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Strength Training After Hip Fracture Surgery

2. juni 2015 opdateret af: Morten Tange Kristensen, Hvidovre University Hospital

Effect of Rehabilitation With Versus Without Progressive Strength Training Implemented in the Acute Ward After Hip Fracture Surgery: A Randomized Controlled Trial

The purpose of this study is to examine the effect of progressive strength training of the fractured limb in patients with hip fracture, during admittance in an acute orthopedic ward. The primary study hypothesis is that the training will reduce the strength deficit in the fractured limb in comparison with the non-fractured limb. Secondary, that patients following the intervention will present larger improvements in physical function compared to controls.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
    • Copenhagen
      • Hvidovre, Copenhagen, Danmark, 2650
        • Department of Orthopedic Surgery hvidovre hospital

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

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Primary hip fracture surgery
  • 65 years or older
  • Speak and understand the Danish language
  • Able to give informed consent
  • Home-dwelling with and independent prefracture indoor walking ability equal to New Mobility Score >=2

Exclusion Criteria:

  • Multiple fractures
  • Weightbearing restrictions
  • Patient unwilling to participate in appropriate rehabilitation
  • Not able to cooperate to tests
  • Terminal illness
  • Patients who want an observer present at the information interview, but where such one is not available.
  • Patients with a cervical hip fracture treated with Total Hip Arthroplasty or hip pins, due to expected short length of hospital stay.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Rehabilitation without strength training
Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually.
Andet: Rehabilitation without strength training
Basic mobility and exercise therapy without strength training following a guideline with 12 specific exercises, progressed individually.
Eksperimentel: Rehabilitation with strength training
Basic mobility and exercise therapy following a guideline with 12 specific exercises, progressed individually, and supplemented with progressive knee-extension strength training (10RM) of fractured limb every day during admission.
Andet: Rehabilitation with strength training
Basic mobility and exercise therapy following a guideline with 12 specific exercises, progressed individually, and supplemented with progressive knee-extension strength training (10RM) of the fractured limb using ankle weight cuffs, daily during hospital stay.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Knee-extension strength in the fractured limb in comparison with the non-fractured limb.
Tidsramme: At inclusion, at postoperative day 10 and/or at discharge.
Maximal isometric knee-extension strength in the fractured limb in percentage of non-fractured limb. Isometric knee-extension strength will be measured using an externally fixated handheld dynamometer (Power Track II Commander; JTech Medical, Utah). A stap will be attached to the bed/chair and the patient's ankle (perpendicular to the lower leg), ensuring 90 degrees of knee flexion and an isometric contraction. The transducer will be placed under the strap at ankle level, just proximal to the malleolus, and the participant will be asked to extend the leg as forcefully as possible. Knee-extension strength will be expressed as the maximal voluntary torque per kilo body mass ([NIm]/kg), using the distance between the lateral femoral epicondyle and the center of the transducer and the body mass of each patient. The best of 4 trials for each limb will be used in analyses. The primary analysis will follow the intention-to-treat principle (last observation carried forward).
At inclusion, at postoperative day 10 and/or at discharge.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Timed up and go test
Tidsramme: From inclusion to postoperative day 10 and/or discharge
Timed Up and Go test is assessed as early as possible during in-hospital stay and at discharge.
From inclusion to postoperative day 10 and/or discharge

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
10 meter fast speed, Cumulated Ambulation Score.
Tidsramme: At discharge and during in-hospital stay.
Cumulated Ambulation Score is recorded every day from inclusion to discharge. 10 meter fast speed is assessed at postoperative day 10 and/or discharge.
At discharge and during in-hospital stay.
Short Falls Efficacy Scale-International (Short FES-I)
Tidsramme: At discharge
A questionnaire evaluation of the patient's subjective concern at the moment for falling related to 7 different physical functions. Score 7-28, with maximum score expressing very high concern of falling in all 7 physical functions.
At discharge
Verbal Ranking Scale (VRS)
Tidsramme: During in-hospital stay.
Evaluation of experienced hip-fracture related pain at rest and during strength training and testing.
During in-hospital stay.
24-hour activity
Tidsramme: From inclusion to discharge
24-hour sit/lie and stand/walk activity measured by a ActivPAL3 activity monitor (PAL Technologies Ltd, Scotland) attached to the patient's non-fractured thigh.
From inclusion to discharge

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hvidovre University Hospital

Efterforskere

  • Ledende efterforsker: Lise Kronborg, MSc, PMR-C, Copenhagen University at Hvidovre Hospital.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. oktober 2013

Primær færdiggørelse (Faktiske)

1. juni 2015

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

19. februar 2009

Først indsendt, der opfyldte QC-kriterier

19. februar 2009

Først opslået (Skøn)

20. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. juni 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2015

Sidst verificeret

1. juni 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H-A-2007-0127 + 37036

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 .

Kliniske forsøg med Hoftebrud

Kliniske forsøg med Rehabilitation without strength training

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