Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
NCT Number: NCT04009382
The aim of this study is to investigate the modulation effects of Baduanjin (BDJ), a simple and innovative mind-body exercise, on cognitive function, resting state functional connectivity, and brain morphometry in individuals with subjective cognitive decline (SCD). The results obtained will provide novel insights for improving the prevention of age-related cognitive decline and Alzheimer's disease.
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Notify Me50 year–80 year
All sexes
Interventional
Not applicable
Charlestown, Massachusetts, 02129, United States
Subjective cognitive decline (SCD), the self-reported perception of memory or cognitive problems, is receiving increasing attention as a risk factor for the development of Alzheimer's disease (AD). Since SCD manifests before the onset of clinical impairment, it might be the optimal stage/window of time at which to intervene with preventative therapies for AD and age-related dementia before the progressive neurological loss and irreversible cognitive impairment.
Recently, mind-body interventions have demonstrated their potential in preventing cognitive decline. Nevertheless, these mind-body therapies encompass a family of complex practices, each with different characteristics and focus. Therefore, they may be associated with different mechanisms and treatment effects. Baduanjin (BDJ) is an innovative and simple mind-body exercise consisting of eight simple movements that can be easily practiced at home with video guidance, thereby making it a more suitable option for older adults with cognitive decline than other more complex exercises.
We believe that this study will 1) significantly improve the prevention of MCI and AD and directly benefit patients suffering from these highly prevalent disorders, 2) enhance the investigators' understandings of the neurobiology through which mind-body interventions affect cognition and health, and 3) advance the investigators' understandings of the pathophysiology and development of SCD, AD, and age-related dementia.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will participate in Baduanjin, a simple mind-body exercise, for 24 weeks.
Subjects will complete paper puzzles (Sudoku, crosswords, etc.) for 24 weeks.
Time frame: baseline, 3, 6, 9 months
The ADCS-PACC is a composite of well-validated neuropsychological tests that were selected specifically due to their sensitivity in tracking the earliest evidence of decline from normal to subtly abnormal cognitive performance.
Time frame: baseline, 3, 6 months
Resting state functional connectivity of the hippocampus and dorsolateral prefrontal cortex (DLPFC) based on resting state functional magnetic resonance imaging (fMRI) data will be used.
Time frame: baseline, 3, 6, 9 months
The Ecog was developed to 1) measure relatively mild functional changes that may predate loss of independence in major activities of daily living; and 2) assess functional abilities that are clearly linked to specific cognitive abilities.
Time frame: baseline, 3, 6, 9 months
PROMIS-29 will be used to assess physical function, depression, anxiety, fatigue, sleep, social activity and pain in the past 7 days.
Time frame: baseline, 3, 6 months
The imaging endpoint is to assess brain grey matter volume changes using before and after BDJ exercise and magnetic resonance imaging (MRI).
Time frame: baseline, 3, 6, 9 months
Circulating markers, such as C reactive protein, proinflammatory cytokine IL-6, and BDNF will be measured to investigate the modulation effect of Baduanjin.
Time frame: baseline, 3, 6, 9 months
The secondary endpoints include measuring low frequency, high frequency, and LF to HF ratio (LF/HF) of heart rate variability as measured by ECG.
Time frame: baseline, 3, 6, 9 months
The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults
Time frame: baseline, 3, 6, 9 months
This is an oral version of the Digit Symbol Substitution Test
Time frame: baseline, 3, 6, 9 months
This is a test to assess executive functions, the ability to inhibit cognitive interference, attention, processing speed, and cognitive flexibility.
Time frame: baseline, 3, 6, 9 months
This is a test of speeded visual search, vigilance, and set-shifting.
Time frame: baseline, 3, 6, 9 months
These are tests of rapid word retrieval, cognitive flexibility, and semantic access/semantic network integrity.
Time frame: baseline, 3, 6, 9 months
The PROMIS Cognitive Function and Cognitive Function Abilities Subset item banks assess patient-perceived cognitive deficits
Time frame: baseline, 3, 6, 9 months
CVLT-II is a comprehensive assessment of verbal learning and memory available for older adolescents and adults.
Time frame: baseline, 3, 6, 9 months
The BPI is a 15-item questionnaire rating pain location, intensity, relief, quality, and pain-related quality of life.
Time frame: baseline, 3, 6, 9 months
QST will include mechanical and heat pain threshold and tolerance measurements
Massachusetts General Hospital
Other
Modulation Effects of Baduanjin Mind-body Exercise on Subjective Cognitive Decline
Acronym: BDJ
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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