Community-based Rehabilitation and Fall Prevention Program After Total Knee Arthroplasty

Study Overview
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Brief Summary
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Knee osteoarthritis (OA) is a common musculoskeletal disorder among older people. Since the prevalence of knee OA increases with age, it is anticipated that the prevalence and burden of knee OA will increase significantly given the aging population. Total knee arthroplasty (TKA) is used to treat patients with severe knee OA. While TKA has been shown to improve knee pain, function and quality of life of patients with knee OA, up to 50% of patients with post-TKA may suffer from falls within in the first year after TKA. Given that Tai Chi can significantly improve the balance and function of older people, a fall prevention program may improve balance, pain, and function of post-TKA patients. As such, the current 3-arm randomized controlled trial (RCT) aims to compare the effectiveness of a post-operative community-based fall prevention program in improving knee pain, function and balance of patients with unilateral TKA against a group of TKA patients receiving standard post-operative care, and age- and gender-matched asymptomatic controls over 1 year.

Detailed Description
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Osteoarthritis (OA) is the third most disabling musculoskeletal compliant in the world. Knee OA is the most common type of OA. Since the prevalence of knee OA increases with age, it is anticipated that the prevalence and burden of knee OA will increase significantly given the aging population. Total knee arthroplasty (TKA) is a surgical intervention for treating patients with severe knee OA. Research has found that TKA reduces knee pain, and improves patient's function and quality of life. However, studies have also found that patients with post-TKA may be more likely to fall as compared to age- and gender-matched asymptomatic counterparts. It is estimated that around 20% to 50% of patients fall within in the first year after TKA. As such, it is essential to improve the balance of post-TKA patients. Studies have found that Tai Chi can significantly improve the balance and function of older people. Therefore, a fall prevention program aiming at strengthening, proprioception, balance training, and behavioral modification may improve balance, pain, and function of post-TKA patients. As such, the current 3-arm randomized controlled trial (RCT) aims to compare the effectiveness of a post-operative community-based fall prevention program in improving knee pain, function and balance of patients with unilateral TKA with a group of patients receiving standard post-operative care, and age- and gender-matched asymptomatic controls over 1 year.

Official Title
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Effectiveness of a Community-based Post-operative Rehabilitation and Fall Prevention Program Following Total Knee Arthroplasty - a Randomized Controlled Trial

Conditions
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Knee Osteoarthritis, Fall

Intervention / Treatment
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* Other: Fall prevention program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants undergoing TKA for intervention group and usual postoperative care group Age- and gender-matched asymptomatic controls without knee pain in the last 12 months. Can speak and understand Cantonese/English. Exclusion Criteria: Living in assisted living facilities, requiring nursing care Medical 'red flag' conditions A history of cancer in the last five years Cauda equine syndrome Knee fracture Auto-immune disease (e.g. rheumatoid arthritis) even if they have OA Inflammatory or septic arthritis Systemic disease Amputation History of orthopedic or neurological surgery to the spine, pelvis or hips Neurological diseases (e.g. stroke or Parkinson's disease) Mini-Mental State Examination score < 24 Depression subscale score of Depression Anxiety Stress Scales > 21 Severe comorbidity leading to severe deterioration of quality of life or major healthcare utilization Osteochondritis dissecans Perthes' disease Plica disease Baker's cyst

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blinded 3-arm randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fall prevention group<br>Fall prevention program | Other: Fall prevention program<br>* 12-week fall prevention program (including warm-up, cool-down, education, Tai Chi, and lower limb strengthening)<br>|
| No Intervention: Usual care group<br>Usual postoperative care | |
| No Intervention: Asymptomatic control<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chinese version of Knee Injury and Osteoarthritis Outcome Scale | A 42-item questionnaire with 5 subscales to assess pain, symptoms, activities of daily living, sports and recreation function, and knee-related quality of life | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11-point numeric pain rating scale | This scale quantify pain on a scale of 0 to 10. Higher the scores, higher the pain intensity | 1 year | 
| Chinese version Falls Efficacy Scale - International | To examine a person's confidence in avoiding a fall during 16 non-threatening activities of daily living. | 1 year | 
| Number of post-operative trips/falls | To quantify the number of trips/falls over 1 year after TKA | 1 year | 
| Chinese version geriatric depression scale | It consists of 15 questions to assess depression in older people | 1 year | 
| Chinese version Insomnia Severity Index | It assesses sleep problems and related difficulties | 1 year | 
| Physical Activity Scale for the Elderly | It evaluates leisure, physical, household and work-related activities over the last 7 days | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fall prevention, Total knee arthroplasty, Commnuity-based