NCT07127692

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
323

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress82%
Sep 2025Jul 2026

First Submitted

Initial submission to the registry

August 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 10, 2025

Last Update Submit

August 16, 2025

Conditions

Keywords

Sarcopenia-promoting medicinesSarcopeniaFallsMedicines in elderly

Outcome Measures

Primary Outcomes (1)

  • Prevalence of exposure to one or more sarcopenia-promoting medication

    Proportion of adults aged 65 years and over attending the falls clinic who are prescribed one or more sarcopenia-promoting medication. Unit of measure: % of participants.

    6 months

Secondary Outcomes (7)

  • Distribution of sarcopenia-promoting medication classes

    6 months

  • Number of sarcopenia-promoting medications per participant

    6 months

  • Handgrip strength

    6 months

  • Gait speed

    6 months

  • SARC-F score

    6 months

  • +2 more secondary outcomes

Interventions

Hand grip strengthDIAGNOSTIC_TEST

Used to assess sarcopenia

Timed Up and Go testDIAGNOSTIC_TEST

Screening test for falls in elderly

Gait speedDIAGNOSTIC_TEST

Assessment to check for functional mobility and risk of falls.

Used to assess level of frailty.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted in a multidisciplinary falls clinic at Medway NHS Foundation Trust, based in Gillingham, Kent, England, UK. This secondary care setting receives referrals primarily from inpatient hospital teams and primary care practitioners. The clinic routinely assesses older adults who have experienced falls or are at high risk of falling, and conducts comprehensive geriatric assessments, including medication reviews, functional status evaluations, and frailty assessments.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medway NHS Foundation Trust

Gillingham, Kent, ME7 5NY, United Kingdom

Location

Related Publications (12)

  • 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.

  • Veronese, N., et al. (2020). Polypharmacy is associated with higher frailty risk in older people: A systematic review and meta-analysis. Journal of the American Medical Directors Association, 21(2), 181-187.

    RESULT
  • Tanskanen, A., et al. (2015). Anticholinergic burden and physical functioning in older people: A systematic review. Drugs & Aging, 32(10), 741-750.

    RESULT
  • 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.

  • Scott, D., et al. (2016). Sarcopenia and statin use: A potential link? Drugs & Aging, 33(1), 1-9.

    RESULT
  • 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

    RESULT
  • 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

    RESULT
  • Perlman C, Kirkham J, Velkers C, Leung RH, Whitehead M, Seitz D. Access to Psychiatrist Services for Older Adults in Long-Term Care: A Population-Based Study. J Am Med Dir Assoc. 2019 May;20(5):610-616.e2. doi: 10.1016/j.jamda.2019.01.121. Epub 2019 Mar 1.

  • Landi F, Liperoti R, Russo A, Giovannini S, Tosato M, Capoluongo E, Bernabei R, Onder G. Sarcopenia as a risk factor for falls in elderly individuals: results from the ilSIRENTE study. Clin Nutr. 2012 Oct;31(5):652-8. doi: 10.1016/j.clnu.2012.02.007. Epub 2012 Mar 11.

  • Fox C, Richardson K, Maidment ID, Savva GM, Matthews FE, Smithard D, Coulton S, Katona C, Boustani MA, Brayne C. Anticholinergic medication use and cognitive impairment in the older population: the medical research council cognitive function and ageing study. J Am Geriatr Soc. 2011 Aug;59(8):1477-83. doi: 10.1111/j.1532-5415.2011.03491.x. Epub 2011 Jun 24.

  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

  • Corsonello A, Pedone C, Incalzi RA. Age-related pharmacokinetic and pharmacodynamic changes and related risk of adverse drug reactions. Curr Med Chem. 2010;17(6):571-84. doi: 10.2174/092986710790416326.

MeSH Terms

Conditions

Sarcopenia

Interventions

Insemination, Artificial, HeterologousWalkingHand StrengthWalking Speed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insemination, ArtificialReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative TechniquesInseminationReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor ActivityMuscle StrengthPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisGait

Study Officials

  • Kamaldeep K Sahota, Pharmacist

    Medway NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamaldeep K Sahota, Pharmacist

CONTACT

Vikram Paranjyothi, Consultant Geriatrician

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead Clinical Pharmacist Frailty

Study Record Dates

First Submitted

August 10, 2025

First Posted

August 17, 2025

Study Start

September 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations