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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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?
Yes, posted in the registrySummary in the doctors' view

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

Other trials in United States

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.

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 groups in NCT04009382
Study groupRoleWhat they receive
BaduanjinExperimentalThis 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 ProgramActive comparatorThis 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.

  1. Alzheimer Disease Cooperative Study- Preclinical Alzheimer (ADCS-PACC) Cognitive Composite

    The ADCS-PACC is a composite of well-validated neuropsychological tests selected for their sensitivity to detect the earliest cognitive decline from normal to subtly abnormal performance. In this study, the ADCS-PACC will be reported as a z-transformed composite score, where a z-score of 0 represents the reference population mean and each 1.0 z-score unit corresponds to one standard deviation (SD) from that mean. Higher (more positive) z-scores indicate better cognitive performance, whereas lower (more negative) z-scores indicate worse cognitive performance. We will interpret changes over time as standardized change in global cognition. We reported the change from baseline to 6 months because this is the study's primary timepoint (end of intervention).

    Measured: baseline, 3, 6, 9 months

  2. Functional Connectivity of Hippocampus and DLPFC

    Resting-state functional connectivity (rsFC) between the hippocampus and the dorsolateral prefrontal cortex (DLPFC) will be quantified from resting-state functional magnetic resonance imaging (rs-fMRI) data. Specifically, we will compute the correlation between the hippocampal seed time series and the time series from a right DLPFC region of interest (ROI), and report connectivity as a Fisher r-to-z-transformed correlation coefficient (zFC) to support statistical inference. Higher (more positive) zFC values indicate stronger positive coupling, values near 0 indicate little to no coupling, and negative values indicate anticorrelation between regions. In typical rs-fMRI data, Fisher z-transformed connectivity values generally fall within an interpretable range of approximately -0.5 to +0.5. We reported the change from baseline to 6 months because this is the study's primary timepoint (end of intervention) and the prespecified primary endpoint.

    Measured: baseline, 3, 6 months

Secondary outcomes (14)
  1. The Everyday Cognition - Participant Report Form (ECog) - Everyday Memory Domain

    The Everyday Cognition - Participant Report Form (ECog) - Everyday Memory domain is an 8-item self-report measure of perceived changes in everyday memory functioning compared with the participant's functioning approximately 10 years earlier. Each item is rated on a 4-point scale ranging from 1 (better or no change) to 4 (consistently much worse). The Everyday Memory domain score is calculated as the average of the completed item scores and ranges from 1 to 4. Higher scores indicate greater perceived decline in everyday memory functioning and represent a worse outcome, while lower scores indicate less perceived decline and represent a better outcome. Here we report the change in this score from baseline to the post-treatment assessment (post-treatment (6 month) - baseline).

    Measured: baseline, 3, 6, 9 months

  2. Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)

    PROMIS-29 domain subscore is used to assess Physical Function (includes 4 items). Physical Function score ranges from 4-20 (higher = better function). We report the change in Physical Function from baseline to 6 months as the pre-specified primary time point.

    Measured: baseline, 3, 6, 9 months

  3. Brain Morphometry

    We will quantify bilateral hippocampal volume at baseline and Month 6 (end of intervention) and report the change (Month 6 - baseline). Volumes will be reported in mm³ (and, if applicable, normalized to total intracranial volume). Higher volume indicates greater structural integrity; decreases indicate atrophy. Values are non-negative and typically ~2,000-5,000 mm³ per hemisphere in adults (method- and age-dependent). We will report the observed mean change scores (Δmm³).

    Measured: baseline, 3, 6 months

  4. Blood Markers

    p-tau217 (Tau 217) is a blood/CSF biomarker closely linked to Alzheimer's pathology, rising early with amyloid and increasing further with tau tangle burden. "Normal range" is assay-specific; amyloid-negative values are often ~0.2 pg/mL, with rule-in/abnormal cutoffs commonly ~0.33 pg/mL (plus a gray zone).

    Measured: baseline, 3, 6, 9 months

  5. Heart Rate Variability

    Secondary autonomic endpoints from a 5-min ECG included RMSSD. We report change from baseline to 6 months (6-month minus baseline) because 6 months was the prespecified primary time point (end of the intervention), intended to capture more sustained effects while reducing short-term variability/attrition. RMSSD (ms) is non-negative (0 to unbounded) and is commonly used as an index of parasympathetic/vagal modulation.

    Measured: baseline, 3, 6, 9 months

  6. Beck Anxiety Inventory (BAI)

    The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety symptom severity over the past week. Total scores range from 0 to 63 (higher scores indicate greater anxiety). We evaluated change from baseline to month 6, the end of the intervention.

    Measured: baseline, 3, 6, 9 months

  7. Symbol Digit Modalities Test (SDMT)

    The Symbol Digit Modalities Test (SDMT) is a brief, well-validated measure of processing speed, attention, and visual scanning. Performance is typically the number of correct symbol-digit pairings completed within the time limit (commonly 90 seconds), with scores ranging from 0 to 110 (higher is better). We evaluated change from baseline to month 6, the end of the intervention.

    Measured: baseline, 3, 6, 9 months

  8. The Stroop Color and Word Test (SCWT)

    The Stroop Color and Word Test (SCWT) is a widely used measure of selective attention, processing speed, and inhibitory control. Specifically, it measures the ability to suppress the automatic tendency to read a word rather than name the ink color. The slowing in performance caused by this conflict is called Stroop interference. The interference score is often calculated as the additional time required to complete the incongruent color-word condition relative to a baseline (neutral or congruent) condition, with lower time indicating better performance. Scores range from approximately 0 seconds (no interference) to an unbounded upper limit constrained by test duration. We report the change in interference score from post-treatment to baseline.

    Measured: baseline, 3, 6, 9 months

  9. Trail Making Test Parts A and B Set-Shifting Cost

    The Trail Making Test (TMT) Parts A and B measure processing speed, attention, and executive function. Part A assesses visual scanning and speeded sequencing, while Part B additionally requires set-shifting between numbers and letters. Performance on each part is measured as completion time in seconds, with shorter completion times indicating better performance. The outcome reported is the set-shifting cost, calculated as (TMT Part B completion time - TMT Part A completion time)/(TMT Part B completion time + TMT Part A completion time). This is intended to quantify the additional time required for the executive set-shifting demands of Part B while accounting for individual differences in overall processing speed. Lower values indicate better executive performance, whereas higher values indicate worse executive performance. The measure has no established clinical cutoff or threshold values. We report the change in set-shifting cost from baseline to post-treatment.

    Measured: baseline, 3, 6, 9 months

  10. Controlled Oral Word Association Test, Category Fluency and Category Switching

    The Controlled Oral Word Association Test (COWAT), Category Fluency, and Category Switching assess verbal fluency and executive control (letter-based word generation, semantic word generation, and switching between categories). Participants are asked to alternately generate words belonging to two semantic categories during a timed trial. Scores are typically the number of correct, non-repeated words produced within the timed trial(s) (practical range 0 to >40, with higher scores indicating better performance). There are no established clinical threshold or cutoff values for this measure. We evaluated change from baseline to month 6.

    Measured: baseline, 3, 6, 9 months

  11. Patient Reported Outcomes Measurement Information System - Cognition Function and Ability Subset

    The PROMIS® Cognitive Function and Cognitive Function-Abilities item banks assess patient-reported cognitive concerns and perceived cognitive abilities (e.g., memory, attention, mental clarity). Scores are typically reported as T-scores standardized to the U.S. general population (mean 50, SD 10), with higher scores indicating better perceived cognitive function/abilities. We evaluated change from baseline to month 6, the end of the intervention.

    Measured: baseline, 3, 6, 9 months

  12. The California Verbal Learning Test-II (CVLT-II)

    The California Verbal Learning Test-II (CVLT-II) is a standardized measure of verbal learning and episodic memory for adolescents and adults. The Short-Delay Free Recall trial assesses the ability to recall a word list approximately 2 minutes after completion of the learning phase. Results are reported as age-adjusted Z-scores based on published normative data. A Z-score of 0 represents the normative population mean, positive Z-scores indicate performance above the population mean (better memory performance), and negative Z-scores indicate performance below the population mean (worse memory performance). There are no universally accepted clinical cutoff values for this outcome. We report the change in Short-Delay Free Recall Z-score from baseline to month 6 (end of the intervention).

    Measured: baseline

  13. Modified Brief Pain Inventory (BPI)

    The Brief Pain Inventory (BPI) is a 15-item questionnaire that assesses pain location, intensity, relief, quality, and pain-related interference with daily functioning and quality of life. Here, we report average pain over the past week on a 0-10 numeric rating scale. Lower scores indicate less pain (better outcome) and higher scores indicate more pain (worse outcome). We analyzed change from baseline to month 6, which is the end of the study, and included only participants reporting pain (i.e., BPI average pain ≥ 1).

    Measured: baseline, 3, 6, 9 months

  14. Brief Quantitative Sensory Testing (QST)

    Quantitative sensory testing (QST) will be assessed from baseline to month 6, which represents the end of the intervention. QST will include mechanical and heat pain measures, specifically pain threshold and pain tolerance. Expected values can vary by test location/body site (e.g., face vs forearm), as well as participant and contextual factors such as age, sex, skin characteristics, and testing conditions.

    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.

  1. First posted5 Jul 2019
  2. Study start31 Aug 2020
  3. Primary completion6 Feb 2025
  4. Study completion6 Feb 2025

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04009382
Sponsor's protocol ID
2018P001997
Acronym
BDJ
Status last verified
Nov 2026
First submitted
1 Jul 2019
Last updated
6 Nov 2026
FDA-regulated drug
No
FDA-regulated device
No

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 6 Nov 2026. 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?

Yes. Results are posted in the registry (first posted 6 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 6 Nov 2026.

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