Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.
1 other identifier
interventional
60
1 country
1
Brief Summary
Muscle relaxation has been reported to be effective in alleviating anxiety and agitation symptoms in patients with dementia, but no studies have examined the effects of muscle relaxation therapy on cognitive function changes. Therefore, the purpose of this study is to compare and validate the improvement of cognitive function in patients with mild cognitive impairment and early alzheimer's dementia aged 50 to 85 years after performing muscle relaxation machine massage regularly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
September 25, 2017
CompletedFirst Submitted
Initial submission to the registry
April 15, 2018
CompletedFirst Posted
Study publicly available on registry
April 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMarch 14, 2019
April 1, 2018
2.3 years
April 15, 2018
March 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cortical thickiness in 3D MRI
changes of cerebral cortical thickness in 3D MRI
One year after receiving muscle relaxation massage everyday.
Secondary Outcomes (1)
functional connectivity in functional MRI
One year after receiving muscle relaxation massage everyday.
Study Arms (2)
Arm 1
NO INTERVENTION30 subjects In arm 1, no intervention is performed.
Arm 2
ACTIVE COMPARATOR30 patients In arm 2 , active comparators, Muscle relaxation using full body massage machine is performed every morning and evening for 30 minutes.
Interventions
Receiving muscle relaxation machine massage every morning and evening for 30 minutes during a year
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 06351, South Korea
Related Publications (1)
Kim YJ, Kim HR, Jung YH, Park YH, Seo SW. Effects of Electrical Automatic Massage on Cognition and Sleep Quality in Alzheimer's Disease Spectrum Patients: A Randomized Controlled Trial. Yonsei Med J. 2021 Aug;62(8):717-725. doi: 10.3349/ymj.2021.62.8.717.
PMID: 34296549DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Won Seo, MD, PhD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2018
First Posted
April 24, 2018
Study Start
September 25, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
March 14, 2019
Record last verified: 2018-04