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

March 13, 2019 updated by: Samsung Medical Center

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine
        • Contact:
        • Contact:
          • Sang Won Seo, MD. PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cortical thickiness in 3D MRI
Time Frame: One year after receiving muscle relaxation massage everyday.
changes of cerebral cortical thickness in 3D MRI
One year after receiving muscle relaxation massage everyday.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year after receiving muscle relaxation massage everyday.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Sang Won Seo, MD, PhD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2017

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

April 15, 2018

First Submitted That Met QC Criteria

April 15, 2018

First Posted (Actual)

April 24, 2018

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-05-135

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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