4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline (BDJ)

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

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.

Condition or disease Intervention/treatment Phase
Cognitive Decline Other: Baduanjin Exercise Other: Cognitive Fitness Program Not Applicable

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. In a previous study, the investigators found that BDJ significantly improved memory and executive function, resting state functional connectivity of the hippocampus and dorsolateral prefrontal cortex, and grey matter volume of the medial temporal area and putamen in older adults. In addition, the investigators found that BDJ could produce significantly greater cognitive function improvement, as measured by the Wechsler Memory Scale (WMS) sub-score, and more extensive grey matter brain volume changes at medial temperal lobe and putamen. A more recent pilot study showed that, compared to walking and health education, six months of BDJ significantly improved cognitive function in patients with MCI. These findings provide a solid foundation for the current application.

This proposal aims to investigate 1) the preventative effect of longitudinal BDJ on cognitive decline, 2) the modulation effect of BDJ on resting state functional connectivity of the hippocampus and bilateral dorsolateral prefrontal cortex, and 3) the modulation effect of BDJ on brain morphometry in individuals with SCD as compared to controls. The investigators 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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : June 30, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: Baduanjin Group
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
Subjects will participate in Baduanjin, a simple mind-body exercise, for 24 weeks.

Active Comparator: Control Group
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
Subjects will complete paper puzzles (Sudoku, crosswords, etc.) for 24 weeks.

Outcome Measures
Primary Outcome Measures :
  1. ADCS-PACC [ Time Frame: 6 months ]
    The primary cognitive endpoint is the Alzheimer's Disease Cooperative Study-Preclinical Alzheimer Cognitive Composite (ADCS-PACC).

  2. Changes in resting state functional connectivity [ Time Frame: 6 months ]
    The primary imaging endpoint is to explore resting state functional connectivity of the hippocampus and dorsolateral prefrontal cortex (DLPFC), as measured by magnetic resonance imaging (MRI).

  3. Changes in grey matter volume [ Time Frame: 6 months ]
    The primary imaging endpoint is to assess brain grey matter volume changes using before and after BDJ exercise and magnetic resonance imaging (MRI).


Secondary Outcome Measures :
  1. NIH-TB [ Time Frame: 6 months ]
    The secondary endpoints include NIH Toolbox (NIH-TB) Cognition Battery, which measures cognitive, emotional, sensory, and motor functions.

  2. Memory Complaints Questionnaire (MAC-Q) [ Time Frame: 6 months ]
    The secondary endpoints include the Memory Complaints Questionnaire (MAC-Q), which measures subjective cognitive decline.

  3. Patient Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: 6 months ]
    The secondary endpoints include the Patient Reported Outcomes Measurement Information System (PROMIS-29), which measures physical, mental, and social health and wellbeing.

  4. Geriatric Depression Scale (GDS) [ Time Frame: 6 months ]
    The secondary endpoints include the Geriatric Depression Scale (GDS), which is a self-assessment that measures depression.

  5. CRP, proinflammatory cytokine IL-6, BDNF [ Time Frame: 6 months ]
    The secondary endpoints include measuring levels of C reactive protein (CRP), proinflammatory cytokine IL-6, and brain-derived neurotrophic factor (BDNF).

  6. LF/HF [ Time Frame: 6 months ]
    The secondary endpoints include measuring low frequency, high frequency, and LF to HF ratio (LF/HF) of heart rate variability as measured by ECG.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Nathaniel Meshberg 617-726-5004 nmeshberg@mgh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Jian Kong, MD, MPH    617-726-7893    jkong2@partner.org   
Principal Investigator: Jian Kong, MS, MPH         
Sponsors and Collaborators
Massachusetts General Hospital
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date May 11, 2021
Actual Study Start Date  ICMJE August 31, 2020
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • ADCS-PACC [ Time Frame: 6 months ]
    The primary cognitive endpoint is the Alzheimer's Disease Cooperative Study-Preclinical Alzheimer Cognitive Composite (ADCS-PACC).
  • Changes in resting state functional connectivity [ Time Frame: 6 months ]
    The primary imaging endpoint is to explore resting state functional connectivity of the hippocampus and dorsolateral prefrontal cortex (DLPFC), as measured by magnetic resonance imaging (MRI).
  • Changes in grey matter volume [ Time Frame: 6 months ]
    The primary imaging endpoint is to assess brain grey matter volume changes using before and after BDJ exercise and magnetic resonance imaging (MRI).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • NIH-TB [ Time Frame: 6 months ]
    The secondary endpoints include NIH Toolbox (NIH-TB) Cognition Battery, which measures cognitive, emotional, sensory, and motor functions.
  • Memory Complaints Questionnaire (MAC-Q) [ Time Frame: 6 months ]
    The secondary endpoints include the Memory Complaints Questionnaire (MAC-Q), which measures subjective cognitive decline.
  • Patient Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: 6 months ]
    The secondary endpoints include the Patient Reported Outcomes Measurement Information System (PROMIS-29), which measures physical, mental, and social health and wellbeing.
  • Geriatric Depression Scale (GDS) [ Time Frame: 6 months ]
    The secondary endpoints include the Geriatric Depression Scale (GDS), which is a self-assessment that measures depression.
  • CRP, proinflammatory cytokine IL-6, BDNF [ Time Frame: 6 months ]
    The secondary endpoints include measuring levels of C reactive protein (CRP), proinflammatory cytokine IL-6, and brain-derived neurotrophic factor (BDNF).
  • LF/HF [ Time Frame: 6 months ]
    The secondary endpoints include measuring low frequency, high frequency, and LF to HF ratio (LF/HF) of heart rate variability as measured by ECG.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline
Official Title  ICMJE Modulation Effects of Baduanjin Exercise on Subjective Cognitive Decline
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. In a previous study, the investigators found that BDJ significantly improved memory and executive function, resting state functional connectivity of the hippocampus and dorsolateral prefrontal cortex, and grey matter volume of the medial temporal area and putamen in older adults. In addition, the investigators found that BDJ could produce significantly greater cognitive function improvement, as measured by the Wechsler Memory Scale (WMS) sub-score, and more extensive grey matter brain volume changes at medial temperal lobe and putamen. A more recent pilot study showed that, compared to walking and health education, six months of BDJ significantly improved cognitive function in patients with MCI. These findings provide a solid foundation for the current application.

This proposal aims to investigate 1) the preventative effect of longitudinal BDJ on cognitive decline, 2) the modulation effect of BDJ on resting state functional connectivity of the hippocampus and bilateral dorsolateral prefrontal cortex, and 3) the modulation effect of BDJ on brain morphometry in individuals with SCD as compared to controls. The investigators 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cognitive Decline
Intervention  ICMJE
  • Other: Baduanjin Exercise
    Subjects will participate in Baduanjin, a simple mind-body exercise, for 24 weeks.
  • Other: Cognitive Fitness Program
    Subjects will complete paper puzzles (Sudoku, crosswords, etc.) for 24 weeks.
Study Arms  ICMJE
  • Experimental: Baduanjin Group
    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).
    Intervention: Other: Baduanjin Exercise
  • Active Comparator: Control Group
    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: Other: Cognitive Fitness Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2024
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nathaniel Meshberg 617-726-5004 nmeshberg@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009382
Other Study ID Numbers  ICMJE 2018P001997
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jian Kong, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Massachusetts General Hospital
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP