Effect of Pre-surgery Neuromuscular Physiotherapy (PT)

NCT00913575 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2014-05-22

No results posted yet for this study

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. 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.

Conditions

Interventions

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.

BEHAVIORAL

knee OA School

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

Sponsors & Collaborators

  • Kantonsspital Olten

    collaborator OTHER
  • Kantonsspital Aarau

    collaborator OTHER
  • Lund University

    collaborator OTHER
  • Maastricht University

    collaborator OTHER
  • University of Zurich

    lead OTHER

Principal Investigators

  • Heike A Bischoff-Ferrari, MD, DrPH · UniversitaetsSpital Zuerich, Switzerland

  • Ewa M Roos, PT, Prof Dr · University of Southern Denmark, Denmark

  • Rob A de Bie, PT, Prof Dr · Maastricht University, Netherlands

  • Christoph A Schwaller, MD, Dr · Kantonsspital Olten

  • Marc Zumstein, MD, Dr · Kantonsspital Aarau, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-06-30
Completion
2013-06-30

Countries

  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00913575 on ClinicalTrials.gov