Functional Muscle-Bone Incongruity Index (FKUI): A Prospective Observational Study (FKUI)
24. juni 2026 opdateret af: Dilek ün oguzhanasilturk, Kanuni Sultan Suleyman Training and Research Hospital
Functional Muscle-Bone Incongruity Index (FKUI): Combined Evaluation of Handgrip Strength, Total Hip Bone Mineral Density, and Lumbar-Hip Bone Mineral Density Discordance in Adults Undergoing DXA
The Functional Muscle-Bone Incongruity Index (FKUI) is a novel approach developed to evaluate the relationship between muscle function and bone health.
This prospective observational study aims to investigate the clinical applicability of FKUI, which combines handgrip strength, total hip bone mineral density (BMD), and lumbar-hip BMD discordance.
Approximately 200 adult participants undergoing routine DXA assessment will be enrolled.
The study will examine whether the combined evaluation of muscle function and bone health parameters provides a more comprehensive assessment of musculoskeletal status than individual measures alone.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
This is a prospective, observational, single-center study evaluating adults undergoing routine DXA assessment in a Physical Medicine and Rehabilitation outpatient clinic.
The study will investigate the clinical applicability of the Functional Muscle-Bone Incongruity Index (FKUI), a composite approach based on handgrip strength, total hip bone mineral density, and lumbar-hip bone mineral density discordance.
No treatment or interventional procedure will be administered as part of the study.
Handgrip strength will be measured using a calibrated hand dynamometer, and DXA-derived bone mineral density values will be recorded from routine clinical assessments.
The study aims to determine whether the combined evaluation of muscle function and bone health parameters may provide a more comprehensive assessment of musculoskeletal status.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Dilek Ün Oğuzhanasiltürk, MD
- Telefonnummer: +90 5056367184
- E-mail: dilekunoguzhan@gmail.com
Studiesteder
-
-
Istanbul
-
Küçükçekmece, Istanbul, Tyrkiet (Türkiye), 34303
- Rekruttering
- Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey
-
Kontakt:
- Dilek Ün Oğuzhanasiltürk, MD
- Telefonnummer: +905056367184
- E-mail: dilekunoguzhan@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The study population will consist of adults aged 18 years and older attending the Physical Medicine and Rehabilitation outpatient clinic who are scheduled to undergo routine dual-energy X-ray absorptiometry (DXA) assessment as part of their clinical evaluation.
Participants will be recruited consecutively from routine clinical practice.
The study aims to evaluate the relationship between muscle function and bone health through the Functional Muscle-Bone Incongruity Index (FKUI), which incorporates handgrip strength, total hip bone mineral density, and lumbar-hip bone mineral density discordance.
Beskrivelse
Inclusion Criteria:
- Age 18 years or older
- Attendance at the Physical Medicine and Rehabilitation outpatient clinic
- Scheduled to undergo routine bone mineral density assessment by DXA as part of clinical evaluation
- Ability to perform handgrip strength testing
- Availability of lumbar spine and total hip bone mineral density measurements suitable for analysis
- Ability and willingness to provide written informed consent
Exclusion Criteria:
Exclusion Criteria:
- Age younger than 18 years
- Secondary causes of osteoporosis (e.g., hyperparathyroidism, Cushing syndrome, malignancy, or other conditions affecting bone metabolism)
- History of metabolic bone disease
- Major trauma or fracture within the previous 6 months
- Upper extremity disorders that may significantly affect handgrip strength measurement (e.g., severe osteoarthritis, neurological disorders, major deformities)
- DXA measurements that are technically inadequate or unsuitable for analysis
- Refusal or inability to provide written informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Adults Undergoing Bone Mineral Density Evaluation
Adult patients attending the Physical Medicine and Rehabilitation outpatient clinic and undergoing routine DXA assessment as part of clinical evaluation.
Participants will undergo handgrip strength measurement and assessment of bone mineral density parameters.
The Functional Muscle-Bone Incongruity Index (FKUI) will be evaluated using handgrip strength, total hip bone mineral density, and lumbar-hip bone mineral density discordance.
No treatment or interventional procedure will be administered.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Muscle-Bone Incongruity Index (FKUI)
Tidsramme: Baseline (at study enrollment)
|
Assessment of the clinical applicability of the Functional Muscle-Bone Incongruity Index (FKUI), a composite index based on handgrip strength, total hip bone mineral density, and lumbar-hip bone mineral density discordance.
|
Baseline (at study enrollment)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2026
Primær færdiggørelse (Anslået)
1. maj 2027
Studieafslutning (Anslået)
1. maj 2027
Datoer for studieregistrering
Først indsendt
24. juni 2026
Først indsendt, der opfyldte QC-kriterier
24. juni 2026
Først opslået (Faktiske)
30. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Knoglesygdomme
- Muskuloskeletale sygdomme
- Sygdomme i nervesystemet
- Neuromuskulære manifestationer
- Patologiske Tilstande, Anatomiske
- Metaboliske sygdomme
- Muskelatrofi
- Atrofi
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Osteoporose
- Sarkopeni
- Knoglesygdomme, metaboliske
Andre undersøgelses-id-numre
- FKUI
- KSS-TRH-FKUI-2026 (Anden identifikator: Kanuni Sultan Suleyman Training and Research Hospital Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
No plan has been established to share individual participant data.
Participant confidentiality will be maintained in accordance with ethical and institutional requirements.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .