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

This study has been completed.
Sponsor:
Collaborators:
Kantonsspital Olten
Kantonsspital Aarau
Lund University
Maastricht University
Information provided by (Responsible Party):
Erika Huber, University of Zurich
ClinicalTrials.gov Identifier:
NCT00913575
First received: May 12, 2009
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Other: preoperative neuromuscular training
Behavioral: knee OA School
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Pre-surgery Neuromuscular Physiotherapy (PT) on Functional Outcome After Total Knee Replacement (TKR): A Single-blinded Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 44
Study Start Date: June 2009
Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: preoperative neuromuscular training
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 Name: exercise
Placebo Comparator: education
knee school
Behavioral: knee OA School
The education group will only receive 4 sessions of the Knee OA School.
Other Name: knee school

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.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913575

Locations
Switzerland
University Hospital, Centre on Aging and Mobility
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Kantonsspital Olten
Kantonsspital Aarau
Lund University
Maastricht University
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
  More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erika Huber, ex. MHSA, PT, University of Zurich
ClinicalTrials.gov Identifier: NCT00913575     History of Changes
Other Study ID Numbers: 2009/012
Study First Received: May 12, 2009
Last Updated: May 21, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Zurich:
neuromuscular training
preoperative exercise
physiotherapy
total knee replacement
knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014