- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01345825
Early Progressive Strength Training to Patients With Unicompartmental Knee Replacement
A Randomized Controlled Trial: The Effectiveness of 8-weeks Progressive Strength Training to Patients With Unicompartmental Knee Replacement, Initiated Within the First Postoperative Week
The purpose and Study hypotheses:
The purpose of the study is to investigate the effect of progressive resistance training in the early postoperative phase on patients who has had unicompartmental knee replacement. The hypotheses are that this group compared to a control group will achieve greater muscle strength and functional ability in terms of gait and working capacity.
Study design:
The subjects will be randomized into two groups; intervention and control. Intervention group: strength training two times a week supervised by a physiotherapist.
Control group: Training at home, following extradited guidelines.
Endpoint:
Primary endpoint is two months postoperative. The following test will be used: muscle power test (by a Power Rig), instrumented gait analysis using a combined accelerometer and gyro-sensor in; 6 min. walk test, stair climbing test, 20 meter walking test and block step test.
Furthermore, the questionnaire KOOS will be used for monitoring every 2 weeks.
Sample size:
The power calculation is based on an expected improvement in muscle power by 25%. The risk of a type 1 error is set to 5 %, and the power is set to 80%. The calculations showed that 24 patients are needed in both groups, but 30 patient will be included in both groups to account for dropouts.
Perspectives:
This study is, to our knowledge, the first study to investigate the effect of strength training after unicompartmental knee replacement. Moreover it has , to our knowledge not been. At the moment no guidelines for rehabilitation exist, and research showed that this group of patients has a decreased function in their daily living compared with the background population. If, as expected, cases have an overall increased function compared to controls, this study can provide a basis for future rehabilitation.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Aarhus, Danmark, 8000
- Aarhus University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- medial osteoarthrosis in knee assigned to unicompartmental knee replacement
- 18+ years.
Exclusion Criteria:
- rheumatoid arthritis
- neuro muscular conditions
- alcohol or drug abuse
- cognitive problems
- patients not fluid in the Danish language
- walking disability caused by other than in condition in question
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: modstandstræning
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Week 1: 2 sets x 12 repetitions at 12 RM Week 2: 3 sets of 12 repetitions with 12 RM Week 3: 3 sets of 10 repetitions with 10 RM Week 4-5: 3 sets of 10 repetitions with 10 RM Week 6: 3 sets of 8 repetitions with 8 RM Week 7: 4 sets of 8 repetitions with 8 RM Week 8: 4 sets of 8 repetitions with 8 RM
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Muscle power test (by a power rig)
Tidsramme: prior to operation (baseline), 9 weeks post operativ and 1 year post operative
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prior to operation (baseline), 9 weeks post operativ and 1 year post operative
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Gait quality
Tidsramme: prior to operation (baseline), 9 weeks post operativ and 1 year post operative
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Instrumentet gait analysis using a combined gyro-sensor and accelerometer - inertia measurement unit(IMU).
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prior to operation (baseline), 9 weeks post operativ and 1 year post operative
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Kjeld Søballe, Orthopaedic Surgery Research Unit, Aarhus
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- M-20100185
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