ClinicalTrials.gg
CompletedNCT03474302PAACEUpdated Jun 25, 2020

Program for African American Cognition & Exercise

An interventional study of Physical Activity and Successful Aging in Aging, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-25.

Sponsored by Pennington Biomedical Research Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 39 studies in Motor Activity by Pennington Biomedical Research Center — 2 open to participants now, 3 under way, none of them phase 3. Motor Activity · Pennington Biomedical Research Center.

Enrollment
10th of 27
56 · median 41
Started
2018
with 4 others
No phase
23 of 39
1 open now
Registered
28th of 39
by date

Among the 39 studies in Motor Activity by Pennington Biomedical Research Center, this one is the 10th largest by enrollment of the 27 interventional ones that give a count, is one of 5 that started in 2018, is one of 23 with no phase, and was the 28th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

2 of the 39 studies in Motor Activity by Pennington Biomedical Research Center are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 65 Years to 85 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 39 studies in Motor Activity by Pennington Biomedical Research Center, or all of them as a file.
02

Study summary

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.

Read the 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.

03

Conditions studied

  • Aging

Browse trials for

Keywords

  • African American
  • Aging
  • Physical activity
  • Cognition
04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. unable or unwilling to give or accept randomization in either study group
  2. are cognitively impaired ( 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Physical Activity

    The intervention will be a 12-week community-based physical activity promotion program

    Behavioral: Physical Activity

  • 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

Interventions

  • BehavioralPhysical Activity

    Aerobic, strength training, balance, flexibility

  • OtherSuccessful Aging

    Healthy aging education

06

What researchers measure

Primary outcomes

  1. Change in steps.

    Steps will be measured by the abtigraph WGT3X+ accelerometer.

    Time frame: 7-day period

Secondary outcomes

  1. Change in dementia screening.

    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.

    Time frame: Week 0 and Week 12

  2. Change in cognition.

    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.

    Time frame: Week 0 and Week 12

  3. Change in quality of life.

    The Health Related Quality of Life questionnaire consists of 27 questions.

    Time frame: Week 0 and Week 12

  4. Change in health care utilization.

    The Health Care Utilization questionnaire consists of 12 questions. Participants report utilization of various health care avenues.

    Time frame: Week 0 and Week 12

  5. Change in depressive symptoms.

    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).

    Time frame: Week 0 and Week 12

  6. Change in resilience.

    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)

    Time frame: Week 0 and Week 12

Other outcomes

  1. Tailored physical activity program for elderly African American adults

    Use focus groups to gather information needed to tailor a physical activity program

    Time frame: 1.5 hour focus groups prior to RCT. Recruitment, retention and protocol compliance throughout the intervention

07

Study locations

1 site
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
08

References and documents

Publications

  • Gwizdala KL, Brouillete R, Beyl R, Johnson W, Hebert C, Carter L, Harris M, Newton RL Jr, Carmichael OT. Exercise Effects on Cognition in Older African Americans: A Pilot Randomized Trial. Front Aging Neurosci. 2022 Jul 22;14:921978. doi: 10.3389/fnagi.2022.921978. eCollection 2022. PubMed 35936770 ↗
  • Newton RL Jr, Beyl R, Hebert C, Harris M, Carter L, Gahan W, Carmichael O. A Physical Activity Intervention in Older African Americans: The PAACE Pilot Randomized Controlled Trial. Med Sci Sports Exerc. 2022 Oct 1;54(10):1625-1634. doi: 10.1249/MSS.0000000000002956. Epub 2022 May 7. PubMed 35522253 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Jun 2019, 16 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 16 months is close to that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2018
First posted
Mar 22, 2018
StartActual
Feb 19, 2018
Primary completionActual
Jun 30, 2019
CompletionActual
Jun 30, 2019
Last update
Jun 25, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03474302
Collaborators
BrightFocus Foundation
Responsible party
Robert L. Newton, Jr. (Associate Professor, Pennington Biomedical Research Center) — Principal investigator
First posted
Mar 22, 2018
Start date
Feb 19, 2018
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Last update
Jun 25, 2020

Study contacts

Robert Newton, PhD
principal investigator · Pennington Biomedical Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion