Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline (BDJ)

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Decline
• Intervention / Treatment: Other: Baduanjin Exercise; Other: Cognitive Fitness Program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Eshel; Phone Number: 617-726-5004; Email: meshel@mgh.harvard.edu
• Study Contact Backup: Name: Jian Kong; Phone Number: 617-7267893; Email: jkong2@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Jian Kong; Phone Number: 617-726-7893; Email: jkong2@partner.org
      • Principal Investigator: Jian Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baduanjin; This group will participate in the Baduanjin exercise intervention for 24 weeks (three times/week for the first three months and two times/week for the last three months).	Other: Baduanjin Exercise; Subjects will participate in Baduanjin, a simple mind-body exercise, for 24 weeks.
Active Comparator: Cognitive Fitness Program; This group will participate in the Cognitive Fitness Program intervention for 24 weeks (three times/week for the first three months and two times/week for the last three months).	Other: Cognitive Fitness Program; Subjects will complete paper puzzles (Sudoku, crosswords, etc.) for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Symbol Digit Modalities Test (SDMT)	This is an oral version of the Digit Symbol Substitution Test	baseline, 3, 6, 9 months
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
Trail-making Test A and B	This is a test of speeded visual search, vigilance, and set-shifting.	baseline, 3, 6, 9 months
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
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
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
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
Brief Quantitative Sensory Testing (QST)	QST will include mechanical and heat pain threshold and tolerance measurements	baseline, 3, 6, 9 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2018P001997

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No