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

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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis; Fall
• Intervention / Treatment: Other: Fall prevention program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Contact: Chun Hoi Yan, MBBS, FRCS, FRCSE, FHKCOS; Phone Number: 852 2255 4257; Email: yanchoi@hku.hk
  • Hong Kong, Hong Kong
    • Recruiting
    • Yan Chai Hospital
    • Contact: Chun-Ming Chan, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Neuroscience Research Australia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (ACTUAL): August 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; Fall prevention; Commnuity-based
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HSEARS20171225001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No