Effect of Pre-surgery Neuromuscular Physiotherapy (PT)
NCT00913575 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44
Last updated 2014-05-22
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:
1. Primary endpoint: 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).
2. Secondary endpoints will be muscle strength, walking time and mobility.
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.
Conditions
Interventions
- OTHER
-
preoperative neuromuscular training
The neuromuscular training group will receive a minimum of 8 and a maximum of 24 training sessions; as well as 4 sessions of the Knee OA School.
- BEHAVIORAL
-
knee OA School
The education group will only receive 4 sessions of the Knee OA School.
Sponsors & Collaborators
-
Kantonsspital Olten
collaborator OTHER -
Kantonsspital Aarau
collaborator OTHER -
Lund University
collaborator OTHER -
Maastricht University
collaborator OTHER -
University of Zurich
lead OTHER
Principal Investigators
-
Heike A Bischoff-Ferrari, MD, DrPH · UniversitaetsSpital Zuerich, Switzerland
-
Ewa M Roos, PT, Prof Dr · University of Southern Denmark, Denmark
-
Rob A de Bie, PT, Prof Dr · Maastricht University, Netherlands
-
Christoph A Schwaller, MD, Dr · Kantonsspital Olten
-
Marc Zumstein, MD, Dr · Kantonsspital Aarau, Switzerland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2012-06-30
- Completion
- 2013-06-30
Countries
- Switzerland
Study Locations
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