Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline

Cognitive Decline Clinical Trial

— BDJ  

Official title:

Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04009382
• Other study ID #: 2018P001997
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2022
• Source: Massachusetts General Hospital
• Contact: Maya Eshel
• Phone: 617-726-5004
• Email: meshel[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

Other:
• Baduanjin Exercise
Subjects will participate in Baduanjin, a simple mind-body exercise, for 24 weeks.
• Cognitive Fitness Program
Subjects will complete paper puzzles (Sudoku, crosswords, etc.) for 24 weeks.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer Disease Cooperative Study- Preclinical Alzheimer (ADCS-PACC) Cognitive Composite	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.	baseline, 3, 6, 9 months
Primary	Functional connectivity of hippocampus and DLPFC	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.	baseline, 3, 6 months
Secondary	Everyday Cognition -Subject/Self Report Form (ECog-self report and informant)	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.	baseline, 3, 6, 9 months
Secondary	Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)	PROMIS-29 will be used to assess physical function, depression, anxiety, fatigue, sleep, social activity and pain in the past 7 days.	baseline, 3, 6, 9 months
Secondary	Brain morphometry	The imaging endpoint is to assess brain grey matter volume changes using before and after BDJ exercise and magnetic resonance imaging (MRI).	baseline, 3, 6 months
Secondary	Blood markers	Circulating markers, such as C reactive protein, proinflammatory cytokine IL-6, and BDNF will be measured to investigate the modulation effect of Baduanjin.	baseline, 3, 6, 9 months
Secondary	Heart rate variability	The secondary endpoints include measuring low frequency, high frequency, and LF to HF ratio (LF/HF) of heart rate variability as measured by ECG.	baseline, 3, 6, 9 months
Secondary	Beck Anxiety Inventory (BAI)	The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults	baseline, 3, 6, 9 months
Secondary	Symbol Digit Modalities Test (SDMT)	This is an oral version of the Digit Symbol Substitution Test	baseline, 3, 6, 9 months
Secondary	The Stroop Color and Word Test (SCWT)	This is a test to assess executive functions, the ability to inhibit cognitive interference, attention, processing speed, and cognitive flexibility.	baseline, 3, 6, 9 months
Secondary	Trail-making Test A and B	This is a test of speeded visual search, vigilance, and set-shifting.	baseline, 3, 6, 9 months
Secondary	Controlled Oral Word Association Test, Category Fluency and Category Switching	These are tests of rapid word retrieval, cognitive flexibility, and semantic access/semantic network integrity.	baseline, 3, 6, 9 months
Secondary	Patient Reported Outcomes Measurement Information System - Cognition Function and ability subset	The PROMIS Cognitive Function and Cognitive Function Abilities Subset item banks assess patient-perceived cognitive deficits	baseline, 3, 6, 9 months
Secondary	The California Verbal Learning Test-II (CVLT-II)	CVLT-II is a comprehensive assessment of verbal learning and memory available for older adolescents and adults.	baseline, 3, 6, 9 months
Secondary	Modified Brief Pain Inventory (BPI)	The BPI is a 15-item questionnaire rating pain location, intensity, relief, quality, and pain-related quality of life.	baseline, 3, 6, 9 months
Secondary	Brief Quantitative Sensory Testing (QST)	QST will include mechanical and heat pain threshold and tolerance measurements	baseline, 3, 6, 9 months