- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04503304
Effekt af hofteabduktorer versus knæekstensorforstærkning ved knæartrose
Effekt af hofteabduktorer versus knæforlængerforstærkning på smerte, funktion og isometrisk styrke i quadriceps ved knæartrose
Denne undersøgelse vil forsøge at besvare følgende spørgsmål:
Ville styrkelse af hofteabduktorer være lig med eller mere effektiv end knæekstensorer, der styrker til forbedring af smerte, funktion og knæekstensors isometrisk styrke hos patienter med knæartrose
Studieoversigt
Detaljeret beskrivelse
Der rekrutteres i alt 70 patienter med knæartrose. Alle patienter, der skal deltage i undersøgelsen, vil blive henvist af ortopæder. Patienter med knæartrose vil blive inkluderet i aldersgrupper fra 50-70. De vil blive randomiseret i 2 grupper; hofteabducerende styrkende (HAS) gruppe a vil modtage hofteabducerende styrkende øvelser, og knæforstærkende (KES) gruppe vil modtage quadriceps styrkende øvelse.
Alle patienter, der opfylder undersøgelseskriterierne, vil få et fuldstændigt kendskab til undersøgelsens mål og procedurer.
Inklusionskriterier:
- Patienter med knæ slidgigt grad II-III Kellgren-Lawrence scores
- Deres alder er 50-70 [Wang et al.,2019].
- Body mass index (BMI) 25-30.
Eksklusionskriterier:
- Patienter, der fik kirurgisk indgreb i knæ og/eller hofte.
- Brud i underekstremiteterne.
- Malignitet
- Eventuelle tilknyttede ledbåndsskader i knæ eller ankel.
- Rygmarvsskade.
- Hormonel ubalance eller på hormonbehandling
- Knæinjektion inden for de sidste 6 måneder forud for undersøgelsen. Resultatparametre, herunder Quadriceps Muscle Strength, den arabiske version af Western Ontario og McMaster Universities Arthritis Index spørgeskema totalscore og 3 subskalaer og Timed Up and Go testscore
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Cairo, Egypten
- Faculty of Physical Therapy
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- Patienter med knæ OA grad II-III Kellgren-Lawrence scores
- Deres alder er 50-70 [Wang et al.,2019].
- Body mass index (BMI) 25-30.
Ekskluderingskriterier:
- Patienter, der fik kirurgisk indgreb i knæ og/eller hofte.
- Brud i underekstremiteterne.
- Malignitet
- Eventuelle tilknyttede ledbåndsskader i knæ eller ankel.
- Rygmarvsskade.
- Hormonel ubalance eller på hormonbehandling
- Knæinjektion inden for de sidste 6 måneder forud for undersøgelsen.
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: HAR gruppe
hoftebortførere styrkende gruppe
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allerede inkluderet i arm/gruppebeskrivelser.
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Aktiv komparator: KES gruppe
knæekstensorer styrkende gruppe
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allerede inkluderet i arm/gruppebeskrivelser.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Quadriceps muskelstyrke vurdering
Tidsramme: 6 uger
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Quadriceps muskelstyrkevurdering ved hjælp af håndholdt dynamometer
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6 uger
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funktionsnedsættelse i underekstremiteterne
Tidsramme: 6 uger
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Måling af funktionsnedsættelse i underekstremiteterne ved hjælp af den arabiske version af reduceret WOMAC (ArWOMAC) indeks
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6 uger
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Knæ funktion
Tidsramme: 6 uger
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Målefunktion ved hjælp af Timed Up & Go Test (TUG):
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6 uger
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
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- Glass NA, Torner JC, Frey Law LA, Wang K, Yang T, Nevitt MC, Felson DT, Lewis CE, Segal NA. The relationship between quadriceps muscle weakness and worsening of knee pain in the MOST cohort: a 5-year longitudinal study. Osteoarthritis Cartilage. 2013 Sep;21(9):1154-9. doi: 10.1016/j.joca.2013.05.016.
- Hinman RS, Hunt MA, Creaby MW, Wrigley TV, McManus FJ, Bennell KL. Hip muscle weakness in individuals with medial knee osteoarthritis. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1190-3. doi: 10.1002/acr.20199.
- Hott A, Liavaag S, Juel NG, Brox JI. Study protocol: a randomised controlled trial comparing the long term effects of isolated hip strengthening, quadriceps-based training and free physical activity for patellofemoral pain syndrome (anterior knee pain). BMC Musculoskelet Disord. 2015 Feb 25;16:40. doi: 10.1186/s12891-015-0493-6.
- Hu B, Skou ST, Wise BL, Williams GN, Nevitt MC, Segal NA. Lower Quadriceps Rate of Force Development Is Associated With Worsening Physical Function in Adults With or at Risk for Knee Osteoarthritis: 36-Month Follow-Up Data From the Osteoarthritis Initiative. Arch Phys Med Rehabil. 2018 Jul;99(7):1352-1359. doi: 10.1016/j.apmr.2017.12.027. Epub 2018 Jan 31.
- Hurd WJ, Morrey BF, Kaufman KR. The effects of anthropometric scaling parameters on normalized muscle strength in uninjured baseball pitchers. J Sport Rehabil. 2011 Aug;20(3):311-20. doi: 10.1123/jsr.20.3.311.
- Ismail MM, Gamaleldein MH, Hassa KA. Closed kinetic chain exercises with or without additional hip strengthening exercises in management of patellofemoral pain syndrome: a randomized controlled trial. Eur J Phys Rehabil Med. 2013 Oct;49(5):687-98. Epub 2013 Jul 2.
- Kemnitz J, Wirth W, Eckstein F, Ruhdorfer A, Culvenor AG. Longitudinal change in thigh muscle strength prior to and concurrent with symptomatic and radiographic knee osteoarthritis progression: data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2017 Oct;25(10):1633-1640. doi: 10.1016/j.joca.2017.07.003. Epub 2017 Jul 8.
- Khayambashi K, Mohammadkhani Z, Ghaznavi K, Lyle MA, Powers CM. The effects of isolated hip abductor and external rotator muscle strengthening on pain, health status, and hip strength in females with patellofemoral pain: a randomized controlled trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):22-9. doi: 10.2519/jospt.2012.3704. Epub 2011 Oct 25.
- Liao CD, Huang YC, Lin LF, Huang SW, Liou TH. Body mass index and functional mobility outcome following early rehabilitation after a total knee replacement: a retrospective study in Taiwan. Arthritis Care Res (Hoboken). 2015 May;67(6):799-808. doi: 10.1002/acr.22474.
- Martin HJ, Yule V, Syddall HE, Dennison EM, Cooper C, Aihie Sayer A. Is hand-held dynamometry useful for the measurement of quadriceps strength in older people? A comparison with the gold standard Bodex dynamometry. Gerontology. 2006;52(3):154-9. doi: 10.1159/000091824.
- McNair PJ, Colvin M, Reid D. Predicting maximal strength of quadriceps from submaximal performance in individuals with knee joint osteoarthritis. Arthritis Care Res (Hoboken). 2011 Feb;63(2):216-22. doi: 10.1002/acr.20368.
- Messier SP, Mihalko SL, Beavers DP, Nicklas BJ, DeVita P, Carr JJ, Hunter DJ, Williamson JD, Bennell KL, Guermazi A, Lyles M, Loeser RF. Strength Training for Arthritis Trial (START): design and rationale. BMC Musculoskelet Disord. 2013 Jul 15;14:208. doi: 10.1186/1471-2474-14-208.
- Palmer K, Hebron C, Williams JM. A randomised trial into the effect of an isolated hip abductor strengthening programme and a functional motor control programme on knee kinematics and hip muscle strength. BMC Musculoskelet Disord. 2015 May 3;16:105. doi: 10.1186/s12891-015-0563-9.
- Rikli RE, Jones CJ. Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years. Gerontologist. 2013 Apr;53(2):255-67. doi: 10.1093/geront/gns071. Epub 2012 May 20.
- Ringdahl E, Pandit S. Treatment of knee osteoarthritis. Am Fam Physician. 2011 Jun 1;83(11):1287-92.
- Ruhdorfer A, Dannhauer T, Wirth W, Hitzl W, Kwoh CK, Guermazi A, Hunter DJ, Benichou O, Eckstein F; Osteoarthritis Initiative Investigators. Thigh muscle cross-sectional areas and strength in advanced versus early painful osteoarthritis: an exploratory between-knee, within-person comparison in osteoarthritis initiative participants. Arthritis Care Res (Hoboken). 2013 Jul;65(7):1034-42. doi: 10.1002/acr.21965.
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- Ruhdorfer A, Wirth W, Eckstein F. Longitudinal Change in Thigh Muscle Strength Prior to and Concurrent With Minimum Clinically Important Worsening or Improvement in Knee Function: Data From the Osteoarthritis Initiative. Arthritis Rheumatol. 2016 Apr;68(4):826-36. doi: 10.1002/art.39484.
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- Segal NA, Glass NA, Torner J, Yang M, Felson DT, Sharma L, Nevitt M, Lewis CE. Quadriceps weakness predicts risk for knee joint space narrowing in women in the MOST cohort. Osteoarthritis Cartilage. 2010 Jun;18(6):769-75. doi: 10.1016/j.joca.2010.02.002. Epub 2010 Feb 11.
- Segal NA, Findlay C, Wang K, Torner JC, Nevitt MC. The longitudinal relationship between thigh muscle mass and the development of knee osteoarthritis. Osteoarthritis Cartilage. 2012 Dec;20(12):1534-40. doi: 10.1016/j.joca.2012.08.019. Epub 2012 Sep 3.
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Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Hip Abductors strength in KOA
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Understøttende informationstype
- Studieprotokol
- Statistisk analyseplan (SAP)
- Formular til informeret samtykke (ICF)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .
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Fundació EurecatHISPANAGAR SARekrutteringBetændelse | Bruskskade | Ledskade | OsteoarthritisSpanien