Efficacy of Preoperative Muscle Training on Postoperative Orthopaedic Surgery Recovery

Osteoarthritis Clinical Trial

Official title:

Efficacy of Preoperative Muscle Training on Postoperative Recovery and Function in Patients Undergoing Total Hip or Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483519
• Other study ID #: 20150684
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: October 14, 2020

Study information

• Verified date: June 2021
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of a preoperative muscle training program on hip or knee TJA (Total Joint Arthroplasty). It aims to improve hospital discharge readiness and functional capacity in both the short and long-term. One of the key factors affecting recovery after TJA is how well the patient functions before their surgery. Thus, interventions addressing preoperative function are expected to be beneficial.

Description:

Although total hip or knee joint replacement is beneficial in treating severe hip or knee osteoarthritis, a significant number of patients take longer to recover in the hospital or have a non-optimal quality of life after the surgery. These patients often have difficulties in accomplishing basic essential everyday tasks such as walking and stair climbing, both shortly and long after surgery. It has been previously shown through research that difficulties to do basic tasks before surgery delays recovery and negatively affects long-term function. It has also been shown that these difficulties are associated with reduced strength in hip or knee muscles present before surgery, caused by lack of activity of patients. This study will determine if a hip or knee muscle strengthening exercise program accomplished before surgery can improve hospital recovery, capacity to accomplish basic activities, and quality of life two days, six weeks and six months after joint replacement surgery. If this exercise program is shown to be beneficial, it will be easily used by patients when waiting for their surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 and older undergoing unilateral total hip or knee arthroplasty due to osteoarthritis;

• WOMAC functional subscale less than 66.5/100.

Exclusion Criteria:

• Patients under 18 years of age;

• Patients undergoing joint revision on the affected side;

• patients under the same day discharge protocol;

• Patients undergoing bilateral arthroplasty;

• Patients suffering from other previously diagnosed lower-limb problems limiting their capacity to accomplish the exercise program;

• Patients having surgery in less than 16 weeks after verbal consent;

• Patients unable or unwilling to commit to required study follow-ups;

• Patients with no fixed address;

• Patients with a cognitive impairment that may preclude questionnaire completion;

• Pregnant or suspected pregnant women as dual-energy x-ray (DXA) used in this study may be harmful to a fetus.

Related Conditions & MeSH terms

• Arthroplasty
• Osteoarthritis

Intervention

Other:
• Rehabilitation
Patients randomized to the Experimental Group will undergo a 6 Week Exercise Program plus Standard of Care
• 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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	The Ottawa Hospital Academic Medical Association

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Sled EA, Khoja L, Deluzio KJ, Olney SJ, Culham EG. Effect of a home program of hip abductor exercises on knee joint loading, strength, function, and pain in people with knee osteoarthritis: a clinical trial. Phys Ther. 2010 Jun;90(6):895-904. doi: 10.2522/ptj.20090294. Epub 2010 Apr 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HOOS or KOOS Questionnaire to assess self-reported pain	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.	12 months
Secondary	Timed-Up-and-Go (TUG)	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.	12 months
Secondary	Timed Stair Test	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.	12 months
Secondary	Length of hospital stay	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.	1 month
Secondary	Post-surgical Complications	Post-operative complications and adverse events will be collected using the Ottawa Hospital data warehouse coding data.	30 days
Secondary	Hip or Knee Muscle Strength	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.	12 months
Secondary	Muscle Mass measured with dual-energy x-ray absorptiometry	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.	12 months
Secondary	Generic Health Status measured by the Questionnaire EQ-5D-5L	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).	12 months