Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement

Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003756
• Other study ID #: s-20090099
• Status: Completed
• Phase: N/A
• First received: October 28, 2009
• Last updated: February 6, 2012
• Start date: November 2009
• Est. completion date: August 2011

Study information

• Verified date: February 2012
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
Denmark	Dept. of Orthopedics Svendborg Community Hospital	Svendborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 month postoperative (primary endpoint)	No
Secondary	Self reported pain. Assessed with KOOS and HOOS subscale on pain.		baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up	No
Secondary	Self reported quality of life (Qol). Assessed with KOOS and HOOS sub scale quality of life		baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up	No
Secondary	Self reported quality of life. Assessed with EQ5D questionnaire		baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up	No
Secondary	Observed physical function. Assessed with performance measures: 20 meter walk, 5 chair stands timed and one leg knee bendings/30 sec		baseline, one week preop. and 3 month postop.	No
Secondary	Muscle strength estimated as average muscle power for muscles of the hip and knee		baseline, 1 week preop. and 3 month postop	No