Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02433691
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2015-04-13
Brief Title:
Memory and Exercise Training Study in Older Adults With Subjective Memory Complaints
Sponsor:
David Merrill MD PhD
Organization:
University of California Los Angeles
Study Overview
Official Title:
Simultaneous Aerobic Exercise and Memory Training in Older Adults With Subjective Memory Complaints
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
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:
MET
Brief Summary:
This pilot study is a first step in a rapidly growing area of clinical research to create the most effective means to combat age-related losses in cognitive function through preventive lifestyle strategies such as physical exercise and memory training This study will develop innovative simultaneous exercise and memory training programs in non-demented volunteers with subjective memory complaints controls or MCI Our primary goal is to assess the cognitive impact of 4-week memory training programs done twice weekly 1 during simultaneous aerobic exercise SIM-AR-MET 2 sequentially after aerobic exercise SEQ-AR-MET or 3 without aerobic exercise replaced with sequential stretching and toning SEQ-ST-MET The investigators will also measure potential metabolic eg glucose lipid panel and molecular serum BDNF mediators of observed cognitive changes in a subset of participants those at the UCLA CTRCIPCN site
Detailed Description:
A total of 90 non-demented healthy older adult volunteers age 60-75 with subjective memory complaints controls or MCI will be screened and enrolled into the study The CTRCIPCN site will enroll 30 subjects 10 in each group the MPTF site will enroll 60 subjects 20 in each group Baseline assessments will include neuropsychological testing of all study subjects At UCLA CTRCIPCN baseline assessments will also include cardiorespiratory fitness body composition YMCA fitness tests and blood-based markers of metabolism and plasticity To control for total activity levels all study subjects will wear continuous physical activity monitors FitBit accelerometers and keep exercise and cognitive activity logs during the entire study All subjects n 90 will first complete a 1-week observational period to capture baseline activity levels Subjects will then be randomized to one of three groups SIM-AR-EMT SEQ-AR-EMT or SEQ-ST-MET n 30 per group SIM-AR-MET and SEQ-AR-MET subjects will complete a 3-week exercise only ramp-up period consisting of twice weekly 1-hour sessions practicing stationary bicycling improving cardiovascular fitness enough to complete the upcoming 4-weeks of MET sessions described below and practicing stretching and toning SEQ-ST-MET subjects 3-week exercise only ramp-up period will consist of an equal number of six stretching and toning sessions no aerobic components All 3 programs will then have two 2-hour sessions per week for 4 weeks The SIM-AR-MET and SEQ-ST-MET subjects will do stretchingtoning during the first hour SEQ-AR-MET subjects will do aerobic cycling during the first hour During the second half of the sessions all 3 groups will first learn new memory training strategies while sedentary SIM-AR-MET subjects will then practice the memory techniques while cycling while SEQ-AR-MET and SEQ-ST-MET subjects will practice the memory techniques while still sedentary The three groups will have group specific exercise and memory training homework assignments along with monitoring of activity and logging of cognitively enriching activities The NP testing will be done again at the end of the 4 weeks of memory training classes for all study subjects UCLA CTRCIPCN subjects will have the additional testing done at baseline eg blood-based markers etc
Consideration was given to having a purely observational wait-list group but in our experience with this population such groups have typically initiated greater levels of self-guided exercise and memory training in reaction to being put on a wait list Alternatively if no increase in activity or memory training is undertaken by wait list subjects the investigators would not expect any differences in cognitive performance to be measurable within the brief 3 month total time frame of this initial study The investigators also considered have a group do aerobic exercise immediately after memory training but based on current literature this combination seemed the least likely to impact memory synergistically Thus these two groups will be deferred for the pilot until later larger studies can be done to confirm or refute these hypotheses Similarly while our primary aim assessing change in NP performance will be tested in all subjects the pilot nature of the study prohibits testing of secondary aims in both sites The academic medical center site will leverage the assistance of the UCLA CTRCIPCN to accomplish preliminary testing of the secondary aims in 30 subjects while the UCLA MPTF community site will test only the primary study aim of change in NP performance
Consideration was given to having a purely observational wait-list group but in our experience with this population such groups have typically initiated greater levels of self-guided exercise and memory training in reaction to being put on a wait list Alternatively if no increase in activity or memory training is undertaken by wait list subjects the investigators would not expect any differences in cognitive performance to be measurable within the brief 3 month total time frame of this initial study The investigators also considered have a group do aerobic exercise immediately after memory training but based on current literature this combination seemed the least likely to impact memory synergistically Thus these two groups will be deferred for the pilot until later larger studies can be done to confirm or refute these hypotheses Similarly while our primary aim assessing change in NP performance will be tested in all subjects the pilot nature of the study prohibits testing of secondary aims in both sites The academic medical center site will leverage the assistance of the UCLA CTRCIPCN to accomplish preliminary testing of the secondary aims in 30 subjects while the UCLA MPTF community site will test only the primary study aim of change in NP performance
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