Total Knee ArthroplastyNCT03565380
Effectiveness of a Community-based Multi-modal Tai Chi Rehabilitation Program for Patients After Total Knee Arthroplasty
A study testing 12-week community-based multi-model Tai Chi rehabilitation program and Usual post-operative care in people with Total Knee Arthroplasty, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The rate of falls in patients after total knee arthroplasty (TKA) is high and related to lower limb muscle weakness and poor balance control. However, since routine post-TKA rehabilitation is uncommon, it is paramount to explore alternative strategies to enhance balance and physical functioning in post-TKA patients. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- 12-week community-based multi-model Tai Chi rehabilitation program and Usual post-operative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Nov 2018to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years or above;
- candidates for primary unilateral TKA who are placed on the TKA waiting list for less than 1 month before their surgery;
- living independently in the community
Who cannot join
- living in assisted living facilities, requiring nursing care, or planning to reside away from the hospital district within 1 year.
- unstable medical conditions,
- fracture of lower limbs,
- malignancy in the last five years,
- lower limb prosthesis/amputation,
- congenital defect that is considered to cause the present complaint,
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- systemic inflammatory and autoimmune diseases,
- previous osteotomy,
- neurological diseases (e.g. Parkinson's disease, stroke),
- blindness, revision TKA,
- complications after primary TKA,
- cognitive impairment with a Mini-Mental State Examination score < 19
- prior experience in practicing Tai Chi exercise for at least 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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: a Pilot Randomized Controlled Trial
The rate of falls in patients after total knee arthroplasty (TKA) is high and related to lower limb muscle weakness and poor balance control. However, since routine post-TKA rehabilitation is uncommon, it is paramount to explore alternative strategies to enhance balance and physical functioning in post-TKA patients. As Tai Chi is a proven strategy for improving balance in older people, the proposed study aims to determine the feasibility and acceptability of a 12-week community-based post-TKA multimodal Tai Chi program and to collect preliminary data with respect to the efficacy of such a program in improving balance and physical functioning in post-TKA patients as compared to usual postoperative care.
Read the detailed description
This is a single-blinded 2-arm RCT. TKA participants will be randomized to either a 12-week community-based rehabilitation program starting at 12 weeks after TKA, or usual post-operative care without outpatient physiotherapy. A third group of asymptomatic controls will be recruited to provide comparisons at various time points. All post-TKA participants will undergo five clinical assessments: 1 week before TKA, and at 6, 12, 24 and 52 weeks after TKA. The untreated asymptomatic controls will be assessed at baseline, and 12 and 52 weeks from baseline
- Conditions
- Total Knee Arthroplasty
- Being tested
- 12-week community-based multi-model Tai Chi rehabilitation program, Usual post-operative care, Untreated asymptomatic controls
- Keywords
- Tai Chi, Lower limb muscle strength, Balance, Rehabilitation, Multi-faceted intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week community-based multi-model Tai Chi rehabilitation programOther
Also called Fall prevention program
Participants will receive 12 x 90 minute sessions of supervised exercises over 12 weeks. In addition to usual care, supervised exercise will be held at the Center of Sports Training and Rehabilitation inside the University and each class will be restricted to no more than 8 participants to ensure sufficient personalized attention. Each training session involves warm-up together with stretching of lower extremity muscles, strengthening exercises of the major lower extremity muscle groups by Theraband, balancing exercise, Tai Chi training, and rest/ cool-down. All lower-extremity exercises will be performed bilaterally.
Usual post-operative careOther
No intervention will be provided
Untreated asymptomatic controlsOther
No intervention will be provided
| Study group | Role | What they receive |
|---|---|---|
| Patients with intervention | Experimental | 12-week community-based Tai Chi rehabilitation program starting at 12 weeks after TKA Receives: Other: 12-week community-based multi-model Tai Chi rehabilitation program |
| Patients without intervention | Experimental | usual post-operative care Receives: Other: Usual post-operative care |
| Asymptomatic controls | Experimental | untreated asymptomatic controls Receives: Other: Untreated asymptomatic controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment and rate of retention
The recruitment and attrition rates will be monitored on a monthly basis to determine the presence of any specific trends. The recruitment rate (all potential participants), retention and attrition rates (all randomized participants) and completion rates (all enrolled participants) will be assessed at the end of study. Reasons for ineligibility, and/or non-recruitment of eligible patients will be recorded and grouped into categories.
Measured: After 52 week post-TKA follow-up
Facilitators and barriers of the intervention
Attendance and exercise logbooks will be used to monitor non-adherence. The instructor will communicate with non-adherent participants to understand the reasons and barriers for non-adherence and to develop appropriate strategies to improve adherence. Furthermore, to assess the acceptability of the intervention, each participant in the intervention group will be invited to participate in a face-to-face or video call interviews semi-structured interview based on participants' preferences within 1 month after the final follow-up.
Measured: During the intervention and after 52 week post-TKA follow-up
Sample size estimation for the future definitive trial
Based on the standard deviation (SD) of The Chinese version of the Knee Injury and Osteoarthritis Outcome Scale (the higher the score, the better the performance )so as to inform the sample size calculation for the effectiveness trial.
Measured: After 52 week post-TKA follow-up
Self-reported physical function
The Chinese version of Knee Injury and Osteoarthritis Outcome Scale will be used to document self-reported physical function and to evaluate knee status before/after TKA
Measured: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Number of trips/falls
The number of trips, falls and fall-related injuries in the 12 months before baseline will be documented.
Measured: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Secondary outcomes (9)
Objective measures of static and dynamic stability
When wearing the sensors, participants will perform a tandem stance test with eyes open and eyes closed, the TUG and the 6MWT.
Measured: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Knee pain
It will be measured by an 11-point numeric pain rating scale, which ranges from 0 (no pain) to 10 (the worst imaginable pain). It documents the current, best, and worst pain in the last 24 hours. It will be used to record the pain intensity of participant's knee and other body parts, if appropriate.
Measured: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Depression
Depressive symptoms will be examined by the short form Chinese version of the Geriatric Depression Scale, which comprises 15 questions.
Measured: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Physical activity level
Physical activity will be assessed by the Physical Activity Scale for the Elderly (Chinese version), which is a 12-item questionnaire that documents leisure, physical, household and work-related activities over the last 7 days.
Measured: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Fear of falling
Concern of falling will be measured with the Falls Efficacy Scale, which showed good reliability and validity in measuring fear of falling in frail older people.
Measured: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Global impression of change
Symptom severity, treatment response and the efficacy of treatment 24-weeks post-TKA will be measured by the Global Impression of change scale.
Measured: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Joint range of motion
The ranges of motion of hip, knee, and ankle joints will be evaluated using a goniometer. These assessments are chosen because limited knee/ankle joint ranges have been reported as potential risk factors for falls.
Measured: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Balance assessment
The Brief-Balance Evaluation Systems test comprises six static and six dynamic tasks of different difficulty levels.
Measured: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Remote monitoring of physical activity
Participants' physical activity will be measured by a wearable sensor. accelerometer. The participant will wear ActiGraph on the right hip, near the iliac crest for 7 days except during sleeping, showering or bathing. Data from the vertical axis will be recorded in 15s epochs and be initialized using the normal filter. The data be classified into different activity levels by ActiLife V6.11.0: sedentary (0-99 counts/minute), light (100-2019 counts/minute), moderate (2020-5998 counts/minute), and vigorous (> 5999 counts/minute).
Measured: over 7 days at 1 week before TKA, 7 days during the 12th , 24th and 52th week after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start11 Nov 2018
- Primary completion30 Jun 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnold Wong, PhD, Principal investigator, The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565380
- Sponsor's protocol ID
- HSEARS20171225001AW
- Status last verified
- Mar 2022
- First submitted
- 30 May 2018
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33573664
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03565380
- Acronym / sponsor ID
- HSEARS20171225001AW
- Conditions
- Total Knee Arthroplasty
- Keywords
- Tai Chi, Lower limb muscle strength, Balance, Rehabilitation, Multi-faceted intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rate of falls in patients after total knee arthroplasty (TKA) is high and related to lower limb muscle weakness and poor balance control. However, since routine post-TKA rehabilitation is uncommon, it is paramount to explore alternative strategies to enhance balance and physical functioning in post-TKA patients. As Tai Chi is a proven strategy for improving balance in older people, the proposed study aims to determine the feasibility and acceptability of a 12-week community-based post-TKA multimodal Tai Chi program and to collect preliminary data with respect to the efficacy of such a program in improving balance and physical functioning in post-TKA patients as compared to usual postoperative care.
Detailed description
This is a single-blinded 2-arm RCT. TKA participants will be randomized to either a 12-week community-based rehabilitation program starting at 12 weeks after TKA, or usual post-operative care without outpatient physiotherapy. A third group of asymptomatic controls will be recruited to provide comparisons at various time points. All post-TKA participants will undergo five clinical assessments: 1 week before TKA, and at 6, 12, 24 and 52 weeks after TKA. The untreated asymptomatic controls will be assessed at baseline, and 12 and 52 weeks from baseline
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with intervention | Experimental | Other: 12-week community-based multi-model Tai Chi rehabilitation program12-week community-based Tai Chi rehabilitation program starting at 12 weeks after TKA |
| Patients without intervention | Experimental | Other: Usual post-operative careusual post-operative care |
| Asymptomatic controls | Experimental | Other: Untreated asymptomatic controlsuntreated asymptomatic controls |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years or above;
- candidates for primary unilateral TKA who are placed on the TKA waiting list for less than 1 month before their surgery;
- living independently in the community
Key exclusion criteria (13 listed)
- living in assisted living facilities, requiring nursing care, or planning to reside away from the hospital district within 1 year.
- unstable medical conditions,
- fracture of lower limbs,
- malignancy in the last five years,
- lower limb prosthesis/amputation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week community-based multi-model Tai Chi rehabilitation programAlso: Fall prevention programParticipants will receive 12 x 90 minute sessions of supervised exercises over 12 weeks. In addition to usual care, supervised exercise will be held at the Center of Sports Training and Rehabilitation inside the University and each class will be restricted to no more than 8 participants to ensure sufficient personalized attention. Each training session involves warm-up together with stretching of lower extremity muscles, strengthening exercises of the major lower extremity muscle groups by Theraband, balancing exercise, Tai Chi training, and rest/ cool-down. All lower-extremity exercises will be performed bilaterally. | Other | Patients with intervention |
| Usual post-operative careNo intervention will be provided | Other | Patients without intervention |
| Untreated asymptomatic controlsNo intervention will be provided | Other | Asymptomatic controls |
Primary outcome
Rate of recruitment and rate of retention
Time frame: After 52 week post-TKA follow-up
The recruitment and attrition rates will be monitored on a monthly basis to determine the presence of any specific trends. The recruitment rate (all potential participants), retention and attrition rates (all randomized participants) and completion rates (all enrolled participants) will be assessed at the end of study. Reasons for ineligibility, and/or non-recruitment of eligible patients will be recorded and grouped into categories.
Facilitators and barriers of the intervention
Time frame: During the intervention and after 52 week post-TKA follow-up
Attendance and exercise logbooks will be used to monitor non-adherence. The instructor will communicate with non-adherent participants to understand the reasons and barriers for non-adherence and to develop appropriate strategies to improve adherence. Furthermore, to assess the acceptability of the intervention, each participant in the intervention group will be invited to participate in a face-to-face or video call interviews semi-structured interview based on participants' preferences within 1 month after the final follow-up.
Sample size estimation for the future definitive trial
Time frame: After 52 week post-TKA follow-up
Based on the standard deviation (SD) of The Chinese version of the Knee Injury and Osteoarthritis Outcome Scale (the higher the score, the better the performance )so as to inform the sample size calculation for the effectiveness trial.
Self-reported physical function
Time frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
The Chinese version of Knee Injury and Osteoarthritis Outcome Scale will be used to document self-reported physical function and to evaluate knee status before/after TKA
Number of trips/falls
Time frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
The number of trips, falls and fall-related injuries in the 12 months before baseline will be documented.
9 secondary outcomes
Objective measures of static and dynamic stability
Time frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Knee pain
Time frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Depression
Time frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Physical activity level
Time frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Fear of falling
Time frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Global impression of change
Time frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Joint range of motion
Time frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Balance assessment
Time frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Remote monitoring of physical activity
Time frame: over 7 days at 1 week before TKA, 7 days during the 12th , 24th and 52th week after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 33573664Lo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnold Wong, PhD principal investigator
The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-week community-based multi-model Tai Chi rehabilitation program and Usual post-operative care in people with Total Knee Arthroplasty, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment and rate of retention (time frame: After 52 week post-TKA follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03565380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.