Condition or disease | Intervention/treatment | Phase |
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Cognitive Decline | Other: Baduanjin Exercise Other: Cognitive Fitness Program | Not Applicable |
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 : | 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 |
Arm | Intervention/treatment |
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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).
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Other: Baduanjin Exercise
Subjects will participate in Baduanjin, a simple mind-body exercise, for 24 weeks.
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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).
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Other: Cognitive Fitness Program
Subjects will complete paper puzzles (Sudoku, crosswords, etc.) for 24 weeks.
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Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nathaniel Meshberg | 617-726-5004 | nmeshberg@mgh.harvard.edu |
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 |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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 |
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Condition ICMJE | Cognitive Decline | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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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 |
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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 |