Clinical trial NCT01003756: Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Preoperative
Exercise
Joint Replacement
Hip
Knee
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2009-10-29
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change in self reported physical function. Assessed with KOOS/HOOS questionnaire subscale ADL Function
timeFrame: 3 month postoperative (primary endpoint)
Secondary outcomes:
measure: Self reported pain. Assessed with KOOS and HOOS subscale on pain.
timeFrame: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
measure: Self reported quality of life (Qol). Assessed with KOOS and HOOS sub scale quality of life
timeFrame: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
measure: Self reported quality of life. Assessed with EQ5D questionnaire
timeFrame: baseline, one week preop., 3 month postop.(primary endpoint) and a 1 year follow up
measure: Observed physical function. Assessed with performance measures: 20 meter walk, 5 chair stands timed and one leg knee bendings/30 sec
timeFrame: baseline, one week preop. and 3 month postop.
measure: Muscle strength estimated as average muscle power for muscles of the hip and knee
timeFrame: baseline, 1 week preop. and 3 month postop
Other outcomes:
Locations:
city: Svendborg
country: Denmark
facility: Dept. of Orthopedics Svendborg Community Hospital
Study officials:
affiliation: University of Southern Denmark
name: Ewa Roos, Professor, PT, PhD
role: STUDY_CHAIR
affiliation: University of Southern Denmark
name: Allan Villadsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.