Effect of Pre-surgery Neuromuscular Physiotherapy (PT) (Omega)
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| First Received Date ICMJE | May 12, 2009 | ||||||||||||||||||||
| Last Updated Date | October 15, 2011 | ||||||||||||||||||||
| Start Date ICMJE | June 2009 | ||||||||||||||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Lower limb function by the Chair stands (observed measure) [ Time Frame: 6 wks pre-surgery, 1 wk pre-surgery 3 months post-surgery ] [ Designated as safety issue: No ] | ||||||||||||||||||||
| Original Primary Outcome Measures ICMJE |
To study the effect of a pre-surgery neuromuscular PT compared to an attention control program on lower extremity function measured by the Chair stands test (observed function) and the KOOS score (reported function). [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00913575 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Lower limb function by the Knee Injury and Osteoarthritis Outcome Score (KOOS) (observed measure) [ Time Frame: 6 wks pre-surgery, 1 wk pre-surgery, 6 wks post-surgery, 3 months post-surgery, 12 months post-surgery ] [ Designated as safety issue: No ] | ||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE |
To study the effect of a pre-surgery neuromuscular PT compared to an attention control program on length of stay (LOS) in acute care after surgery, minutes of care by the nursing staff, and discharge potential measured by a risk score. [ Time Frame: 14 days ] [ Designated as safety issue: No ] | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Effect of Pre-surgery Neuromuscular Physiotherapy (PT) | ||||||||||||||||||||
| Official Title ICMJE | Effect of Pre-surgery Neuromuscular Physiotherapy (PT) on Functional Outcome After Total Knee Replacement (TKR): A Single-blinded Randomized Controlled Trial. | ||||||||||||||||||||
| Brief Summary | Background: Osteoarthritis (OA) is a common degenerative condition of large weight-bearing joints, such as the hip and knee, as well as small hand joints. Current interventions in patients with OA are limited to symptomatic pain relief and later with total joint replacement (TJR). While TJR improves function and pain, it does not fully restore function in most individuals. A key factor of functional outcome is probably conditioning before and after TJR surgery. However, this has not been studied conclusively in patients undergoing TKR surgery. Objective:
Hypothesis: The investigators hypothesize that patients undergoing pre-surgery PT will be significantly quicker in performing the chair stands test and report a significant improvement in the KOOS at 3 months after surgery compared to controls. Methods: 80 patients from a waiting list for unilateral TKR will be randomized to neuromuscular PT or an attention control group intervention in a single-blinded randomized controlled trial. Assessments will be at baseline, at 3 months after surgery and at 12 months after surgery. Intervention: The neuromuscular PT group will receive a minimum of 8 and a maximum of 24 training sessions; all patients, including the control group, will receive 4 sessions of the Knee School. Significance: Given the demographic change with an increase in the older segment of the population there will be a rise in the absolute number of TKRs. It is therefore warranted to study pre-surgery neuromuscular PT to help patients get the most out of their joint replacement. |
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| Detailed Description | Due to the demographic change with a significant increase in the older segment of the population, recent estimates in the United States suggest that the rate of TKR surgery will rise exponentially over the next decade. A similar trend is expected in Switzerland with a marked increase in the absolute number of TKR surgery. Today, patients waiting for TKR surgery in Switzerland are neither routinely participating in an active training program to reduce pain and improve function nor in an educational program to increase coping skills before surgery. The intervention group will receive neuromuscular training as well as 4 sessions of the Knee OA School. Both will be offered in group sessions separate from the control group. a) The neuromuscular training will take place under the supervision of an experienced physiotherapist, 2 sessions a week of 60 minutes each. The training program, based on neuromuscular and biomechanical principles, according to the possibilities of the patient. The training sessions consists of three parts: warming up (ergometer cycling), a circuit program, and cooling down (walking, stretching, mobility). The circuit program comprises four exercise circles with the key elements of core stability, postural function, functional alignment, lower extremity muscle strength, and functional exercises. b) The Knee School is an educational program and takes place in three group sessions and one individual follow-up session. Patients receive information about: anatomy and physiology of the knee (first group session); proposed physical activity and pain self-management (second group session); and the rehabilitation phase after surgery (third group session). The control group will receive the Knee School sessions without the neuromuscular PT separate from the intervention group to avoid interaction between the groups. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Phase | Phase 3 | ||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Knee Osteoarthritis | ||||||||||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||||||||||||||
| Estimated Completion Date | June 2013 | ||||||||||||||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | 60 Years to 85 Years | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT00913575 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | 2009/012 | ||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||
| Responsible Party | Erika Huber, University of Zurich | ||||||||||||||||||||
| Study Sponsor ICMJE | University of Zurich | ||||||||||||||||||||
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| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||||||||||||||||||
| Verification Date | October 2011 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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