Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
19. november 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
90
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Florida
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Gainesville, Florida, Forente stater, 32607
- UF&Shands Orthopaedics and Sports Medicine Institute
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
60 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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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.
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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
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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.
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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.
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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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Six Minute Walk Test; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
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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.
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Baseline, 4 Months
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Chair Rise Time and Stair Climb Time; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
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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.
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Baseline, 4 Months
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Leg Press Test; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
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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.
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Baseline, 4 Months
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Leg Extensions Test; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
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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.
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Baseline, 4 Months
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Leg Curl Test; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
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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.
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Baseline, 4 Months
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Chest Press; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
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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.
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Baseline, 4 Months
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Shoulder Press Test; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
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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.
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Baseline, 4 Months
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Seated Row Test; Change From Baseline at 4 Months
Tidsramme: Baseline, 4 Months
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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.
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Baseline, 4 Months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Kevin R Vincent, M.D. Ph.D., University of Florida Department of Orthopaedics and Rehabilitaion
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2010
Primær fullføring (Faktiske)
1. juni 2013
Studiet fullført (Faktiske)
1. juni 2013
Datoer for studieregistrering
Først innsendt
5. november 2010
Først innsendt som oppfylte QC-kriteriene
19. november 2010
Først lagt ut (Anslag)
22. november 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
5. desember 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. november 2014
Sist bekreftet
1. november 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 614-2009
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