Clinical trial NCT03615638: Community-based Rehabilitation and Fall Prevention Program After Total Knee Arthroplasty
Official title: Effectiveness of a Community-based Post-operative Rehabilitation and Fall Prevention Program Following Total Knee Arthroplasty - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Fall
Keywords: Fall prevention
Total knee arthroplasty
Commnuity-based
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Neuroscience Research Australia
First posted: 2018-08-06
Enrollment: 78
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded 3-arm randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Chinese version of Knee Injury and Osteoarthritis Outcome Scale
timeFrame: 1 year
Secondary outcomes:
measure: 11-point numeric pain rating scale
timeFrame: 1 year
measure: Chinese version Falls Efficacy Scale - International
timeFrame: 1 year
measure: Number of post-operative trips/falls
timeFrame: 1 year
measure: Chinese version geriatric depression scale
timeFrame: 1 year
measure: Chinese version Insomnia Severity Index
timeFrame: 1 year
measure: Physical Activity Scale for the Elderly
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Yan Chai Hospital
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Arnold Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lo CWT, Brodie MA, Tsang WWN, Yan CH, Lam PL, Chan CM, Lord SR, Wong AYL. Acceptability and feasibility of a community-based strength, balance, and Tai Chi rehabilitation program in improving physical function and balance of patients after total knee arthroplasty: study protocol for a pilot randomized controlled trial. Trials. 2021 Feb 11;22(1):129. doi: 10.1186/s13063-021-05055-5.