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Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Preoperative neuromuscular exercise
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring Preoperative, Exercise, Joint Replacement, Hip, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept. of Orthopedics Svendborg Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Knee Intervention

Knee Control

Hip Intervention

Hip Control

Arm Description

Patients undergoing Total Knee Replacement. Exercise 8-10 weeks preoperatively

Patients undergoing Total Knee Replacement. Receives standard instructions

Patient undergoing Total Hip Replacement. Exercise 8-10 weeks preoperatively

Patients undergoing Total Hip Replacement. Receives standard instructions

Outcomes

Primary Outcome Measures

Change in self reported physical function. Assessed with KOOS/HOOS questionnaire subscale ADL Function
Further assessments: baseline, preoperative, 6 weeks postoperative and 1-year follow up

Secondary Outcome Measures

Self reported pain. Assessed with KOOS and HOOS subscale on pain.
Self reported quality of life (Qol). Assessed with KOOS and HOOS sub scale quality of life
Self reported quality of life. Assessed with EQ5D questionnaire
Observed physical function. Assessed with performance measures: 20 meter walk, 5 chair stands timed and one leg knee bendings/30 sec
Muscle strength estimated as average muscle power for muscles of the hip and knee

Full Information

First Posted
October 28, 2009
Last Updated
February 6, 2012
Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01003756
Brief Title
Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Odense University Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Preoperative, Exercise, Joint Replacement, Hip, Knee

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Knee Intervention
Arm Type
Experimental
Arm Description
Patients undergoing Total Knee Replacement. Exercise 8-10 weeks preoperatively
Arm Title
Knee Control
Arm Type
No Intervention
Arm Description
Patients undergoing Total Knee Replacement. Receives standard instructions
Arm Title
Hip Intervention
Arm Type
Experimental
Arm Description
Patient undergoing Total Hip Replacement. Exercise 8-10 weeks preoperatively
Arm Title
Hip Control
Arm Type
No Intervention
Arm Description
Patients undergoing Total Hip Replacement. Receives standard instructions
Intervention Type
Other
Intervention Name(s)
Preoperative neuromuscular exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in self reported physical function. Assessed with KOOS/HOOS questionnaire subscale ADL Function
Description
Further assessments: baseline, preoperative, 6 weeks postoperative and 1-year follow up
Time Frame
3 month postoperative (primary endpoint)
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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.
Title
Muscle strength estimated as average muscle power for muscles of the hip and knee
Time Frame
baseline, 1 week preop. and 3 month postop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ewa Roos, Professor, PT, PhD
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Allan Villadsen, MD
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Orthopedics Svendborg Community Hospital
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28061841
Citation
Fernandes L, Roos EM, Overgaard S, Villadsen A, Sogaard R. Supervised neuromuscular exercise prior to hip and knee replacement: 12-month clinical effect and cost-utility analysis alongside a randomised controlled trial. BMC Musculoskelet Disord. 2017 Jan 6;18(1):5. doi: 10.1186/s12891-016-1369-0.
Results Reference
derived
PubMed Identifier
24931956
Citation
Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Immediate efficacy of neuromuscular exercise in patients with severe osteoarthritis of the hip or knee: a secondary analysis from a randomized controlled trial. J Rheumatol. 2014 Jul;41(7):1385-94. doi: 10.3899/jrheum.130642. Epub 2014 Jun 15.
Results Reference
derived
PubMed Identifier
23661494
Citation
Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Postoperative effects of neuromuscular exercise prior to hip or knee arthroplasty: a randomised controlled trial. Ann Rheum Dis. 2014 Jun;73(6):1130-7. doi: 10.1136/annrheumdis-2012-203135. Epub 2013 May 9.
Results Reference
derived

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Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement

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