Cognitive DeclineBDJNCT04009382
Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline
A study testing Baduanjin Exercise and Cognitive Fitness Program in people with Cognitive Decline, run by Massachusetts General Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Baduanjin Exercise and Cognitive Fitness Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 6 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
Official title: Modulation Effects of Baduanjin Mind-body Exercise on Subjective Cognitive Decline
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.
Read the 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.
- Conditions
- Cognitive Decline
- Being tested
- Baduanjin Exercise, Cognitive Fitness Program
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin ExerciseOther
Subjects will participate in Baduanjin, a simple mind-body exercise, for 24 weeks.
Cognitive Fitness ProgramOther
Subjects will complete paper puzzles (Sudoku, crosswords, etc.) for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin | Experimental | 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). Receives: Other: Baduanjin Exercise |
| Cognitive Fitness Program | Active comparator | 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). Receives: Other: Cognitive Fitness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, 3, 6 months
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline, 3, 6, 9 months
Symbol Digit Modalities Test (SDMT)
This is an oral version of the Digit Symbol Substitution Test
Measured: 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.
Measured: baseline, 3, 6, 9 months
Trail-making Test A and B
This is a test of speeded visual search, vigilance, and set-shifting.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline, 3, 6, 9 months
Brief Quantitative Sensory Testing (QST)
QST will include mechanical and heat pain threshold and tolerance measurements
Measured: baseline, 3, 6, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start31 Aug 2020
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Kong, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009382
- Sponsor's protocol ID
- 2018P001997
- Acronym
- BDJ
- Status last verified
- May 2025
- First submitted
- 1 Jul 2019
- Last updated
- 3 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation Effects of Baduanjin Mind-body Exercise on Subjective Cognitive Decline
- ClinicalTrials.gov ID
- NCT04009382
- Acronym / sponsor ID
- BDJ / 2018P001997
- Conditions
- Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baduanjin | Experimental | Other: Baduanjin ExerciseThis 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). |
| Cognitive Fitness Program | Active comparator | Other: Cognitive Fitness ProgramThis 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). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjin ExerciseSubjects will participate in Baduanjin, a simple mind-body exercise, for 24 weeks. | Other | Baduanjin |
| Cognitive Fitness ProgramSubjects will complete paper puzzles (Sudoku, crosswords, etc.) for 24 weeks. | Other | Cognitive Fitness Program |
Primary outcome
Alzheimer Disease Cooperative Study- Preclinical Alzheimer (ADCS-PACC) Cognitive Composite
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.
Functional connectivity of hippocampus and DLPFC
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.
14 secondary outcomes
Everyday Cognition -Subject/Self Report Form (ECog-self report and informant)
Time frame: baseline, 3, 6, 9 months
Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)
Time frame: baseline, 3, 6, 9 months
Brain morphometry
Time frame: baseline, 3, 6 months
Blood markers
Time frame: baseline, 3, 6, 9 months
Heart rate variability
Time frame: baseline, 3, 6, 9 months
Beck Anxiety Inventory (BAI)
Time frame: baseline, 3, 6, 9 months
Symbol Digit Modalities Test (SDMT)
Time frame: baseline, 3, 6, 9 months
The Stroop Color and Word Test (SCWT)
Time frame: baseline, 3, 6, 9 months
Trail-making Test A and B
Time frame: baseline, 3, 6, 9 months
Controlled Oral Word Association Test, Category Fluency and Category Switching
Time frame: baseline, 3, 6, 9 months
Patient Reported Outcomes Measurement Information System - Cognition Function and ability subset
Time frame: baseline, 3, 6, 9 months
The California Verbal Learning Test-II (CVLT-II)
Time frame: baseline, 3, 6, 9 months
Modified Brief Pain Inventory (BPI)
Time frame: baseline, 3, 6, 9 months
Brief Quantitative Sensory Testing (QST)
Time frame: baseline, 3, 6, 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin Exercise and Cognitive Fitness Program in people with Cognitive Decline, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer Disease Cooperative Study- Preclinical Alzheimer (ADCS-PACC) Cognitive Composite (time frame: baseline, 3, 6, 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.