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

Not Applicable

• Conditions: Mild Cognitive Impairment; Alzheimer Dementia
• Interventions: Device: Muscle relaxation using full body massage machine

• Registration Number: NCT03507192
• Lead Sponsor: Samsung Medical Center

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-25
• Status Verified: 2018-04
• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-04-15
• Study First Posted: 2018-04-24
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-14
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Muscle relaxation using full body massage machine	30 patients In arm 2 , active comparators, Muscle relaxation using full body massage machine is performed every morning and evening for 30 minutes.

Primary Outcome Measures

Name	Time	Method
cortical thickiness in 3D MRI	One year after receiving muscle relaxation massage everyday.	changes of cerebral cortical thickness in 3D MRI

Secondary Outcome Measures

Name	Time	Method
functional connectivity in functional MRI	One year after receiving muscle relaxation massage everyday.	functional connectivity of default mode network in and resting state fMRI

Trial Locations

Locations (1)

Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine; 🇰🇷 Seoul, Korea, Republic of