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Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover

19. november 2014 opdateret af: University of Florida

Comparative Resistance Exercise Effect on Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover

The purpose of this study is to determine if a 4 month resistance exercise program can reduce knee osteoarthritis pain functional impairment and cartilage turnover.

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

  • Forenede Stater
    • Florida
      • Gainesville, Florida, Forenede Stater, 32607
        • UF&Shands Orthopaedics and Sports Medicine Institute

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

60 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Osteoarthritis (OA) of the knee for >6 months
  • moderate to severe pain immediately following a 50-foot walk
  • knee pain primarily due to tibiofemoral OA and not from patellofemoral OA
  • bilateral standing anterior-posterior radiograph demonstrating grade 2 or 3 OA of the target knee
  • willing and able to participate in regular exercise for four months
  • free from musculoskeletal limitations that would preclude resistance exercise participation
  • free of abnormal cardiovascular responses during the screening graded maximal walk test

Exclusion Criteria:

  • unable to walk
  • regular resistance exercise training (>3X week) within the past 6 months
  • specific low back pain or acute back injury
  • spinal stenosis that precludes walking one block due to neurogenic claudication
  • any major injury to either knee within the prior 12 months
  • any surgery to either knee within the last 12 months
  • lumbar radiculopathy
  • vascular claudication
  • significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in either knee
  • have had corticosteroid or viscosupplement injections within three months of study participation
  • have added new over the counter or prescription pain medication within two months of study participation

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: Wait-list Non-exercise Control (CON)
Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
Andet: normal activities and clinical care
Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines
Aktiv komparator: Concentric Focused RX (CRX)
Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Andet: Concentric Focused Resistance Exercise
Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Aktiv komparator: Eccentric Focused RX (ERX)
The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while "assistance" is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
Andet: Eccentric Focused Resistance Exercise
Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months

The WOMAC is a standard, multidimensional, self-administered functional-health status instrument for patients with lower limb OA. Subjects will complete the self-assessment at the time intervals indicated to document any change in their perception of their functional health status.

Scale for Total score: the higher score means the worst the function and pain Total WOMAC scores will have a range of 0 to 96 (best and worst scores possible).

0-20 Womac pain (0= best, 20=worst) 0-8 Womac stiffness (0= best, 8=worst) 0-68 Womac functional (0= best, 68=worst) 0-96 Womac Total (0= best, 96=worst)
Baseline, 4 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Six Minute Walk Test; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
Each participant will walk at a self-selected pace in the lab around a pre-measured loop for a period of six minutes. Subjects will complete the walk test at the time intervals indicated to document any change. 6 minute walk test is a baseline and 4 month post intervention measurement. It is used to measure distance covered while walking during 6 minutes.
Baseline, 4 Months
Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
Functional abilities related to moving body weight will be captured using two standard tests, the chair rise time and stair climb time. Subjects will complete the tests at the time intervals indicated to document any change in their functional abilities.
Baseline, 4 Months
Leg Press Test; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
Each participant will do a one repetition maximum. Participants will perform a leg press. The leg press is a weight training exercise in which the individual pushes a weight or resistance away from them using their legs.
Baseline, 4 Months
Leg Extensions Test; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
Each participant perform a one repetition maximum . Participants will perform a leg extension which is a resistance weight training exercise that targets the quadriceps muscle in the legs. The exercise is done using a machine called the Leg Extension Machine. This resistence is measured in pounds.
Baseline, 4 Months
Leg Curl Test; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
Each participant will perform a one repetition maximum. Participant will perform a leg curl which is an isolation exercise that targets the hamstring muscles. The exercise involves flexing the lower leg against resistance towards the buttocks. This resistence is measured in pounds.
Baseline, 4 Months
Chest Press; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
Each participant will perform a one repetition maximum. Participants will perform a chest press which is an upper body strength training exercise that consists of pressing a weight upwards from a supine position. This resistence is measured in pounds.
Baseline, 4 Months
Shoulder Press Test; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
Each participant will perform a one repetition maximum. Participants will perform the shoulder press which is a weight training exercise, typically performed while standing, in which a weight is pressed straight upwards from the shoulders until the arms are locked out overhead. This resistence is measured in pounds.
Baseline, 4 Months
Seated Row Test; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
Each participant will perform a one repetition maximum. Participants will do a seated row test which is pulling on a cable to lift weight from a seated row position. This resistence is measured in pounds.
Baseline, 4 Months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Florida

Efterforskere

  • Ledende efterforsker: Kevin R Vincent, M.D. Ph.D., University of Florida Department of Orthopaedics and Rehabilitaion

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. november 2010

Primær færdiggørelse (Faktiske)

1. juni 2013

Studieafslutning (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først indsendt

5. november 2010

Først indsendt, der opfyldte QC-kriterier

19. november 2010

Først opslået (Skøn)

22. november 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 614-2009

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