Program for African American Cognition & Exercise

NCT03474302 | Completed

• 1 other identifier: 2017-022
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging

Keywords

African American; Aging; Physical activity; Cognition

Outcome Measures

Primary Outcomes (1)

• Change in steps.

  Steps will be measured by the abtigraph WGT3X+ accelerometer.

  7-day period

Secondary Outcomes (6)

• Change in dementia screening.

  Week 0 and Week 12

• Change in cognition.

  Week 0 and Week 12

• Change in quality of life.

  Week 0 and Week 12

• Change in health care utilization.

  Week 0 and Week 12

• Change in depressive symptoms.

  Week 0 and Week 12

Other Outcomes (1)

• Tailored physical activity program for elderly African American adults

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

Study Arms (2)

Physical Activity

EXPERIMENTAL

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

Behavioral: Physical Activity

Successful Aging

ACTIVE COMPARATOR

Those randomized to the successful aging group will receive health information pertinent to African Americans over the 12 weeks

Other: Successful Aging

Interventions

Physical Activity BEHAVIORAL

Aerobic, strength training, balance, flexibility

Physical Activity

Successful Aging OTHER

Healthy aging education

Successful Aging

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• years of age
• African American
• sedentary or insufficiently active
• not cognitively impaired
• physically capable of exercise
• willing to accept randomization
• willing to attend group sessions
• willing to live in the study area for the next 6 months
• willing to allow researchers to use data for research purposes after study participation is completed
• free of conditions that would make regular exercise unsafe as deemed by the medical investigator

You may not qualify if:

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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• BrightFocus Foundation: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (2)

• 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.

  PMID: 35936770 DERIVED

• 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.

  PMID: 35522253 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Robert Newton, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will not know the group randomization of the participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The randomized controlled trial will assign insufficiently active African American adults aged 65-85 to an intervention or successful aging control group

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 22, 2018
• Study Start: February 19, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)