Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-26 @ 9:06 PM
Study NCT ID:
NCT03507192
Status:
UNKNOWN
Last Update Posted:
2019-03-14
First Post:
2018-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2018-04-15', 'studyFirstSubmitQcDate': '2018-04-15', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cortical thickiness in 3D MRI', 'timeFrame': 'One year after receiving muscle relaxation massage everyday.', 'description': 'changes of cerebral cortical thickness in 3D MRI'}], 'secondaryOutcomes': [{'measure': 'functional connectivity in functional MRI', 'timeFrame': 'One year after receiving muscle relaxation massage everyday.', 'description': 'functional connectivity of default mode network in and resting state fMRI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["MCI, Alzheimer's disease, muscle relaxation"], 'conditions': ['Mild Cognitive Impairment', 'Alzheimer Dementia']}, 'referencesModule': {'references': [{'pmid': '34296549', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nTherefore, 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.", 'detailedDescription': "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.\n\nStress 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.\n\nThere 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.\n\nMuscle 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.\n\nTherefore, 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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\n2. 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.)'}, 'identificationModule': {'nctId': 'NCT03507192', 'briefTitle': 'Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia.', 'orgStudyIdInfo': {'id': '2017-05-135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm 1', 'description': '30 subjects In arm 1, no intervention is performed.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': '30 patients In arm 2 , active comparators, Muscle relaxation using full body massage machine is performed every morning and evening for 30 minutes.', 'interventionNames': ['Device: Muscle relaxation using full body massage machine']}], 'interventions': [{'name': 'Muscle relaxation using full body massage machine', 'type': 'DEVICE', 'description': 'Receiving muscle relaxation machine massage every morning and evening for 30 minutes during a year', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Won Seo, MD. PhD.', 'role': 'CONTACT'}, {'name': 'Young Hee Jung, MD', 'role': 'CONTACT', 'email': 'neophilia1618@gmail.com', 'phone': '+82-10-6755-5462'}], 'facility': 'Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sang Won Seo, MD, PhD', 'role': 'CONTACT', 'email': 'sangwonseo@empal.com', 'phone': '+82-2-3410-1233'}, {'name': 'Young Hee Jung, MD', 'role': 'CONTACT', 'email': 'neophilia1618@gmail.com', 'phone': '+82-10-6755-5462'}], 'overallOfficials': [{'name': 'Sang Won Seo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}