Efficacy of Preoperative Muscle Training on Postoperative Orthopaedic Surgery Recovery
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|ClinicalTrials.gov Identifier: NCT03483519|
Recruitment Status : Active, not recruiting
First Posted : March 30, 2018
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty Osteoarthritis||Other: Rehabilitation Other: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Preoperative Muscle Training on Postoperative Recovery and Function in Patients Undergoing Total Hip or Knee Replacement|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Patients in the Prehabilitation Group and are randomized to the Experimental Group will undergo a 6 Week Exercise Program plus Standard of Care
Patients randomized to the Experimental Group will undergo a 6 Week Exercise Program plus Standard of Care
Active Comparator: Standard of Care
Patients in the Standard of Care will not receive an additional an exercise program, patients will receive the usual care received by all orthopaedic patients.
Other: Standard of Care
Patients randomized to the Active Comparator Group will not undergo an exercise program, patients will receive the standard of care used at The Ottawa Hospital for hip and knee surgeries. Standard of care protocol will be explained by each individual surgeon.
- HOOS or KOOS Questionnaire to assess self-reported pain [ Time Frame: 12 months ]The Hip Disability and Osteoarthritis Outcome Score (HOOS) or Knee Injury and Osteoarthritis Outcome Score (KOOS). A standardized set of questions to assess the function of the hip or knee (dependent on which surgery the patient is undergoing). The KOOS/HOOS are comprised of 6 sections: 1) Symptoms (3 items), 2) Stiffness (2 items), 3) Pain (10 items), 4) Function Daily Living (17 items), 5) Function/Sports and Recreation (4 items), 6) Quality of Life (4 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
- Timed-Up-and-Go (TUG) [ Time Frame: 12 months ]Assesses the time that a patient takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down. Time will be measured in seconds.
- Timed Stair Test [ Time Frame: 12 months ]Assesses the time that a patient takes to ascend and descend a flight of 10 stair, while holding on to the handrail. Time will be measured in seconds.
- Length of hospital stay [ Time Frame: 1 month ]Length of stay will be calculated from the date of surgery to discharge from an inpatient bed. Length of stay will be measured in days until hospital discharge.
- Post-surgical Complications [ Time Frame: 30 days ]Post-operative complications and adverse events will be collected using the Ottawa Hospital data warehouse coding data.
- Hip or Knee Muscle Strength [ Time Frame: 12 months ]For patients undergoing hip surgery, hip abductor strength will be assessed with a hand held dynamometer with the patient in the side-lying position. For patients undergoing knee surgery, quadriceps strength will be measured with a hand held dynamometer with the patient in the supine position and the knee flexed at 60 degrees. A dynamometer is a small machine hand-held by the research assistant that you push on with your leg in order to measure the strength of your muscle (measured in kilograms). The average of three trials will be used. Absolute (affected side only) and relative (difference between non-affected and affected side) strength values will be calculated. Muscle strength will be assessed at baseline, two weeks before surgery, six months and one year after surgery.
- Muscle Mass measured with dual-energy x-ray absorptiometry [ Time Frame: 12 months ]Body weight and height will be measured. A method called dual-energy x-ray (DXA) will also be used to measure bone density, percent fat and percent lean body mass. The patient will lie on an examination table, wearing a hospital gown, while a low-intensity x-ray will scan the entire body. The measurement takes approximately 20 minutes. The only risk is a minimal x-ray exposure of less than 0.003 mSv, which is less than the natural exposure to sunlight during the course of 1 day. Muscle mass will be assessed at baseline, two weeks before surgery, six months and one year after surgery.
- Generic Health Status measured by the Questionnaire EQ-5D-5L [ Time Frame: 12 months ]A standardized set of questions to assess generic health status. The EQ-5D-5L questionnaire consists of 2 pages: the EQ-5D descriptive system (5 items) and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The patient is asked to tick the box that is most appropriate to their health within the 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled as 100 ('The best health you can imagine) and 0 (The worst health you can imagine).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483519
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Paul Beaule, MD||Ottawa Hospital|