Program for African American Cognition & Exercise

Aging Clinical Trial

— PAACE  

Official title:

Program for African American Cognition & Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474302
• Other study ID #: 2017-022
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2020
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Physical Activity
Aerobic, strength training, balance, flexibility

Other:
• Successful Aging
Healthy aging education

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	BrightFocus Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tailored physical activity program for elderly African American adults	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
Primary	Change in steps.	Steps will be measured by the abtigraph WGT3X+ accelerometer.	7-day period
Secondary	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.	Week 0 and Week 12
Secondary	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.	Week 0 and Week 12
Secondary	Change in quality of life.	The Health Related Quality of Life questionnaire consists of 27 questions.	Week 0 and Week 12
Secondary	Change in health care utilization.	The Health Care Utilization questionnaire consists of 12 questions. Participants report utilization of various health care avenues.	Week 0 and Week 12
Secondary	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).	Week 0 and Week 12
Secondary	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)	Week 0 and Week 12