NCT00913575

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. 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. 2.Secondary endpoints will be muscle strength, walking time and mobility.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3 knee-osteoarthritis

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_3 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2009

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

3 years

First QC Date

May 12, 2009

Last Update Submit

May 21, 2014

Conditions

Knee Osteoarthritis

Keywords

neuromuscular trainingpreoperative exercisephysiotherapytotal knee replacementknee osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Lower limb function by the Chair stands (observed measure)

    6 wks pre-surgery, 1 wk pre-surgery 3 months post-surgery

Secondary Outcomes (1)

  • 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

Study Arms (2)

preoperative neuromuscular training

EXPERIMENTAL

preoperative neuromuscular training

Other: preoperative neuromuscular training

education

PLACEBO COMPARATOR

knee school

Behavioral: knee OA School

Interventions

preoperative neuromuscular trainingOTHER

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.

Also known as: exercise
preoperative neuromuscular training
knee OA SchoolBEHAVIORAL

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

Also known as: knee school
education

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Centre on Aging and Mobility

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 23641782DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ex. MHSA, PT

Study Record Dates

First Submitted

May 12, 2009

First Posted

June 4, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

CH(1)