Program for African American Cognition & Exercise (PAACE)
2020년 6월 23일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
56
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Louisiana
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Baton Rouge, Louisiana, 미국, 70808
- Pennington Biomedical Research Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
65년 (고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- 65 - 85 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
Exclusion Criteria:
- 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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Physical Activity
The intervention will be a 12-week community-based physical activity promotion program
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Aerobic, strength training, balance, flexibility
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활성 비교기: Successful Aging
Those randomized to the successful aging group will receive health information pertinent to African Americans over the 12 weeks
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Healthy aging education
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in steps.
기간: 7-day period
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Steps will be measured by the abtigraph WGT3X+ accelerometer.
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7-day period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in dementia screening.
기간: Week 0 and Week 12
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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.
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Week 0 and Week 12
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Change in cognition.
기간: Week 0 and Week 12
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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.
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Week 0 and Week 12
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Change in quality of life.
기간: Week 0 and Week 12
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The Health Related Quality of Life questionnaire consists of 27 questions.
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Week 0 and Week 12
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Change in health care utilization.
기간: Week 0 and Week 12
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The Health Care Utilization questionnaire consists of 12 questions.
Participants report utilization of various health care avenues.
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Week 0 and Week 12
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Change in depressive symptoms.
기간: Week 0 and Week 12
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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).
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Week 0 and Week 12
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Change in resilience.
기간: Week 0 and Week 12
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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)
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Week 0 and Week 12
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tailored physical activity program for elderly African American adults
기간: 1.5 hour focus groups prior to RCT. Recruitment, retention and protocol compliance throughout the intervention
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Use focus groups to gather information needed to tailor a physical activity program
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1.5 hour focus groups prior to RCT. Recruitment, retention and protocol compliance throughout the intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 2월 19일
기본 완료 (실제)
2019년 6월 30일
연구 완료 (실제)
2019년 6월 30일
연구 등록 날짜
최초 제출
2018년 3월 15일
QC 기준을 충족하는 최초 제출
2018년 3월 15일
처음 게시됨 (실제)
2018년 3월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 6월 25일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 6월 23일
마지막으로 확인됨
2020년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2017-022
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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