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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03615638
• Other study ID #: HSEARS20171225001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: The Hong Kong Polytechnic University
• Contact: Arnold Wong, PhD
• Phone: 852-2766-6741
• Email: arnold.wong[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Fall prevention program
12-week fall prevention program (including warm-up, cool-down, education, Tai Chi, and lower limb strengthening)

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Yan Chai Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Neuroscience Research Australia

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of post-operative trips/falls	To quantify the number of trips/falls over 1 year after TKA	1 year
Secondary	Chinese version geriatric depression scale	It consists of 15 questions to assess depression in older people	1 year
Secondary	Chinese version Insomnia Severity Index	It assesses sleep problems and related difficulties	1 year
Secondary	Physical Activity Scale for the Elderly	It evaluates leisure, physical, household and work-related activities over the last 7 days	1 year