmill or elliptical trainer, or spinning on a stationary bicycle. The goal of the program will be for participants to exercise at a moderate to high level of intensity, defined as 70-80% (American College of Sports Medicine guidelines) of heart rate reserve (HRR), for 45-60 minutes 4 days per week. At the start of each training session and following a 5-minute warm-up, subjects will exercise at 50% HRR (0.5\[HRmax-HRrest\] +HRrest) and intensity will gradually be increased to the individualized target heart rate training zone. Exercise facilitators will use a pre-specified computerized program. This program provides guidelines for the individualized progression of exercise based on age and resting heart rate. Subjects will wear a digital heart rate monitoring device for the duration of the training session to ensure they are exercising safely at the specified level of intensity.

Behavioral: Exercise/Aerobic

Low-intensity Program-Stretching

PLACEBO COMPARATOR

The low-intensity activity program will consist of an individualized and organized series of stretching and balance activities for the whole body, specifically designed for older adults. Consistent with the high-intensity protocol, subjects will complete the prescribed 45-60 minute stretching routine 4 days per week at the exercise facility. All stretching routines will include warm-up and cool-down activities, and will be within each subject's range of motion. Each stretch will be held for 20-30 s and repeated 5-10 times. Subjects will wear a digital heart rate monitoring device to ensure they are stretching safely and at an intensity below 35% HRR. The activity log completed during each stretching session will include HR, stretching duration, and mean HR during stretching. Subjects will also have the option to participate in structured pre-approved (by the exercise facilitator) stretching classes at the exercise facility when available.

Behavioral: Exercise/Stretching

Interventions

Exercise/Aerobic BEHAVIORAL

High-Intensity Program-aerobic exercises

Exercise/Stretching BEHAVIORAL

Low-intensity Program-Stretching

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Mild memory concerns
• In good health
• Not taking diabetes medications
• Not currently exercising

You may not qualify if:

• 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
• Chronic lung disease, such as: COPD/emphysema
• 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

Sponsors & Collaborators

• Wake Forest University: lead
• American Diabetes Association: collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Prediabetic State; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Laura D. Baker, Ph.D

  Wake Forest University Health Sciences

  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: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: December 9, 2014
• Study Start: March 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)