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Enrolling by invitation NCT07127692

Prevalence of Sarcopenia-Promoting Medicines in Patients With Sarcopenia and Falls

Observational Sarcopenia in Elderly Falls

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire, Hand grip strength, Timed Up and Go test, Gait speed.
Who it may be relevant to
Registry conditions: Sarcopenia in Elderly, Falls. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Exploratory Study on the Prevalence of Sarcopenia-Promoting Medicines in Patients With Sarcopenia and Falls

Overview

Sarcopenia, characterised by the loss of muscle mass and function, is a common condition among the elderly and is often associated with increased risk of falls. Certain medications, such as glucocorticoids, statins, and some antipsychotics, may exacerbate sarcopenia, leading to a higher incidence of falls. This study aims to explore the prevalence of such medicines in patients diagnosed with sarcopenia who have experienced falls. Understanding the impact of these medications on sarcopenia and fall risk can inform clinical guidelines and improve patient outcomes.

Detailed description

Sarcopenia, the age-related loss of muscle mass and strength, is a recognised contributor to frailty, disability, and increased fall risk in older adults. While physical inactivity and comorbidities are known risk factors, increasing evidence suggests that certain medications - including corticosteroids, sedatives and statins - may also contribute to muscle decline. These medicines are frequently prescribed to older adults, but the extent of their use in patients with sarcopenia and falls remains poorly defined.

Falls clinics manage high-risk patients, yet there is currently limited research examining the prevalence of sarcopenia-promoting medications in this specific setting. This study addresses an important knowledge gap by estimating the prevalence of these medicines in older adults attending a secondary care falls clinic, and by exploring associations with sarcopenia and fall history.

The findings will support a better understanding of medication-related risk factors for sarcopenia and may help guide future deprescribing and medication review strategies. This aligns with current priorities in geriatric medicine to reduce inappropriate polypharmacy and improve outcomes for older adults through targeted, evidence-based prescribing.

Interventions

  • Diagnostic test Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire
    Self-administered screening tool for sarcopenia
  • Diagnostic test Hand grip strength
    Used to assess sarcopenia
  • Diagnostic test Timed Up and Go test
    Screening test for falls in elderly
  • Diagnostic test Gait speed
    Assessment to check for functional mobility and risk of falls.
  • Diagnostic test Clinical Frailty Scale (CFS)
    Used to assess level of frailty.

Primary outcome measures

  • Prevalence of exposure to one or more sarcopenia-promoting medication [Time frame: 6 months]
Secondary outcome measures (7)
  • Distribution of sarcopenia-promoting medication classes [Time frame: 6 months]
  • Number of sarcopenia-promoting medications per participant [Time frame: 6 months]
  • Handgrip strength [Time frame: 6 months]
  • Gait speed [Time frame: 6 months]
  • SARC-F score [Time frame: 6 months]
  • Timed Up and Go Test [Time frame: 6 months]
  • Association between medication burden and functional performance [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Aged ≥65 years
  • Attendance at the falls clinic for a new assessment
  • Diagnosed with sarcopenia (based on the European Working Group on Sarcopenia in Older People (EWGSOP2) criteria)
  • History of falls in the past 12 months

Exclusion criteria

  • Cognitive impairment preventing consent
  • Acute medical instability
  • Enrolled in on other clinical trials.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United Kingdom · 1 center
  • Medway NHS Foundation Trust — Gillingham

Publications

  • Zia A, Kamaruzzaman SB, Tan MP. Polypharmacy and falls in older people: Balancing evidence-based medicine against falls risk. Postgrad Med. 2015 Apr;127(3):330-7. doi: 10.1080/00325481.2014.996112. Epub 2014 Dec 24. PMID 25539567
  • Veronese N, Stubbs B, Noale M, Solmi M, Pilotto A, Vaona A, Demurtas J, Mueller C, Huntley J, Crepaldi G, Maggi S. Polypharmacy Is Associated With Higher Frailty Risk in Older People: An 8-Year Longitudinal Cohort Study. J Am Med Dir Assoc. 2017 Jul 1;18(7):624-628. doi: 10.1016/j.jamda.2017.02.009. Epub 2017 Apr 7. PMID 28396180
  • Tanskanen, A., et al. (2015). Anticholinergic burden and physical functioning in older people: A systematic review. Drugs & Aging, 32(10), 741-750.
  • Shafiee G, Keshtkar A, Soltani A, Ahadi Z, Larijani B, Heshmat R. Prevalence of sarcopenia in the world: a systematic review and meta- analysis of general population studies. J Diabetes Metab Disord. 2017 May 16;16:21. doi: 10.1186/s40200-017-0302-x. eCollection 2017. PMID 28523252
  • Scott, D., et al. (2016). Sarcopenia and statin use: A potential link? Drugs & Aging, 33(1), 1-9.
  • Reeve E, Wiese MD, Hendrix I, et al. (2014). The impact of deprescribing interventions on polypharmacy and clinical outcomes: a systematic review and meta-analysis. J Am Med Dir Assoc. 15(3):131-6. https://doi.org/10.1016/j.jamda.2013.11.008
  • Rawle MJ, Westbury LD, Russell S, et al (2018). Anticholinergic drug burden and cognitive function in people aged 50 years and older: the English Longitudinal Study of Ageing. Age Ageing; 47(4):505-11 https://doi.org/10.1093/ageing/afy026
  • Landi, F., et al. (2019). Polypharmacy and sarcopenia in older adults: A population-based study. Journal of the American Medical Directors Association, 20(5), 600-604.e7.

Identifiers

NCT: NCT07127692 · 354863

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗