NCT04009382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 31, 2020

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2025

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

4.4 years

First QC Date

July 1, 2019

Last Update Submit

May 28, 2025

Conditions

Cognitive Decline

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (14)

  • Everyday Cognition -Subject/Self Report Form (ECog-self report and informant)

    baseline, 3, 6, 9 months

  • Patient Reported Outcomes Measurement Information System 29 (PROMIS-29)

    baseline, 3, 6, 9 months

  • Brain morphometry

    baseline, 3, 6 months

  • Blood markers

    baseline, 3, 6, 9 months

  • Heart rate variability

    baseline, 3, 6, 9 months

  • +9 more secondary outcomes

Study Arms (2)

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).

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).

Other: Cognitive Fitness Program

Interventions

Baduanjin ExerciseOTHER

Subjects will participate in Baduanjin, a simple mind-body exercise, for 24 weeks.

Baduanjin
Cognitive Fitness ProgramOTHER

Subjects will complete paper puzzles (Sudoku, crosswords, etc.) for 24 weeks.

Cognitive Fitness Program

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

August 31, 2020

Primary Completion

February 6, 2025

Study Completion

February 6, 2025

Last Updated

June 3, 2025

Record last verified: 2025-05

Locations

US(1)