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Pre-operatieve training in oudere orthopedische patienten - een experimenteel en klinisch onderzoek.


- candidate number5607
- NTR NumberNTR1760
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-apr-2009
- Secondary IDs27942  ABR
- Public TitlePre-operatieve training in oudere orthopedische patienten - een experimenteel en klinisch onderzoek.
- Scientific TitlePre-operative training in elderly orthopaedic patients - an experimental and clinical trial.
- ACRONYMP.R.O.T.E.C.T
- hypothesisPre-operative training improves physical recovery after surgery for lumbar spinal stenosis.
- Healt Condition(s) or Problem(s) studiedOrthopaedic patients, Patients who undergo major surgery, Spinal stenosis
- Inclusion criteria1. Diagnosed degenerative lumbar spinal stenosis (at one or multiple levels);
2. Patients are suffering form back and leg pain;
3. Patients are on the waiting list for surgery (laminectomy, sometimes combined with spinal fusion);
4. Patients are aged between 55 and 75 years old;
5. Patients are able to walk at least 10 metres at one go;
6. Patients understand the study protocol and questionnaires used.
- Exclusion criteria1. Hip or knee osteoarthritis;
2. Previous spinal surgery;
3. Any previous surgery in the past 24 months;
4. Complaints that interfere with motoric functioning (e.g. CVA Parkinsons disease, an unstable cardiovascular status).
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate
- planned closingdate
- Target number of participants74
- InterventionsPre-operative training.
- Primary outcome1. Increase of 0.10 m/s of preferred or maximal walking velocity (10-meter walk test) of the intervention group compared to the control group, time point 12 months post surgery;
2. Higher increase in endurance time of a fatiguing sitting test in the intervention group compared to the control group, time point 12 months post surgery.
- Secondary outcomeA 5% higher increase in health related quality of life (SF-36) of the intervention group compared to the control group, time point 12 months post surgery.
- Timepoints1. Two months pre-surgery;
2. One week pre-surgery;
3. 6 weeks post-surgery;
4. 6 months post-surgery;
5. 12 months post-surgery.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf.dr. J.H. en A. Dieen, van en Haan, de
- CONTACT for SCIENTIFIC QUERIESProf.dr. J.H. en A. Dieen, van en Haan, de
- Sponsor/Initiator MOVE
- Funding
(Source(s) of Monetary or Material Support)
MOVE Research Institute
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD15-apr-2009 - 23-sep-2009


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