- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07253714
EFFEKTEN AF PROPRIOCEPTIV ØVELSESTRÆNING PÅ CERVICAL PROPRIOCEPTION, KINESIOFOBI OG SMERTEKATASTROFERINGS-NIVEAUER HOS SARKOPENISKE GERIATRISKE PERSONER, DER BOR PÅ PLEJEHJEM
EFFEKTEN AF PROPRIOCEPTIV TRÆNING PÅ CERVICAL PROPRIOCEPTION, KINESIOFOBI OG SMERTEKATASTROFERINGS NIVEAU HOS SARKOPENISKE GERIATRISKE PERSONER I PLEJEHJEM
Denne undersøgelse undersøgte virkningerne af cervikal proprioceptiv træning på cervikal proprioception, kinesiofobi og smertekatastrofisering hos sarkopeniske plejehjemsbeboere.
I denne randomiserede kontrollerede undersøgelse blev 63 plejehjemsbeboere screenet for sarkopeni baseret på EWGSOP2-kriterierne, som inkluderer vurderinger af håndstyrke (Jamar-dynamometer), fysisk præstation (4-meter gangtest) og muskelmasse evalueret ved bioelektrisk impedansanalyse. Enogtredive beboere diagnosticeret med sarkopeni blev tilfældigt tildelt enten en kontrolgruppe (n = 17), som gennemførte 12 overvågede sessioner af konventionelle øvelser (holdnings-, cervikal bevægeligheds- og isometriske øvelser) over seks uger, eller en eksperimentel gruppe (n = 14), som modtog yderligere 12 sessioner af cervikale proprioceptive øvelser. Begge grupper blev evalueret før og efter interventionen. Cervikal ledpositionssans, kinesiofobi og smertekatastrofisering blev vurderet ved hjælp af Joint Position Error Test; Tampa Scale of Kinesiophobia; Pain Catastrophizing Scale.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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çankaya
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Ankara, çankaya, Tyrkiet (Türkiye), 06530
- Nevia Oran Nursing Home
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier;
- At være 65 år eller ældre,
- At være diagnosticeret med sarkopeni,
- At have mindst 91 point eller mere ifølge Barthels daglige livsaktivitetsindex (være let afhængig eller helt uafhængig),
- At have 24 point eller mere ifølge den mini-mentale vurdering, som betragtes som mentalt sund.
Eksklusionskriterier;
- At have en handicap (såsom lem, syn, høretab),
- At have en alvorlig neurologisk, ortopædisk eller reumatologisk lidelse, der kan påvirke proprioception,
- At have ukontrolleret hypertension/diabetes,
- At have smerter i rygraden og/eller ekstremiteterne,
- At have en psykiatrisk sygdomsdiagnose.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Eksperimentel gruppe
Cervikal proprioceptiv træning og klassisk træning blev anvendt.
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Deltagerne i kontrolgruppen modtog klassisk motionstræning i 6 uger.
Deltagerne i forsøgsgruppen modtog cervicale proprioception øvelser ud over klassisk træning i 6 uger.
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Aktiv komparator: Kontrolgruppe
Klassisk træning (cervikal rækkevidde øvelse + holdningsøvelse + isometriske øvelser) blev kun anvendt.
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Deltagerne i kontrolgruppen modtog klassisk motionstræning i 6 uger.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Vurdering af cervikal proprioception
Tidsramme: 10 måneder
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Cervikal proprioception blev vurderet ved hjælp af ledpositionsfejltesten.
Mens de sad, vendte deltageren mod en tavle placeret 90 cm væk i hovedhøjde, bestående af koncentriske cirkler (40 cm diameter, 1 cm trin), og bar en hue med en monteret laserpointer. Deltageren justerede først laseren med midtpunktet for at etablere neutralpositionen, derefter - med åbne øjne - blev vejledt gennem fleksion, ekstension, højre/venstre rotation og højre/venstre lateralfleksion, og vendte tilbage til neutral efter hver bevægelse.
De samme seks bevægelser blev derefter aktivt udført med lukkede øjne.
Seks gentagelser blev gennemført for hver retning, og punktet, hvor laseren stoppede, blev markeret på tavlen efter hver prøve.
Gennemsnittet af disse punkter blev beregnet, og vinkelafvigelsen fra målet blev bestemt ved hjælp af arctan-metoden baseret på den faste afstand til tavlen.
En afvigelse på mere end 4 grader blev anset for at indikere nedsat proprioception.
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10 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Vurdering af kinesiofobi
Tidsramme: 10 måneder
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Kinesiofobi blev vurderet ved hjælp af Kinesiofobi Årsager Skalaen (KCS).
Udviklet af Kocjan og Knapik (2014), identificerer skalaen de biologiske og psykologiske kilder til frygt for bevægelse og bidrager til forståelsen af de underliggende årsager til reduceret motorisk aktivitet. Den omfatter to domæner: biologisk og psykologisk. Det biologiske domæne inkluderer morfologiske faktorer, bevægelseskrav, energiresourcer, biologiske drifter, negative erfaringer, motorisk kompetence og overbevisninger relateret til kropspleje, mens det psykologiske domæne vurderer faktorer såsom selvtillid, selveffektivitet og social interaktion, der bidrager til undgåelsesadfærd. Det tyrkiske validitets- og pålidelighedsstudie blev udført af Çayır et al. (2020). Skalaen består af 20 emner vurderet på en 5-punkts Likert-skala (1 = meget uenig, 5 = meget enig). Højere score indikerer større frygt for bevægelse. |
10 måneder
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Vurdering af smertekatastrofisering
Tidsramme: 10 måneder
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Smertekatastrofisering blev vurderet ved hjælp af Smertekatastrofiseringsskalaen (PCS), et 13-punkts mål, der evaluerer maladaptive tanker og følelser relateret til smerte.
Skalaen indeholder tre underdimensioner: hjælpeløshed, forstørrelse og grubleri.
Hvert punkt scores på en 0-4 skala, og underskalascore opnås ved at summere de tilsvarende punkter; den samlede PCS-score beregnes som summen af alle punkter.
Den tyrkiske validitets- og pålidelighedsundersøgelse blev udført af Uğurlu et al. (2017).
Samlede scorer spænder fra 0 til 52, hvor højere scorer indikerer større smertekatastrofisering. Scorer over 30 afspejler klinisk signifikante niveauer af katastrofisering.
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10 måneder
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
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