Program for African American Cognition & Exercise (PAACE)

June 23, 2020 updated by: Robert L. Newton, Jr., Pennington Biomedical Research Center
The study is designed to develop and evaluate a physical activity promotion program among elderly African Americans with a long-term goal of reducing risk of Alzheimer's disease. The motivation for this study is that previous exercise interventions have improved cognitive function in older adults with and without cognitive impairments, but these studies were largely conducted without substantial African American representation. Due to genetic and environmental differences between African American and other populations, it is unclear whether positive findings from previous interventions will translate to African American individuals. Investigators hypothesize that a community-based physical activity intervention will a) be tailored to African American adults, b) increase daily amounts of physical activity, and c) improve cognitive function in sedentary older African American adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators will randomize 56 older African American adults into 1) a physical activity intervention specifically tailored to older African American or 2) a successful aging group. The 12-week physical activity intervention will consist of group based exercise sessions at a community facility and the successful aging groups will occur at Pennington Biomedical. Cognitive functioning and blood markers of circulating neurotrophic factors will be assessed to determine the brain effects of physical activity in this understudied population.

Specific Aim 1: To tailor a physical activity promotion intervention to community-dwelling African American elderly adults. Investigators will use focus groups to gather information needed to tailor a physical activity program to elderly African Americans.

Specific Aim 2: To determine if a physical activity promotion intervention in African American adults is effective in modifying physical activity and biological markers.

Specific Aim 3: To determine if a physical activity promotion intervention in African American adults benefits cognition and brain health. Change over the course of the intervention will be assessed in key AD related cognitive domains (memory, executive function, and processing speed).

Collecting this data sets the stage for the definitive study of exercise benefits on measures of amyloid, tau, inflammation, brain metabolism, and other AD-relevant pathways in elderly African Americans, which could in turn increase understanding of neurobiological mechanisms and optimal physical activity recommendations for elderly African Americans.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

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.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 65 - 85 years of age
  2. African American
  3. sedentary or insufficiently active
  4. not cognitively impaired
  5. physically capable of exercise
  6. willing to accept randomization
  7. willing to attend group sessions
  8. willing to live in the study area for the next 6 months
  9. willing to allow researchers to use data for research purposes after study participation is completed
  10. free of conditions that would make regular exercise unsafe as deemed by the medical investigator

Exclusion Criteria:

  1. unable or unwilling to give informed consent or accept randomization in either study group
  2. are cognitively impaired (MMSE score of ≤ 26)
  3. are unable to complete physical activity requirements (SPPB ≤ 3, complete 2 minute walk without sitting or resting against a surface)
  4. are too active (steps per day > 50th percentile for age and gender)
  5. have uncontrolled hypertension (systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg).
  6. gave had a hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
  7. have had a myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 6 months
  8. are undergoing physical therapy or cardiopulmonary rehabilitation
  9. are currently enrolled in another randomized trial involving lifestyle or pharmaceutical interventions
  10. have another member of the household that is a participant in PAACE
  11. have plans to relocate out of the study area within the next 6 months
  12. have uncontrolled diabetes that in the judgment of the MI may interfere with study participation
  13. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical Activity
The intervention will be a 12-week community-based physical activity promotion program
Behavioral: Physical Activity
Aerobic, strength training, balance, flexibility
Active Comparator: Successful Aging
Those randomized to the successful aging group will receive health information pertinent to African Americans over the 12 weeks
Other: Successful Aging
Healthy aging education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in steps.
Time Frame: 7-day period
Steps will be measured by the abtigraph WGT3X+ accelerometer.
7-day period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dementia screening.
Time Frame: Week 0 and Week 12
The Mini-Mental State Examination (MMSE) is a 30-item measure of cognitive function. Scores range from 0-30, higher scores represent better global cognitive functioning.
Week 0 and Week 12
Change in cognition.
Time Frame: Week 0 and Week 12
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a brief, individually administered battery to measure cognitive decline or improvement. Four subtests of the full battery of 12 subtests used to assess immediate memory (List Learning and Story Memory), as well as language capacities (i.e., Picture Naming and Semantic Fluency). T-scores are derived, higher scores represent better functioning.
Week 0 and Week 12
Change in quality of life.
Time Frame: Week 0 and Week 12
The Health Related Quality of Life questionnaire consists of 27 questions.
Week 0 and Week 12
Change in health care utilization.
Time Frame: Week 0 and Week 12
The Health Care Utilization questionnaire consists of 12 questions. Participants report utilization of various health care avenues.
Week 0 and Week 12
Change in depressive symptoms.
Time Frame: Week 0 and Week 12
The Geriatric Depression Scale (GDS) measures depressive symptoms specifically in an elderly population. Total scores range from 0 (no depressive symptoms) to 15 (indicative of depression).
Week 0 and Week 12
Change in resilience.
Time Frame: Week 0 and Week 12
The 25-item Connor-Davidson Resilience Scale (CD-RISC 25) collects information on resilience, which is the ability to thrive despite adversity. The total score ranges from 0 (low resilience) to 100 (higher resilience)
Week 0 and Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tailored physical activity program for elderly African American adults
Time Frame: 1.5 hour focus groups prior to RCT. Recruitment, retention and protocol compliance throughout the intervention
Use focus groups to gather information needed to tailor a physical activity program
1.5 hour focus groups prior to RCT. Recruitment, retention and protocol compliance throughout the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

BrightFocus Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

February 19, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

March 15, 2018

First Posted (Actual)

March 22, 2018

Study Record Updates

Last Update Posted (Actual)

June 25, 2020

Last Update Submitted That Met QC Criteria

June 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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