Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT03903328
Status:
COMPLETED
Last Update Posted:
2019-04-04
First Post:
2019-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Sarcopenia Among Elderly Living in Care Facilities in Klang Valley, Malaysia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001827', 'term': 'Body Height'}, {'id': 'D018737', 'term': 'Hand Strength'}, {'id': 'D000072797', 'term': 'Walking Speed'}], 'ancestors': [{'id': 'D049628', 'term': 'Body Size'}, {'id': 'D001837', 'term': 'Body Weights and Measures'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000067029', 'term': 'Physical Appearance, Body'}, {'id': 'D000886', 'term': 'Anthropometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006128', 'term': 'Growth'}, {'id': 'D048788', 'term': 'Growth and Development'}, {'id': 'D053580', 'term': 'Muscle Strength'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D005684', 'term': 'Gait'}, {'id': 'D016138', 'term': 'Walking'}, {'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2019-04-02', 'studyFirstSubmitQcDate': '2019-04-02', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skeletal muscle mass', 'timeFrame': '10 minutes', 'description': 'The skeletal muscle mass was measured using a Research grade Segmental BioImpedance Analyser to help derive the skeletal muscle mass index (Appendicular skeletal muscle mass/square of height= kg/m2)'}, {'measure': 'Grip strength', 'timeFrame': '1 minute to 10 minutes', 'description': 'Measurement of muscle strength was done using a Jamar hydraulic handheld dynamometer, only one maximal effort was allowed. However, for erroneous performance another attempt was provided after 10 minutes of rest. The measure was recorded in Kgf.'}, {'measure': 'Gait speed', 'timeFrame': 'less the 10 minutes on an average', 'description': 'Usual gait speed was used as a measure of physical performance, where the subject was required to walk along a 5 meter straight path. Time recorded using a stopwatch and speed recorded in meters per second'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['muscle strength', 'physical performance', 'Sarcopenia'], 'conditions': ['Sarcopenia', 'Sarcopenic Obesity']}, 'referencesModule': {'references': [{'pmid': '21371760', 'type': 'BACKGROUND', 'citation': 'Abizanda P, Navarro JL, Garcia-Tomas MI, Lopez-Jimenez E, Martinez-Sanchez E, Paterna G. Validity and usefulness of hand-held dynamometry for measuring muscle strength in community-dwelling older persons. Arch Gerontol Geriatr. 2012 Jan-Feb;54(1):21-7. doi: 10.1016/j.archger.2011.02.006. Epub 2011 Mar 2.'}, {'type': 'BACKGROUND', 'citation': 'Abridged Life Tables, Malaysia, 2012-2015. (2015). Department of Statistics Malaysia. Retrieved from: https://www.statistics.gov.my/index.php?r=column/pdfPrev&id=cWxzRWcvMTZrWFp4UStqQmp3MG9QZz09'}, {'pmid': '24450555', 'type': 'BACKGROUND', 'citation': 'Arai H, Akishita M, Chen LK. Growing research on sarcopenia in Asia. Geriatr Gerontol Int. 2014 Feb;14 Suppl 1:1-7. doi: 10.1111/ggi.12236. No abstract available.'}, {'pmid': '24461239', 'type': 'BACKGROUND', 'citation': 'Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.'}, {'pmid': '20392703', 'type': 'BACKGROUND', 'citation': 'Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.'}, {'pmid': '25241753', 'type': 'BACKGROUND', 'citation': 'Cruz-Jentoft AJ, Landi F, Schneider SM, Zuniga C, Arai H, Boirie Y, Chen LK, Fielding RA, Martin FC, Michel JP, Sieber C, Stout JR, Studenski SA, Vellas B, Woo J, Zamboni M, Cederholm T. Prevalence of and interventions for sarcopenia in ageing adults: a systematic review. Report of the International Sarcopenia Initiative (EWGSOP and IWGS). Age Ageing. 2014 Nov;43(6):748-59. doi: 10.1093/ageing/afu115. Epub 2014 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of this study was to investigate the prevalence of age-related progressive decline in muscle mass and strength (Sarcopenia) among Malaysian elderly residing in long-term care facilities. It is a very important condition to study as it is associated with high incidence of fall, hospitalization and mortality.', 'detailedDescription': 'Over the past few decades, one condition that prominently affects the muscular system, known as sarcopenia, has captured the attention of healthcare experts and researchers. Sarcopenia is a geriatric syndrome characterized by the involuntary, gradual and generalized deterioration of skeletal muscle mass and strength with advancing age. It is to be noted that while sarcopenia is predominantly a syndrome of the elderly, its development may also be observed in various conditions such as disuse, malnutrition and cachexia, all of which are not exclusive only to the elderly. As of now, there are still ongoing research on an international scale with regards to its epidemiology, risk factors, causative factors, adverse clinical complications, prevention and treatment.\n\nBeginning in 1st of October, 2016, Centres for Disease Control and Prevention (CDC) has finally officialised an International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10- CM) code for sarcopenia after its final proposal since April 2015. This establishment has enabled comprehensible clinical guidelines for diagnosis and treatment of sarcopenia, as well as separate reporting and data collection for sarcopenia in the medical community.\n\nIn essence, sarcopenia appears to be one of the most important causes of functional impairment, physical disability and loss of independence in older adults and a prevalence study will help to estimate the deleterious effects of this condition on the elderly living in the care facility, who happen to be the less privileged group as compared to their counterparts dwelling in the community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly living in long-term care facilities (Institutionalized elderly) in Klang valley. Only Seven facilities allowing access to the study subjects were studied', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Currently residing in a long-term care facility\n* Ability to walk, with or without the use of any walking aid\n* Citizen of Malaysia\n\nExclusion Criteria:\n\n* Inability to stand for height, weight and gait speed assessments\n* Presence of cardiac pacemaker\n* Presence of artificial limbs / prosthesis / metal implants\n* Difficult or dangerous behaviours\n* Severe cardiac, pulmonary, or musculoskeletal disorders\n* Severe cognitive impairment or any disability that makes communication impossible\n* Presence of terminal illness\n* Co-morbidities associated with high risk of falls (e.g. Parkinson's disease or CVA) or that may directly influence affect gait speed"}, 'identificationModule': {'nctId': 'NCT03903328', 'briefTitle': 'Prevalence of Sarcopenia Among Elderly Living in Care Facilities in Klang Valley, Malaysia', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Tunku Abdul Rahman'}, 'officialTitle': 'A Preliminary Study of Prevalence of Sarcopenia Among Elderly Living in Care Facilities in Klang Valley, Malaysia', 'orgStudyIdInfo': {'id': 'U/SERC/77/2016'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sarcopenia assessment', 'type': 'OTHER', 'otherNames': ['Height and weight measurements', 'Skeletal muscle mass index', 'Hand grip strength', 'Gait speed'], 'description': 'Sarcopenia assessment by measurement of Skeletal Muscle mass index, hand grip strength and usual gait speed for 5 meter distance, as per the guidelines of Asia Working group for Sarcopenia study, was carried out.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'PRAMOD D SHENOY, MPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Tunku Abdul Rahman'}, {'name': 'sook Fan Yap, FRCP (UK)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universiti Tunku Abdul Rahman'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Tunku Abdul Rahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Physiotherapy and Senior Lecturer', 'investigatorFullName': 'Pramod Divakara Shenoy, MPT', 'investigatorAffiliation': 'Universiti Tunku Abdul Rahman'}}}}