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Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03507192
Recruitment Status : Unknown
Verified April 2018 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : April 24, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer Dementia Device: Muscle relaxation using full body massage machine Not Applicable

Detailed Description:

The prevalence of dementia is approximately 5-10% in the elderly who are over 65 years of age. In Korea, the prevalence of dementia among elderly people aged 65 and over was 9.18% in 2012, and the number of patients with dementia was estimated to be 540,755 (155,955 for male, 384,800 for female). The number of patients with dementia will be doubled every 20 years until 2050, which is estimated to be 840,000 in 2020, about 1.27 million in 2030, and 2.71 million in 2050. Alzheimer's disease is the most common cause of dementia, accounting for 55-70% of all dementia. Major risk factors include age, genetic factors, apolipoprotein E gene, female and brain trauma, but stress is also associated with increased risk of Alzheimer's disease.

Stress can be present anywhere in our daily lives, and stress can energize life, but if people are exposed to stress for a long time, they may develop physical symptoms. Severe and long-term stress can cause or exacerbate diseases such as angina, stroke, hypertension, diabetes, tension headache, back pain, irritable bowel syndrome, asthma and arthritis. Studies about the relationship between stress and Alzheimer's disease have shown that the corticotrophin releasing factor secreted when exposed to stress can increase brain toxic protein such as beta amyloid plaques that are known to be responsible for dementia.

There are various ways to overcome stress, like meditation, yoga and relaxation training methods that individuals can do at home. Relaxation training methods include relaxation using breathing and progressive muscle relaxation. Progressive muscle relaxation therapy stabilizes anxious psychology by stretching and relaxing several muscles of the body in turn. Muscle relaxation promotes arterial and venous flow, lymphatic flow, reduces edema of muscles and connective tissues, and improves organ function to aid homeostasis.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Arm 1
30 subjects In arm 1, no intervention is performed.
Active Comparator: Arm 2
30 patients In arm 2 , active comparators, Muscle relaxation using full body massage machine is performed every morning and evening for 30 minutes.
 Device: Muscle relaxation using full body massage machine
Receiving muscle relaxation machine massage every morning and evening for 30 minutes during a year


Outcome Measures
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Primary Outcome Measures :
  1. cortical thickiness in 3D MRI [ Time Frame: One year after receiving muscle relaxation massage everyday. ]
    changes of cerebral cortical thickness in 3D MRI


Secondary Outcome Measures :
  1. functional connectivity in functional MRI [ Time Frame: One year after receiving muscle relaxation massage everyday. ]
    functional connectivity of default mode network in and resting state fMRI


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Inclusion Criteria (1) Subjects aged 50 to 85 years who understand and agree to the purpose of the study (2) mild cognitive impairment or early stage of Alzheimer dementia (3) CDR of 0.5~1
  2. Exclusion Criteria (1) severe cerebral white matter hyperintensities on brain MRI : defined as deep white matter ≥ 2.5 cm, caps or band ≥ 1.0 cm (2) cancer or severe medical illness (3) fear of magnetic resonance imaging (MRI) examination (claustrophobia) (4) MRI contrast agent side effects (4) pacemaker or a metal material which can not be detached (prosthetics, braces, etc.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507192


Contacts
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Contact: Sang Won Seo, MD, PhD +82-2-3410-1233 sangwonseo@empal.com
Contact: Young Hee Jung, MD +82-10-6755-5462 neophilia1618@gmail.com

Locations
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Korea, Republic of
Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine Recruiting
Seoul, Korea, Republic of, 06351
Contact: Sang Won Seo, MD. PhD.         
Contact: Young Hee Jung, MD    +82-10-6755-5462    neophilia1618@gmail.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Sang Won Seo, MD, PhD Samsung Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03507192    
Other Study ID Numbers: 2017-05-135
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samsung Medical Center:
MCI, Alzheimer's disease, muscle relaxation
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Cognition Disorders