RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-06-01

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04956549

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. are African American (self-identify) 2. are 60 and older 3. are physically capable of exercise 4. are willing to accept randomization 5. are willing to attend group sessions 6. 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 7. 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 8. have not engaged in regular physical activity 9. have a Short Physical Performance Battery ≥4 10. physically capable of exercise 11. are unable to utilize devices and/or applications as required for study participation 12. willing to attend group sessions 13. willing to allow researchers to use data for research purposes after study participation is completed 14. 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)	1. have cognitive impairment that would interfere with participating in a group discussion 2. meet criteria for dementia 3. are unwilling to give written informed consent or accept randomization in either study group 4. 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 5. have uncontrolled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg). 6. 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 7. are undergoing cardiopulmonary rehabilitation 8. have uncontrolled diabetes that in the judgment of the MI may interfere with study participation 9. have clinically diagnosed osteoporosis that in the judgment of the MI may interfere with study participation 10. are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions 11. have another member of the household that is a participant in RAATE or RAATE MCI 12. refuse to participate in the study without disclosure of their amyloid PET scan results 13. refuse to allow anonymized versions of their study data for research after this study is completed. 14. 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

Inclusion Criteria

Exclusion Criteria

1. are African American (self-identify)
2. are 60 and older
3. are physically capable of exercise
4. are willing to accept randomization
5. are willing to attend group sessions
6. 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
7. 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
8. have not engaged in regular physical activity
9. have a Short Physical Performance Battery ≥4
10. physically capable of exercise
11. are unable to utilize devices and/or applications as required for study participation
12. willing to attend group sessions
13. willing to allow researchers to use data for research purposes after study participation is completed
14. 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)

1. have cognitive impairment that would interfere with participating in a group discussion
2. meet criteria for dementia
3. are unwilling to give written informed consent or accept randomization in either study group
4. 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
5. have uncontrolled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg).
6. 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
7. are undergoing cardiopulmonary rehabilitation
8. have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
9. have clinically diagnosed osteoporosis that in the judgment of the MI may interfere with study participation
10. are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
11. have another member of the household that is a participant in RAATE or RAATE MCI
12. refuse to participate in the study without disclosure of their amyloid PET scan results
13. refuse to allow anonymized versions of their study data for research after this study is completed.
14. 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

Contacts and Locations

Study Contact

Callie Hebert, MS

CONTACT

225-763-2362

callie.hebert@pbrc.edu

Principal Investigator

Robert L Newton, Jr., PhD

PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research

Owen Carmichael, PhD

PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research

Study Locations (Sites)

Pennington Biomedical Research

Baton Rouge, Louisiana, 70808

United States

Collaborators and Investigators

Sponsor: Pennington Biomedical Research Center

Robert L Newton, Jr., PhD, PRINCIPAL_INVESTIGATOR, Pennington Biomedical Research
Owen Carmichael, PhD, PRINCIPAL_INVESTIGATOR, Pennington Biomedical Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-01

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2021-06-01

Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

Dementia of Alzheimer Type