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Effect of Pre-surgery Neuromuscular Physiotherapy (PT)

Effect of Pre-surgery Neuromuscular Physiotherapy (PT) on Functional Outcome After Total Knee Replacement (TKR): A Single-blinded Randomized Controlled Trial.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00913575
Acronym
Omega
Enrollment
44
Registered
2009-06-04
Start date
2009-06-30
Completion date
2013-06-30
Last updated
2014-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

neuromuscular training, preoperative exercise, physiotherapy, total knee replacement, knee osteoarthritis

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: 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.

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.

Interventions

OTHERpreoperative 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.

BEHAVIORALknee OA School

The education group will only receive 4 sessions of the Knee OA School.

Sponsors

Kantonsspital Olten
CollaboratorOTHER
Kantonsspital Aarau
CollaboratorOTHER
Lund University
CollaboratorOTHER
Maastricht University
CollaboratorOTHER
University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Primary TKR for primary or secondary OA * Age 60 years or older * Community-dwelling * German language skills in word and writing

Exclusion criteria

* Age older than 85 years * Cognitive impairment * Revision surgery * Plan to leave Switzerland before or/and after surgery * History of inflammatory arthritis * Unable to walk for at least 3 meters with or without walking aid

Design outcomes

Primary

MeasureTime frame
Lower limb function by the Chair stands (observed measure)6 wks pre-surgery, 1 wk pre-surgery 3 months post-surgery

Secondary

MeasureTime frame
Lower limb function by the Knee Injury and Osteoarthritis Outcome Score (KOOS) (observed measure)6 wks pre-surgery, 1 wk pre-surgery, 6 wks post-surgery, 3 months post-surgery, 12 months post-surgery

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026