Ignite Creation Date:
2024-05-06 @ 7:52 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02614365
Status:
UNKNOWN
Last Update Posted:
2021-03-02
First Post:
2015-03-24
Brief Title:
Genes Exercise Neurocognitive and Neurodegeneration Community-Based Approach
Sponsor:
Howard University
Organization:
Howard University
Study Overview
Official Title:
Genes Exercise Neurocognitive and Neurodegeneration Community-Based Approach
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEMSII
Brief Summary:
Whereas the advantageous effects of exercise-training on memory is increasingly recognized the practicality and clinical usefulness of such interventions in community-dwelling older African Americans AAs Mild Cognitively Impaired MCI subjects and the mechanism by which an effect occurs need elucidation Because aerobic-exercise can improve emerging cardiovascular CVD-related risk factors for cognitive decline such as lipids inflammatory cytokines and glucose homeostasis the Investigators will examine training effects on these and related biomarkers The imperative for this study is further underscored by the fact that AAs i have high rates of dementia and ii have paucity of cross-sectional and lack prospective data on the effects of exercise on cognition To overcome barriers to recruitment and retention enhance compliance with a long exercise program 3-timesweek and maximize the use of available resources the Investigators will use a community-based approach Therefore the primary objectives of this study build on the Investigators experience and will compare the effects of aerobic-exercise to stretch-exercise control in community-dwelling AA MCI subjects Following the initial 6 months active intervention the aerobic-exercise group will follow a prescribed but free living 40 minutes 3 timeweek exercise regimen while the control group returns to usual care plus stretch-exercise for additional 12 months This study will facilitate the estimation of sample size for a larger confirmatory study in AAs A newly acquired direct oversight of the DC Ward-6 Senior Wellness Center and its infrastructures by the Howard University Division of Geriatrics will provide additional resources and access to the community In addition to the Investigators feasibility aims the Investigators will determine performance on cognitive tasks using the Alzheimers Disease Assessment Scale-Cognitive Sub-scale ADAS-Cog and Clinical Dementia Rating Scale CDR sum of boxes supplemented by tests of executive function EF and Functional Activity Questionnaire FA and together as ADAS-Cog-Plus changes in brain volume regions of interest ROI with Magnetic Resonance Imaging MRI selected CVD and AD-related bio-markers
Detailed Description:
Although anticholinesterase therapies have greatly improved the symptomatic treatment of Alzheimers disease AD they have not been demonstrated to significantly slow the disease progression and amyloid-directed therapies have produced disappointing results A promising evidence-based and relatively side-effect free lifestyle approach is emerging as an alternative or adjunct to drug therapy In cross-section and prospective studies and a few randomized controlled trials aerobic exercise-training has been demonstrated to improve cognition in older subjects However the mechanisms of these effects remain poorly understood Because it is now recognized that cardiovascular disease CVD risks can catalyze AD development it is vital to test whether lifestyle adaptation shown to reduce CVD risks can favorably modify cognitive trajectories and markers of neurodegeneration Such interventions may benefit those at an early and clinically discernible prodromal stage of AD such as mild cognitive impairment MCI Notably such data are currently lacking in African Americans AAs who harbor higher rate of CVD risks and AD
While a laboratory approach to exercise intervention study is required to prove causation such a design may not lend itself to real-life application and is demanding for many economically and educationally disadvantaged older AAs experiencing early symptoms of cognitive deterioration To address this concern the Investigators seek to initiate an 18-month study testing real-life applicability of the effects of exercise adaptation on memory in a more ideal community setting However those who chose to exercise at an academic center will not be excluded Collection of outcome measures at baseline 3-month 6-month 9-month 12-month and 18-month will provide pilot data to inform dose and duration effects of exercise on outcome measures In addition to augmenting enrollments the proposed approach will bolster retention
The objectives of this pilot study therefore are to examine the feasibility of a community-based 18-month study 6-month active intervention and 12-month passive follow-up aerobic exercise-training on neurodegeneration in AAs MCI subjects The Investigators will test the hypotheses by randomizing subjects into one of 2 groups 1 aerobic-exercise and 2 stretch-exercise control The Investigators proposed that the aerobic-exercise group will perform better than control group on cognitive measures Secondarily the Investigators will determine whether training-induced changes in cognition relate to increases in brain volume Exploratory the Investigators will also investigate intervention effects on cerebrospinal fluid CSF biomarkers selected CVD risk factors and biomarkers cerebral oxygenation and Hypoxia-Inducible Factors HIF-1α gene expression and Apolipoprotein E gene APOE to assess their mediation of training-induced changes in cognition
A team of experienced Investigators in neuroimaging neurology cognitive neuroscience and exercise physiology has been assembled to conduct this study Working collaboratively with the District of Columbia Office on Aging DCOA the Directors of the Ward 6 Senior Wellness Center operated by DCOA and the lead agencies on aging community grassroots organizations supported by DCOA the Investigators will recruit enroll randomize and train participants at the wellness center After obtaining informed consent and completing an initial assessment participants will undergo initial exercise screening to determine their ability to exercise safely Following randomization of 80 volunteers into aerobic-exercise 40 and control 40 baseline neuropsychological neuroimaging and biomarker measurements will be obtained Both groups will undergo 3 timesweek supervised group-specific intervention at the wellness center for 6 months After the initial 6 months of active intervention the aerobic-exercise group will follow a prescribed but free living 40 minutes 3 timeweek exercise regimen while the control group returns to usual care Baseline tests will be repeated at 3 month after 6 months active intervention period and at 9 12 and 18 months passive follow-up period Treadmill lumber puncture LP and brain magnetic resonance imaging MRI tests will occur only at baseline and 6 months Between groups changes in cognitive performance biomarkers and neuroimaging measurements will be compared using appropriate multivariate methods
While the Investigators remain cognizant of other planned or ongoing fitness and memory trial the proposed study is unique in the sense that it is a logical extension of the Investigators ongoing work tests the proposed hypotheses in predominantly AA sample in whom paucity of data remains and therefore will advance reduction in health disparity will obtain data at multiple time-points baseline 3 6 9 12 and 18 months and therefore allow for the assessments of the effects of duration and dose of intervention on outcome measures test the real-life applicability of the proposed intervention in a community setting and generate pilot data on the mechanisms by which these interventions affects memory Importantly outcomes from this study may lead to practical and effective strategy to delay cognitive decline in populations at most risk and can prevent or attenuate the physical psychological and the economic burden associated with dementia in AAs
While a laboratory approach to exercise intervention study is required to prove causation such a design may not lend itself to real-life application and is demanding for many economically and educationally disadvantaged older AAs experiencing early symptoms of cognitive deterioration To address this concern the Investigators seek to initiate an 18-month study testing real-life applicability of the effects of exercise adaptation on memory in a more ideal community setting However those who chose to exercise at an academic center will not be excluded Collection of outcome measures at baseline 3-month 6-month 9-month 12-month and 18-month will provide pilot data to inform dose and duration effects of exercise on outcome measures In addition to augmenting enrollments the proposed approach will bolster retention
The objectives of this pilot study therefore are to examine the feasibility of a community-based 18-month study 6-month active intervention and 12-month passive follow-up aerobic exercise-training on neurodegeneration in AAs MCI subjects The Investigators will test the hypotheses by randomizing subjects into one of 2 groups 1 aerobic-exercise and 2 stretch-exercise control The Investigators proposed that the aerobic-exercise group will perform better than control group on cognitive measures Secondarily the Investigators will determine whether training-induced changes in cognition relate to increases in brain volume Exploratory the Investigators will also investigate intervention effects on cerebrospinal fluid CSF biomarkers selected CVD risk factors and biomarkers cerebral oxygenation and Hypoxia-Inducible Factors HIF-1α gene expression and Apolipoprotein E gene APOE to assess their mediation of training-induced changes in cognition
A team of experienced Investigators in neuroimaging neurology cognitive neuroscience and exercise physiology has been assembled to conduct this study Working collaboratively with the District of Columbia Office on Aging DCOA the Directors of the Ward 6 Senior Wellness Center operated by DCOA and the lead agencies on aging community grassroots organizations supported by DCOA the Investigators will recruit enroll randomize and train participants at the wellness center After obtaining informed consent and completing an initial assessment participants will undergo initial exercise screening to determine their ability to exercise safely Following randomization of 80 volunteers into aerobic-exercise 40 and control 40 baseline neuropsychological neuroimaging and biomarker measurements will be obtained Both groups will undergo 3 timesweek supervised group-specific intervention at the wellness center for 6 months After the initial 6 months of active intervention the aerobic-exercise group will follow a prescribed but free living 40 minutes 3 timeweek exercise regimen while the control group returns to usual care Baseline tests will be repeated at 3 month after 6 months active intervention period and at 9 12 and 18 months passive follow-up period Treadmill lumber puncture LP and brain magnetic resonance imaging MRI tests will occur only at baseline and 6 months Between groups changes in cognitive performance biomarkers and neuroimaging measurements will be compared using appropriate multivariate methods
While the Investigators remain cognizant of other planned or ongoing fitness and memory trial the proposed study is unique in the sense that it is a logical extension of the Investigators ongoing work tests the proposed hypotheses in predominantly AA sample in whom paucity of data remains and therefore will advance reduction in health disparity will obtain data at multiple time-points baseline 3 6 9 12 and 18 months and therefore allow for the assessments of the effects of duration and dose of intervention on outcome measures test the real-life applicability of the proposed intervention in a community setting and generate pilot data on the mechanisms by which these interventions affects memory Importantly outcomes from this study may lead to practical and effective strategy to delay cognitive decline in populations at most risk and can prevent or attenuate the physical psychological and the economic burden associated with dementia in AAs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None