- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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-
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Aarhus, Danmark, 8000
- Aarhus University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: motstandstrening
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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
|
Hva måler studien?
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 |
Tiltaksbeskrivelse |
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).
|
prior to operation (baseline), 9 weeks post operativ and 1 year post operative
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Kjeld Søballe, Orthopaedic Surgery Research Unit, Aarhus
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- M-20100185
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