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SarcopeniaNCT03903328

Prevalence of Sarcopenia Among Elderly Living in Care Facilities in Klang Valley, Malaysia

An observational study of Sarcopenia and Sarcopenic Obesity, run by Universiti Tunku Abdul Rahman.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Sarcopenic Obesity
What is being tested?
Sarcopenia assessment
How many people
205 participants
Where
No sites listed yet
Study dates
6 Dec 2016to 4 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

About this study

Official title: A Preliminary Study of Prevalence of Sarcopenia Among Elderly Living in Care Facilities in Klang Valley, Malaysia

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.

Read the detailed description

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.

Beginning 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.

In 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.

Being tested
Sarcopenia assessment
Keywords
muscle strength, physical performance, Sarcopenia
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sarcopenia assessmentOther

    Also called Height and weight measurements, Skeletal muscle mass index, Hand grip strength, Gait speed

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 10 minutes

  2. 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.

    Measured: 1 minute to 10 minutes

  3. 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

    Measured: less the 10 minutes on an average

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2019
  2. Study start6 Dec 2016
  3. Primary completion4 Dec 2017
  4. Study completion4 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03903328
Sponsor's protocol ID
U/SERC/77/2016
Status last verified
Apr 2019
First submitted
2 Apr 2019
Last updated
4 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21371760

  • 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

  • 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.

    PubMed 24450555

  • 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.

    PubMed 24461239

  • 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.

    PubMed 20392703

  • 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.

    PubMed 25241753

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Sarcopenic Obesity, run by Universiti Tunku Abdul Rahman.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skeletal muscle mass (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03903328, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.

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