Resistance Exercise and Knee Osteoarthritis Pain, Functional Impairment and Cartilage Turnover
19 november 2014 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
90
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Florida
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Gainesville, Florida, Förenta staterna, 32607
- UF&Shands Orthopaedics and Sports Medicine Institute
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
60 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Score); Change From Baseline at 4 Months
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Six Minute Walk Test; Change From Baseline at 4 Months
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Kevin R Vincent, M.D. Ph.D., University of Florida Department of Orthopaedics and Rehabilitaion
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2010
Primärt slutförande (Faktisk)
1 juni 2013
Avslutad studie (Faktisk)
1 juni 2013
Studieregistreringsdatum
Först inskickad
5 november 2010
Först inskickad som uppfyllde QC-kriterierna
19 november 2010
Första postat (Uppskatta)
22 november 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 december 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 november 2014
Senast verifierad
1 november 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 614-2009
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