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

Primary Purpose

Cognitive Decline

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baduanjin Exercise
Cognitive Fitness Program
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Baduanjin

Cognitive Fitness Program

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Brain morphometry
The imaging endpoint is to assess brain grey matter volume changes using before and after BDJ exercise and magnetic resonance imaging (MRI).
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.
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.
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
Symbol Digit Modalities Test (SDMT)
This is an oral version of the Digit Symbol Substitution Test
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.
Trail-making Test A and B
This is a test of speeded visual search, vigilance, and set-shifting.
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.
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
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.
Modified Brief Pain Inventory (BPI)
The BPI is a 15-item questionnaire rating pain location, intensity, relief, quality, and pain-related quality of life.
Brief Quantitative Sensory Testing (QST)
QST will include mechanical and heat pain threshold and tolerance measurements

Full Information

First Posted
July 1, 2019
Last Updated
December 29, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04009382
Brief Title
Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline
Acronym
BDJ
Official Title
Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Baduanjin
Arm Type
Experimental
Arm Description
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).
Arm Title
Cognitive Fitness Program
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Baduanjin Exercise
Intervention Description
Subjects will participate in Baduanjin, a simple mind-body exercise, for 24 weeks.
Intervention Type
Other
Intervention Name(s)
Cognitive Fitness Program
Intervention Description
Subjects will complete paper puzzles (Sudoku, crosswords, etc.) for 24 weeks.
Primary Outcome Measure Information:
Title
Alzheimer Disease Cooperative Study- Preclinical Alzheimer (ADCS-PACC) Cognitive Composite
Description
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, 9 months
Title
Functional connectivity of hippocampus and DLPFC
Description
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 months
Secondary Outcome Measure Information:
Title
Everyday Cognition -Subject/Self Report Form (ECog-self report and informant)
Description
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
Title
Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
Description
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, 9 months
Title
Brain morphometry
Description
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 months
Title
Blood markers
Description
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
Title
Heart rate variability
Description
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
Title
Beck Anxiety Inventory (BAI)
Description
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
Title
Symbol Digit Modalities Test (SDMT)
Description
This is an oral version of the Digit Symbol Substitution Test
Time Frame
baseline, 3, 6, 9 months
Title
The Stroop Color and Word Test (SCWT)
Description
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
Title
Trail-making Test A and B
Description
This is a test of speeded visual search, vigilance, and set-shifting.
Time Frame
baseline, 3, 6, 9 months
Title
Controlled Oral Word Association Test, Category Fluency and Category Switching
Description
These are tests of rapid word retrieval, cognitive flexibility, and semantic access/semantic network integrity.
Time Frame
baseline, 3, 6, 9 months
Title
Patient Reported Outcomes Measurement Information System - Cognition Function and ability subset
Description
The PROMIS Cognitive Function and Cognitive Function Abilities Subset item banks assess patient-perceived cognitive deficits
Time Frame
baseline, 3, 6, 9 months
Title
The California Verbal Learning Test-II (CVLT-II)
Description
CVLT-II is a comprehensive assessment of verbal learning and memory available for older adolescents and adults.
Time Frame
baseline, 3, 6, 9 months
Title
Modified Brief Pain Inventory (BPI)
Description
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
Title
Brief Quantitative Sensory Testing (QST)
Description
QST will include mechanical and heat pain threshold and tolerance measurements
Time Frame
baseline, 3, 6, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Eshel
Phone
617-726-5004
Email
meshel@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Kong
Phone
617-7267893
Email
jkong2@mgh.harvard.edu
Facility Information:
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Kong
Phone
617-726-7893
Email
jkong2@partner.org
First Name & Middle Initial & Last Name & Degree
Jian Kong

12. IPD Sharing Statement

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Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline

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