Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline

NCT ID: NCT04009382

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2025-02-06

Brief Summary

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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

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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

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Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Baduanjin Exercise

Intervention Type OTHER

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

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).

Group Type ACTIVE_COMPARATOR

Cognitive Fitness Program

Intervention Type OTHER

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

Interventions

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Baduanjin Exercise

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

Intervention Type OTHER

Cognitive Fitness Program

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian Kong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Charlestown, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2018P001997

Identifier Type: -

Identifier Source: org_study_id

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