Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement

February 6, 2012 updated by: Allan Villadsen, University of Southern Denmark

This study is conducted in the Community Hospital in Svendborg (OUH Svendborg Sygehus) in collaboration with University of Southern Denmark and Odense University Hospital.

The overall purpose of this study is to evaluate the effects of preoperatively delivered neuromuscular exercise on self perceived physical function, pain and Quality of Life in patients undergoing total hip or knee replacement. Secondary area of interest is physical performance, muscle function, and level of physical activity.

The project will be conducted in two phases:

  • A pilot project focusing on the logistics of the upcoming randomized controlled trial (RCT) and determination of test-retest reliability of specific muscle strength variables for the patients of interest
  • A randomized and controlled trial where the intervention is preoperative neuromuscular exercise and the controls receive standard instructions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Svendborg, Denmark, 5700
        • Dept. of Orthopedics Svendborg Community Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for elective primary, unilateral total hip or knee replacement in Svendborg Community Hospital, Odense University Hospital, Denmark.
  • Patients with osteoarthritis
  • Age over 18

Exclusion Criteria:

  • Not being able to read and understand Danish.
  • Patients with co-morbidity diseases where a moderate level of physical exercise is contraindicated, e.g. severe heart disease and neurological deficits.
  • Patients unable to attend intervention.
  • Rheumatoid arthritis (RA). A history of or ongoing use of medication for RA or other inflammatory arthritis such as gold, methotrexate, plaquenil etc.
  • Lack of wish to participate or unwillingness to sign an informed consent.
  • Specific for hip patients: a history of severe sequelae due to congenital hip-dysplasia requiring specialized postoperative training. A history of femoral neck and trochanteric fracture.
  • Patients planned to have bilateral joint replacement within same procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Knee Intervention
Patients undergoing Total Knee Replacement. Exercise 8-10 weeks preoperatively
Other: Preoperative neuromuscular exercise
A neuromuscular exercise programme delivered 8-10 weeks preoperatively. The programme is developed in Lund, Sweden. A journal of this study is under peer-review
No Intervention: Knee Control
Patients undergoing Total Knee Replacement. Receives standard instructions
Experimental: Hip Intervention
Patient undergoing Total Hip Replacement. Exercise 8-10 weeks preoperatively
Other: Preoperative neuromuscular exercise
A neuromuscular exercise programme delivered 8-10 weeks preoperatively. The programme is developed in Lund, Sweden. A journal of this study is under peer-review
No Intervention: Hip Control
Patients undergoing Total Hip Replacement. Receives standard instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self reported physical function. Assessed with KOOS/HOOS questionnaire subscale ADL Function
Time Frame: 3 month postoperative (primary endpoint)
Further assessments: baseline, preoperative, 6 weeks postoperative and 1-year follow up
3 month postoperative (primary endpoint)

Secondary Outcome Measures

Outcome Measure
Time Frame
Self reported pain. Assessed with KOOS and HOOS subscale on pain.
Time Frame: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
Self reported quality of life (Qol). Assessed with KOOS and HOOS sub scale quality of life
Time Frame: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
Self reported quality of life. Assessed with EQ5D questionnaire
Time Frame: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
Observed physical function. Assessed with performance measures: 20 meter walk, 5 chair stands timed and one leg knee bendings/30 sec
Time Frame: baseline, one week preop. and 3 month postop.
baseline, one week preop. and 3 month postop.
Muscle strength estimated as average muscle power for muscles of the hip and knee
Time Frame: baseline, 1 week preop. and 3 month postop
baseline, 1 week preop. and 3 month postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Odense University Hospital

Investigators

  • Study Chair: Ewa Roos, Professor, PT, PhD, University of Southern Denmark
  • Principal Investigator: Allan Villadsen, MD, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

October 28, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (Estimate)

October 29, 2009

Study Record Updates

Last Update Posted (Estimate)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 6, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s-20090099

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on Preoperative neuromuscular exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe