NCT03903328

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

April 2, 2019

Last Update Submit

April 2, 2019

Conditions

Keywords

muscle strengthphysical performanceSarcopenia

Outcome Measures

Primary Outcomes (3)

  • Skeletal muscle mass

    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)

    10 minutes

  • Grip strength

    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.

    1 minute to 10 minutes

  • Gait speed

    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

    less the 10 minutes on an average

Interventions

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.

Also known as: Height and weight measurements, Skeletal muscle mass index, Hand grip strength, Gait speed

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly living in long-term care facilities (Institutionalized elderly) in Klang valley. Only Seven facilities allowing access to the study subjects were studied

You may qualify if:

  • Currently residing in a long-term care facility
  • Ability to walk, with or without the use of any walking aid
  • Citizen of Malaysia

You may not qualify if:

  • Inability to stand for height, weight and gait speed assessments
  • Presence of cardiac pacemaker
  • Presence of artificial limbs / prosthesis / metal implants
  • Difficult or dangerous behaviours
  • Severe cardiac, pulmonary, or musculoskeletal disorders
  • Severe cognitive impairment or any disability that makes communication impossible
  • Presence of terminal illness
  • Co-morbidities associated with high risk of falls (e.g. Parkinson's disease or CVA) or that may directly influence affect gait speed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 21371760BACKGROUND
  • 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

    BACKGROUND
  • 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: 24450555BACKGROUND
  • 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: 24461239BACKGROUND
  • 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: 20392703BACKGROUND
  • 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.

    PMID: 25241753BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

Body HeightHand StrengthWalking Speed

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Body SizeBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Appearance, BodyAnthropometryInvestigative TechniquesPhysiological PhenomenaGrowthGrowth and DevelopmentMuscle StrengthMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaGaitWalkingLocomotionMovement

Study Officials

  • PRAMOD D SHENOY, MPT

    Universiti Tunku Abdul Rahman

    PRINCIPAL INVESTIGATOR
  • sook Fan Yap, FRCP (UK)

    Universiti Tunku Abdul Rahman

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Physiotherapy and Senior Lecturer

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 4, 2019

Study Start

December 6, 2016

Primary Completion

December 4, 2017

Study Completion

December 4, 2017

Last Updated

April 4, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share