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
1 other identifier
interventional
78
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Oct 2018
Longer than P75 for not_applicable knee-osteoarthritis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2018
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJuly 30, 2020
July 1, 2020
3.3 years
July 31, 2018
July 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
11-point numeric pain rating scale
1 year
Chinese version Falls Efficacy Scale - International
1 year
Number of post-operative trips/falls
1 year
Chinese version geriatric depression scale
1 year
Chinese version Insomnia Severity Index
1 year
- +1 more secondary outcomes
Study Arms (3)
Fall prevention group
EXPERIMENTALFall prevention program
Usual care group
NO INTERVENTIONUsual postoperative care
Asymptomatic control
NO INTERVENTIONNo intervention
Interventions
12-week fall prevention program (including warm-up, cool-down, education, Tai Chi, and lower limb strengthening)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Queen Mary Hospital
Hong Kong, Hong Kong
Yan Chai Hospital
Hong Kong, Hong Kong
Related Publications (1)
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.
PMID: 33573664DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arnold Wong, PhD
The Hong Kong Polytechnic University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The orthopedic surgeons, outcomes assessor and statistician will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 31, 2018
First Posted
August 6, 2018
Study Start
October 1, 2018
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
July 30, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share