Clinical trial NCT04009382: Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline
Official title: Modulation Effects of Baduanjin Mind-body Exercise on Subjective Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Decline
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 124
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 50 - 80 years old
* Self-reported experience of persistent decline in memory compared with a previous state (within the past 5 years), which was further confirmed by informants
* Concerns regarding memory problems
* Mini-Mental State Examination, Second Edition (MMSE-2) scores within the normal range
* Montreal Cognitive Assessment scores within the normal range (adjusted for age, sex, and education)
* Clinical Dementia Rating score of 0 (no memory loss or slight, inconsistent forgetfulness)

Exclusion Criteria:

* Unable to speak or read English
* Diagnosis of depression
* Other diseases that cause cognitive decline (e.g., traumatic brain injury, stroke, neurodegenerative diseases, brain tumor, Parkinson disease, encephalitis or epilepsy, thyroid dysfunction, severe anemia, syphilis)
* History of psychosis or congenital mental growth retardation
* Any delayed recall index greater than 1.5 SD below average on the California Verbal Learning Test, Second Edition
* Failing the Memory items on the MMSE-2 and MDRS-2, as well as the CVLT-II criterion
* Inability to participate in a 6-month intervention with a 3-month follow-up
* Any item = 0 on the Lawton-Brody Instrumental Activities of Daily Living Scale for cognitive reasons
* No available informant
* Previous diagnosis of MCI, AD, or other age-related dementia
* Previous Baduanjin experience

Primary outcomes:
measure: Alzheimer Disease Cooperative Study- Preclinical Alzheimer (ADCS-PACC) Cognitive Composite
timeFrame: baseline, 3, 6, 9 months
measure: Functional connectivity of hippocampus and DLPFC
timeFrame: baseline, 3, 6 months
Secondary outcomes:
measure: Everyday Cognition -Subject/Self Report Form (ECog-self report and informant)
timeFrame: baseline, 3, 6, 9 months
measure: Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
timeFrame: baseline, 3, 6, 9 months
measure: Brain morphometry
timeFrame: baseline, 3, 6 months
measure: Blood markers
timeFrame: baseline, 3, 6, 9 months
measure: Heart rate variability
timeFrame: baseline, 3, 6, 9 months
measure: Beck Anxiety Inventory (BAI)
timeFrame: baseline, 3, 6, 9 months
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: baseline, 3, 6, 9 months
measure: The Stroop Color and Word Test (SCWT)
timeFrame: baseline, 3, 6, 9 months
measure: Trail-making Test A and B
timeFrame: baseline, 3, 6, 9 months
measure: Controlled Oral Word Association Test, Category Fluency and Category Switching
timeFrame: baseline, 3, 6, 9 months
measure: Patient Reported Outcomes Measurement Information System - Cognition Function and ability subset
timeFrame: baseline, 3, 6, 9 months
measure: The California Verbal Learning Test-II (CVLT-II)
timeFrame: baseline, 3, 6, 9 months
measure: Modified Brief Pain Inventory (BPI)
timeFrame: baseline, 3, 6, 9 months
measure: Brief Quantitative Sensory Testing (QST)
timeFrame: baseline, 3, 6, 9 months
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: