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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
preoperative neuromuscular training
knee OA School
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring neuromuscular training, preoperative exercise, physiotherapy, total knee replacement, knee osteoarthritis

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Centre on Aging and Mobility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

preoperative neuromuscular training

education

Arm Description

preoperative neuromuscular training

knee school

Outcomes

Primary Outcome Measures

Lower limb function by the Chair stands (observed measure)

Secondary Outcome Measures

Lower limb function by the Knee Injury and Osteoarthritis Outcome Score (KOOS) (observed measure)

Full Information

First Posted
May 12, 2009
Last Updated
May 21, 2014
Sponsor
University of Zurich
Collaborators
Kantonsspital Olten, Kantonsspital Aarau, Lund University, Maastricht University
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1. Study Identification

Unique Protocol Identification Number
NCT00913575
Brief Title
Effect of Pre-surgery Neuromuscular Physiotherapy (PT)
Acronym
Omega
Official Title
Effect of Pre-surgery Neuromuscular Physiotherapy (PT) on Functional Outcome After Total Knee Replacement (TKR): A Single-blinded Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich
Collaborators
Kantonsspital Olten, Kantonsspital Aarau, Lund University, Maastricht University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
neuromuscular training, preoperative exercise, physiotherapy, total knee replacement, knee osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
preoperative neuromuscular training
Arm Type
Experimental
Arm Description
preoperative neuromuscular training
Arm Title
education
Arm Type
Placebo Comparator
Arm Description
knee school
Intervention Type
Other
Intervention Name(s)
preoperative neuromuscular training
Other Intervention Name(s)
exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
knee OA School
Other Intervention Name(s)
knee school
Intervention Description
The education group will only receive 4 sessions of the Knee OA School.
Primary Outcome Measure Information:
Title
Lower limb function by the Chair stands (observed measure)
Time Frame
6 wks pre-surgery, 1 wk pre-surgery 3 months post-surgery
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heike A Bischoff-Ferrari, MD, DrPH
Organizational Affiliation
UniversitaetsSpital Zuerich, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ewa M Roos, PT, Prof Dr
Organizational Affiliation
University of Southern Denmark, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rob A de Bie, PT, Prof Dr
Organizational Affiliation
Maastricht University, Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christoph A Schwaller, MD, Dr
Organizational Affiliation
Kantonsspital Olten
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Zumstein, MD, Dr
Organizational Affiliation
Kantonsspital Aarau, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Centre on Aging and Mobility
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23641782
Citation
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.
Results Reference
derived

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Effect of Pre-surgery Neuromuscular Physiotherapy (PT)

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