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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

May 12, 2009
May 21, 2014
June 2009
June 2012   (final data collection date for primary outcome measure)
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 ]
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). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00913575 on ClinicalTrials.gov Archive Site
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 ]
To study the effect of a pre-surgery neuromuscular PT compared to an attention control program on length of stay (LOS) in acute care after surgery, minutes of care by the nursing staff, and discharge potential measured by a risk score. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Knee Osteoarthritis
  • 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
  • Behavioral: knee OA School
    The education group will only receive 4 sessions of the Knee OA School.
    Other Name: knee school
  • Experimental: preoperative neuromuscular training
    preoperative neuromuscular training
    Intervention: Other: preoperative neuromuscular training
  • Placebo Comparator: education
    knee school
    Intervention: Behavioral: knee OA School
Huber EO, de Bie RA, Roos EM, Bischoff-Ferrari HA. Effect of pre-operative neuromuscular training on functional outcome after total knee replacement: a randomized-controlled trial. BMC Musculoskelet Disord. 2013 May 3;14:157. doi: 10.1186/1471-2474-14-157.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
June 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
60 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00913575
2009/012
Yes
Erika Huber, University of Zurich
University of Zurich
  • Kantonsspital Olten
  • Kantonsspital Aarau
  • Lund University
  • Maastricht University
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
University of Zurich
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP