Effect of Pre-surgery Neuromuscular Physiotherapy (PT) (Omega)

May 21, 2014 updated by: Erika Huber, University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital, Centre on Aging and Mobility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: preoperative neuromuscular training
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.
Other Names:
  • exercise
Placebo Comparator: education
knee school
Behavioral: knee OA School
The education group will only receive 4 sessions of the Knee OA School.
Other Names:
  • knee school

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lower limb function by the Chair stands (observed measure)
Time Frame: 6 wks pre-surgery, 1 wk pre-surgery 3 months post-surgery
6 wks pre-surgery, 1 wk pre-surgery 3 months post-surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 wks pre-surgery, 1 wk pre-surgery, 6 wks post-surgery, 3 months post-surgery, 12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Lund University
Kantonsspital Aarau
Maastricht University
Kantonsspital Olten

Investigators

  • Principal Investigator: Heike A Bischoff-Ferrari, MD, DrPH, UniversitaetsSpital Zuerich, Switzerland
  • Principal Investigator: Ewa M Roos, PT, Prof Dr, University of Southern Denmark, Denmark
  • Principal Investigator: Rob A de Bie, PT, Prof Dr, Maastricht University, Netherlands
  • Principal Investigator: Christoph A Schwaller, MD, Dr, Kantonsspital Olten
  • Principal Investigator: Marc Zumstein, MD, Dr, Kantonsspital Aarau, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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