Back to results

Reducing African American's Alzheimer's Risk Through Exercise-Mild Cognitive Impairment (RAATE-MCI) (RAATE-MCI)

Primary Purpose

Dementia of Alzheimer Type

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical activity program

Successful Aging

About this trial

This is an interventional prevention trial for Dementia of Alzheimer Type

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

are African American (self-identify)
are 60 and older
are physically capable of exercise
are willing to accept randomization
are willing to attend group sessions
plan to live in the study area over the next 13 months and capable of traveling to designated study facility for clinic visits and intervention sessions for the next year
are free of conditions (e.g. uncontrolled asthma, severe sickle cell disease, etc.) that would make regular exercise unsafe as deemed by the medical investigator
have not engaged in regular physical activity
have a Short Physical Performance Battery ≥4
physically capable of exercise
are unable to utilize devices and/or applications as required for study participation
willing to attend group sessions
willing to allow researchers to use data for research purposes after study participation is completed
meet criteria for MCI as defined by the NIA-AA research framework a. cognitive performance below normal range (score < 1.5 SDs below the mean on NIH Toolbox scores for their age and sex on at least one of the subtests)

Exclusion Criteria:

have cognitive impairment that would interfere with participating in a group discussion
a. cognitive performance in the demented range (score < 3 SDs below the mean on NIH Toolbox scores for their age and sex on at least one of the subtests)
meet criteria for dementia
are unwilling to give written informed consent or accept randomization in either study group
are too active (as defined by ≥10 min bouts of MVPA as measured by Actigraph) if:
1. Sum of MVPA bouts for the 7 day wear period ≥40 mins
2. Or ≤40 mins of MVPA 10min bouts AND ≥3 days of bouts
have uncontrolled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg).
have had a myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis, pulmonary embolus, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
are undergoing cardiopulmonary rehabilitation
have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
have clinically diagnosed osteoporosis that in the judgment of the MI may interfere with study participation
are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
have another member of the household that is a participant in RAATE or RAATE MCI
refuse to participate in the study without disclosure of their amyloid PET scan results
refuse to allow anonymized versions of their study data for research after this study is completed.
have other medical, psychiatric, or behavioral factors that in the judgment of the Principal or Medical Investigator may interfere with study participation or the ability to follow the intervention protocol

Sites / Locations

Pennington Biomedical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Physical Activity

Successful Aging

Arm Description

150 minutes of physical activity weekly

Low intensity activity program and a healthy aging educational component

Outcomes

Primary Outcome Measures

Change in executive function

The primary outcome measure will be executive function measured by the NIH-Toolbox Cognitive Battery. The NIH Toolbox Executive Function subdomain consists of the Flanker Inhibitory Control and Attention Test and the Dimensional Change Card Sort Test. The Flanker test is a measure of one's ability to inhibit attention to irrelevant conditions. Participants must identify the direction of a central visual stimuli amongst flanking stimuli either congruent or incongruent with the central stimuli. There are 40 trials and scores range from 0 - 10. The Card Sort is a measure of the ability to shift attention based on rules. Participants must match a target visual stimuli to either a color or word stimuli and this matching shifts during the assessment.

Change in episodic memory

The Rey Auditory Verbal Learning Test (RAVLT) is a common neuropsychological tool used to evaluate episodic memory. The RAVLT involves providing participants with 15 unrelated words and asking them to recall the word list. There are 5 trials designed to determine short-term memory and then a 30 minute delay to assess long-term memory. The total words correct in both the short- and long-term trials are used as outcome measures.

Secondary Outcome Measures

Change in cognitive status

The Mini-Mental Status Examination is 30-point questionnaire to assess cognitive impairment.

Change in glucose

Fasting levels of glucose will be assessed using standard assays.

Change in time spent in physical activity

The Actigraph WGT3X+ accelerometer (ActiGraph LLC, Pensacola, FL) will be worn by the participant for a 7-day period. The device provides both the number of steps per day as well as time in sedentary, light, moderate, and vigorous activity in 1-minute epochs (for adults) using the default filter.

Change in cardiorespiratory fitness

All participants will perform a standardized graded exercise testing protocol administered on a treadmill. Fitness will be measured in terms of mL oxygen/kg/min.

Change in physical function-NIH Toolbox

Physical function will be assessed using the NIH-TB Motor assessment, which assesses dexterity, balance, locomotion, grip strength, and strength.

Change in telomere length

DNA will be extracted from the blood draw and amplified using real-time quantitative polymerase chain reaction (qPCR) to determine average relative telomere length represented by the telomere repeat copy number to single gene copy number (T/S) ratio in triplicate as previously described

Change in weight

Weight will be measured using a standard stadiometer. Measurements will be taken to the nearest cm.

Change in brain structure

Volumes of the cranial vault, brain tissue, gray matter, white matter, and cerebrospinal fluid, which will be provided as the primary brain structural outcome measures of interest from MRI.

Changes in brain function

Pre-selected inhibitory control ROIs (ACC for the Stroop; DLPFC, thalamus, superior frontal, inferior frontal, fusiform, and middle frontal gyri; and ACC and middle frontal gyri for the ANT) are of primary interest.

Change in lipoproteins

Fasting levels of lipids will be assessed using standard assays.

APOE genotype

APOE genotype will be assessed using standard assays.

Change in physical activity

The Fitbit Charge 2 will be worn by participants in both groups.

Change in systolic blood pressure

Systolic blood pressure will be measured using the Omron, Model BP710 automatic blood pressure cuff.

Change in diastolic blood pressure

Diastolic blood pressure (both systolic and diastolic) will be measured using the Omron, Model BP710 automatic blood pressure cuff.

Change in mood

The Geriatric Depression Scale will be used to measure depressive symptoms.

Change in height

Height will be assessed using a standard stadiometer.

Change in physical function-SPPB

Physical function will be assessed using the the Short Physical Performance Battery (SPPB), which is a brief performance battery based on timed short distance walk, repeated chair stands and balance test.

Full Information

NCT ID

NCT04956549

First Posted

June 30, 2021

Last Updated

January 28, 2023

Sponsor

Pennington Biomedical Research Center

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04956549

Brief Title

Reducing African American's Alzheimer's Risk Through Exercise-Mild Cognitive Impairment (RAATE-MCI)

Acronym

RAATE-MCI

Official Title

Reducing African Americans' Alzheimer's Disease Risk Through Exercise-Mild Cognitive Impairment Cohort

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pennington Biomedical Research Center

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The RAATE-MCI proposal is designed to determine the effects of physical activity on risk factors for Alzheimer's Disease in older African American adults. The study will compare a physical activity program to an active control group. RAATE-MCI is a 52-week randomized controlled trial. 144 African American adults aged 60 and older will be recruited.

Detailed Description

Regular physical activity has proven to be a safe and effective means to enhance cognitive function in older adults ranging from cognitively healthy to mildly cognitively impaired. A large body of existing data suggests that exercise improves cardiovascular and cerebrovascular functioning and thus has the potential to enhance perivascular clearance of amyloid and reduce chronic brain tissue ischemia, among other beneficial effects. Therefore, our study is focused on physical activity promotion, a potent approach to modifying multiple neurobiological pathways implicated in Alzheimer's Disease. RAATE-MCI is a 52-week randomized controlled trial that will assign insufficiently active African American adults aged 60 and older to one of two groups: a physical activity intervention or a successful aging (active control) group. Outcome measures will be collected at baseline, 24-,and 52-weeks. 144 older African American adults will be recruited. Intervention will consist of one of two groups: a 150 minutes of physical activity (PA) per week or successful aging (SA) group. All physical activity and successful aging group sessions will be conducted at Pennington Biomedical or at local community facilities that include branches of the YMCA and community centers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dementia of Alzheimer Type

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physical Activity

Arm Type

Experimental

Arm Description

150 minutes of physical activity weekly

Arm Title

Successful Aging

Arm Type

Experimental

Arm Description

Low intensity activity program and a healthy aging educational component

Intervention Type

Behavioral

Intervention Name(s)

Physical activity program

Intervention Description

Supervised group sessions will be held twice per week for approximately 52 weeks. Each physical activity session will last slightly approximately 80 minutes and will consist of aerobic, strength, flexibility, and balance training. The 80 minutes of activity consists of a 5 minute warm-up, 45 minutes of aerobic training, 15 minutes of strength training, 10 minutes of balance training, and a 5 minute cool-down. The physical activity group will target 150 minutes of moderate to vigorous aerobic physical activity and two days of strength training, consistent with the current physical activity recommendations.

Intervention Type

Behavioral

Intervention Name(s)

Successful Aging

Other Intervention Name(s)

active control

Intervention Description

The successful aging group will be based on a low-intensity activity program and a healthy aging educational component. Sessions will be approximately 60 minutes in duration and will occur once per week for the first 6 months and then every other week for the remainder 6 months of the study. The physical activities will include stretching, balance training, flexibility, relaxation, and practicing activities of daily living. The successful aging education component will cover topics including avoiding scams, fall prevention, living wills, and dementia awareness.

Primary Outcome Measure Information:

Title

Change in executive function

Description

Time Frame

Baseline, 24 weeks, 52 weeks

Title

Change in episodic memory

Description

Time Frame

Baseline, 24 weeks, 52 weeks

Secondary Outcome Measure Information:

Title

Change in cognitive status

Description

The Mini-Mental Status Examination is 30-point questionnaire to assess cognitive impairment.

Time Frame

Baseline, 24 weeks, 52 weeks

Title

Change in glucose

Description

Fasting levels of glucose will be assessed using standard assays.

Time Frame

Baseline, 24 weeks, 52 weeks

Title

Change in time spent in physical activity

Description

Time Frame

Baseline, 24 weeks, 52 weeks

Title

Change in cardiorespiratory fitness

Description

All participants will perform a standardized graded exercise testing protocol administered on a treadmill. Fitness will be measured in terms of mL oxygen/kg/min.

Time Frame

Baseline, 24 weeks, 52 weeks

Title

Change in physical function-NIH Toolbox

Description

Physical function will be assessed using the NIH-TB Motor assessment, which assesses dexterity, balance, locomotion, grip strength, and strength.

Time Frame

Baseline, 24 weeks, 52 weeks

Title

Change in telomere length

Description

Time Frame

Baseline, 24 weeks, 52 weeks

Title

Change in weight

Description

Weight will be measured using a standard stadiometer. Measurements will be taken to the nearest cm.

Time Frame

Baseline, 24 weeks, 52 weeks

Title

Change in brain structure

Description

Volumes of the cranial vault, brain tissue, gray matter, white matter, and cerebrospinal fluid, which will be provided as the primary brain structural outcome measures of interest from MRI.

Time Frame

Baseline, 24 weeks, 52 weeks

Title

Changes in brain function

Description

Time Frame

Baseline, 24 weeks, 52 weeks

Title

Change in lipoproteins

Description

Fasting levels of lipids will be assessed using standard assays.

Time Frame

Baseline, 24 weeks, 52 weeks

Title

APOE genotype

Description

APOE genotype will be assessed using standard assays.

Time Frame

Baseline

Title

Change in physical activity

Description

The Fitbit Charge 2 will be worn by participants in both groups.

Time Frame

Continuously for 52 weeks

Title

Change in systolic blood pressure

Description

Systolic blood pressure will be measured using the Omron, Model BP710 automatic blood pressure cuff.

Time Frame

SV, 26 weeks, 52 weeks

Title

Change in diastolic blood pressure

Description

Diastolic blood pressure (both systolic and diastolic) will be measured using the Omron, Model BP710 automatic blood pressure cuff.

Time Frame

SV, 26 weeks, 52 weeks

Title

Change in mood

Description

The Geriatric Depression Scale will be used to measure depressive symptoms.

Time Frame

Baseline, 24 weeks, 52 weeks

Title

Change in height

Description

Height will be assessed using a standard stadiometer.

Time Frame

Baseline, 24 weeks, 52 weeks

Title

Change in physical function-SPPB

Description

Time Frame

Baseline, 24 weeks, 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: are African American (self-identify) are 60 and older are physically capable of exercise are willing to accept randomization are willing to attend group sessions plan to live in the study area over the next 13 months and capable of traveling to designated study facility for clinic visits and intervention sessions for the next year are free of conditions (e.g. uncontrolled asthma, severe sickle cell disease, etc.) that would make regular exercise unsafe as deemed by the medical investigator have not engaged in regular physical activity have a Short Physical Performance Battery ≥4 physically capable of exercise are unable to utilize devices and/or applications as required for study participation willing to attend group sessions willing to allow researchers to use data for research purposes after study participation is completed meet criteria for MCI as defined by the NIA-AA research framework a. cognitive performance below normal range (score < 1.5 SDs below the mean on NIH Toolbox scores for their age and sex on at least one of the subtests) Exclusion Criteria: have cognitive impairment that would interfere with participating in a group discussion a. cognitive performance in the demented range (score < 3 SDs below the mean on NIH Toolbox scores for their age and sex on at least one of the subtests) meet criteria for dementia are unwilling to give written informed consent or accept randomization in either study group are too active (as defined by ≥10 min bouts of MVPA as measured by Actigraph) if: Sum of MVPA bouts for the 7 day wear period ≥40 mins Or ≤40 mins of MVPA 10min bouts AND ≥3 days of bouts have uncontrolled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg). have had a myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis, pulmonary embolus, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months are undergoing cardiopulmonary rehabilitation have uncontrolled diabetes that in the judgment of the MI may interfere with study participation have clinically diagnosed osteoporosis that in the judgment of the MI may interfere with study participation are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions have another member of the household that is a participant in RAATE or RAATE MCI refuse to participate in the study without disclosure of their amyloid PET scan results refuse to allow anonymized versions of their study data for research after this study is completed. have other medical, psychiatric, or behavioral factors that in the judgment of the Principal or Medical Investigator may interfere with study participation or the ability to follow the intervention protocol

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jenny Ricks

Phone

225-763-0939

jenny.ricks@pbrc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Newton, Jr., PhD

Organizational Affiliation

Pennington Biomedical Research

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Owen Carmichael, PhD

Organizational Affiliation

Pennington Biomedical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pennington Biomedical Research

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jenny Ricks, MA

Phone

225-763-0939

jenny.ricks@pbrc.edu

First Name & Middle Initial & Last Name & Degree

Callie Hebert, MS

Phone

225-763-2632

callie.hebert@pbrc.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

For all study data, Pennington Biomedical has a well-structured internal process for data sharing and transfer. The Office of Legal and Regulatory Compliance is responsible for all data agreements which includes data subject to the protection under HIPAA. As part of the Louisiana State University System, Pennington Biomedical ensures that data agreements are in place in the following circumstances: business associate agreements when the transfer of data contains all identifiers, data use agreements when the transfer of data contains those identifiers that constitute a limited data set and a data transfer agreement in instances where data is de-identified, but still may be subject of protection in order to protect intellectual property rights. Transmission of data to ensure proper safeguards are in place on the data in motion and data at reset are carried out with assistance of the Research Computing Group or the Office of Computing Services.

IPD Sharing Time Frame

Data will be available after data analysis has occurred.

Learn more about this trial

Reducing African American's Alzheimer's Risk Through Exercise-Mild Cognitive Impairment (RAATE-MCI)

We'll reach out to this number within 24 hrs