- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03474302
Program for African American Cognition & Exercise (PAACE)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Louisiana
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Baton Rouge, Louisiana, Spojené státy, 70808
- Pennington Biomedical Research Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Physical Activity
The intervention will be a 12-week community-based physical activity promotion program
|
Aerobic, strength training, balance, flexibility
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Aktivní komparátor: Successful Aging
Those randomized to the successful aging group will receive health information pertinent to African Americans over the 12 weeks
|
Healthy aging education
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in steps.
Časové okno: 7-day period
|
Steps will be measured by the abtigraph WGT3X+ accelerometer.
|
7-day period
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in dementia screening.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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).
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Week 0 and Week 12
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Change in resilience.
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Tailored physical activity program for elderly African American adults
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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