Preoperative Exercise in Patients Undergoing Total Hip or Knee Replacement

Study Overview
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Brief Summary
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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.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: Preoperative neuromuscular exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Knee Intervention<br>Patients undergoing Total Knee Replacement. Exercise 8-10 weeks preoperatively | Other: Preoperative neuromuscular exercise<br>* 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<br>|
| No Intervention: Knee Control<br>Patients undergoing Total Knee Replacement. Receives standard instructions | |
| Experimental: Hip Intervention<br>Patient undergoing Total Hip Replacement. Exercise 8-10 weeks preoperatively | Other: Preoperative neuromuscular exercise<br>* 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<br>|
| No Intervention: Hip Control<br>Patients undergoing Total Hip Replacement. Receives standard instructions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Self reported quality of life. Assessed with EQ5D questionnaire |  | 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 |  | baseline, one week preop. and 3 month postop. | 
| Muscle strength estimated as average muscle power for muscles of the hip and knee |  | baseline, 1 week preop. and 3 month postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative, Exercise, Joint Replacement, Knee, Hip