A Phase 3 interventional study of preoperative neuromuscular training and knee OA School in Knee Osteoarthritis, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-05-22.
Sponsored by University of Zurich · Phase 3, Interventional, and Treatment
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 44 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
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Exclusion criteria:
preoperative neuromuscular training
Other: preoperative neuromuscular training
knee school
Behavioral: knee OA School
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.
Also known as: exercise
The education group will only receive 4 sessions of the Knee OA School.
Also known as: knee school
Lower limb function by the Chair stands (observed measure)
Time frame: 6 wks pre-surgery, 1 wk pre-surgery 3 months post-surgery
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
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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University of Zurich