Community-based Rehabilitation and Fall Prevention Program After Total Knee Arthroplasty
Primary Purpose
Knee Osteoarthritis, Fall
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Fall prevention program
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Fall prevention, Total knee arthroplasty, Commnuity-based
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
Sites / Locations
- Queen Mary HospitalRecruiting
- Yan Chai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Fall prevention group
Usual care group
Asymptomatic control
Arm Description
Fall prevention program
Usual postoperative care
No intervention
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
11-point numeric pain rating scale
This scale quantify pain on a scale of 0 to 10. Higher the scores, higher the pain intensity
Chinese version Falls Efficacy Scale - International
To examine a person's confidence in avoiding a fall during 16 non-threatening activities of daily living.
Number of post-operative trips/falls
To quantify the number of trips/falls over 1 year after TKA
Chinese version geriatric depression scale
It consists of 15 questions to assess depression in older people
Chinese version Insomnia Severity Index
It assesses sleep problems and related difficulties
Physical Activity Scale for the Elderly
It evaluates leisure, physical, household and work-related activities over the last 7 days
Full Information
NCT ID
NCT03615638
First Posted
July 31, 2018
Last Updated
July 28, 2020
Sponsor
The Hong Kong Polytechnic University
Collaborators
Neuroscience Research Australia
1. Study Identification
Unique Protocol Identification Number
NCT03615638
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Neuroscience Research Australia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Fall
Keywords
Fall prevention, Total knee arthroplasty, Commnuity-based
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blinded 3-arm randomized controlled trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The orthopedic surgeons, outcomes assessor and statistician will be blinded.
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fall prevention group
Arm Type
Experimental
Arm Description
Fall prevention program
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Usual postoperative care
Arm Title
Asymptomatic control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Fall prevention program
Intervention Description
12-week fall prevention program (including warm-up, cool-down, education, Tai Chi, and lower limb strengthening)
Primary Outcome Measure Information:
Title
Chinese version of Knee Injury and Osteoarthritis Outcome Scale
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
11-point numeric pain rating scale
Description
This scale quantify pain on a scale of 0 to 10. Higher the scores, higher the pain intensity
Time Frame
1 year
Title
Chinese version Falls Efficacy Scale - International
Description
To examine a person's confidence in avoiding a fall during 16 non-threatening activities of daily living.
Time Frame
1 year
Title
Number of post-operative trips/falls
Description
To quantify the number of trips/falls over 1 year after TKA
Time Frame
1 year
Title
Chinese version geriatric depression scale
Description
It consists of 15 questions to assess depression in older people
Time Frame
1 year
Title
Chinese version Insomnia Severity Index
Description
It assesses sleep problems and related difficulties
Time Frame
1 year
Title
Physical Activity Scale for the Elderly
Description
It evaluates leisure, physical, household and work-related activities over the last 7 days
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnold Wong, PhD
Phone
852-2766-6741
Email
arnold.wong@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnold Wong, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Hoi Yan, MBBS, FRCS, FRCSE, FHKCOS
Phone
852 2255 4257
Email
yanchoi@hku.hk
Facility Name
Yan Chai Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun-Ming Chan, MBBS
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33573664
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.
Results Reference
derived
Learn more about this trial
Community-based Rehabilitation and Fall Prevention Program After Total Knee Arthroplasty
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