search
Back to results

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
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Fall prevention, Total knee arthroplasty, Commnuity-based

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 31, 2018
Last Updated
July 28, 2020
Sponsor
The Hong Kong Polytechnic University
Collaborators
Neuroscience Research Australia
search

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

We'll reach out to this number within 24 hrs