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Effectiveness of a Community-based Tai Chi Rehabilitation Program for Patients After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03565380
Recruitment Status : Unknown
Verified May 2018 by The Hong Kong Polytechnic University.
Recruitment status was:  Not yet recruiting
First Posted : June 21, 2018
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
The Hong Kong Polytechnic University

Brief Summary:
Total knee arthroplasty (TKA) is the most common surgical intervention for patients with end-stage knee osteoarthritis. Although total knee arthroplasty has been shown to improve patients' pain and physical function, up to 60% of patients may fall within the first year after surgery. The pilot study has shown that patients at 1 year after TKA still display poor walking performance and balance control than age- and gender-matched asymptomatic controls. While the previous randomized controlled trials have demonstrated that Tai Chi can significantly improve the balance and physical performance of patients with knee osteoarthritis or other diseases (e.g., stroke), no randomized controlled trials have been conducted to investigate the benefits of postoperative Tai Chi rehabilitation on patients with TKA. The proposed study will bridge this gap by evaluating the effect of a community-based Tai Chi rehabilitation program on the balance and function of patients at 1 year after TKA.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Other: 12-week community-based Tai Chi rehabilitation program Other: Usual post-operative care without outpatient physiotherapy Other: Untreated asymptomatic controls Not Applicable

Detailed Description:

This study is a single-blinded 3-arm RCT that will involve 3 groups: (1) 12-week community-based Tai Chi rehabilitation program starting at 12 weeks after TKA, (2) usual post-operative care without outpatient physiotherapy, and (3) untreated asymptomatic controls. All post-TKA participants in the RCT will undergo 5 clinical assessments at 1 week before TKA, and 6, 12, 24 and 52 weeks after TKA. Two orthopedic surgeons will use a standard parapatellar approach using posterior-stabilized TKA (DePuy, Warsaw, USA). Asymptomatic controls will be assessed at baseline, and 12 and 52 weeks from baseline. It is hypothesized that patients in the Tai Chi group will show significantly better physical function and balance control, and lower fall rates than patients receiving usual post-operative care. The balance control of the Tai Chi group participants will approach that of age-matched asymptomatic controls.

Participants scheduled for TKA will be recruited from the Osteoarthritis Clinic in Queen Mary Hospital, where approximately 480 to 520 TKAs are performed annually. Dr. Chun-Hoi Yan (one of the co-investigators) and orthopedic surgeons of the joint replacement team will identify patients who meet the selection criteria. A research personnel will explain the details of the study to potential participants and conduct the Mini-Mental State Examination on-site, if the examination has not been performed before. After obtaining the written consent, participants will be scheduled for the clinical assessments in the Physiotherapy Department of Queen Mary Hospital.

Untreated asymptomatic controls will be recruited from dedicated community centres through posters. The same selection criteria will be applied to asymptomatic controls. Additionally, these controls should not have knee pain in the last 3 years nor a prior history of TKA. All controls will undergo identical clinical assessments by a registered physiotherapist at The Hong Kong Polytechnic University.

Upon completion of the baseline assessment, the TKA participants will be formally recruited into the study and randomised into intervention or control groups. Permuted blocks (sizes: 2, 4 and 6) using a computer generated random number schedule will be performed to determine the randomisation order. Allocation will be concealed by using central randomisation performed by Hong Kong Polytechnic University personnel uninvolved in the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The reassessments at 6-, 12-, 24-, and 52 weeks, and prospective falls evaluation will be conducted by assessors blinded to group allocation. Due to the nature of the trial, the certified Tai Chi instructor who provides treatments and participants will not be blinded to group allocation.
Primary Purpose: Prevention
Official Title: Effectiveness of a Community-based Tai Chi Rehabilitation Program in Improving Physical Function and Balance of Patients After Total Knee Arthroplasty - A Randomized Controlled Trial
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with intervention
12-week community-based Tai Chi rehabilitation program starting at 12 weeks after TKA
Other: 12-week community-based Tai Chi rehabilitation program
The program will be held at the Flora Ho Sports Centre at The University of Hong Kong twice per week (90 minutes each) for 12 weeks. Each training session will involve warm-up, Tai Chi training, and cool down exercises. A certified "Tai Chi for Arthritis" instructor will teach the 12-form Sun style Tai Chi alongside behavioral modification education in a group of 6 to 8 participants. Participants will be instructed to practice at least 30 minutes of daily Tai Chi at home. Upon completion of the 12-week intervention, participants will be encouraged to continue their home exercises. A research personnel will phone participants once a month to remind them to document their Tai Chi practice duration on the exercise logbooks until the post-operative 52-week follow-up.
Other Name: Fall prevention program

Experimental: Patients without intervention
usual post-operative care without outpatient physiotherapy,
Other: Usual post-operative care without outpatient physiotherapy
No intervention will be provided

Experimental: Asymptomatic controls
untreated asymptomatic controls
Other: Untreated asymptomatic controls
No intervention will be provided




Primary Outcome Measures :
  1. Change from baseline physical function [ Time Frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups ]

    Chinese version of Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a 24-item questionnaire with 3 subscales assessing: pain (5 items), stiffness (2 items) and physical function (17 items). Each item is rated on a 5-point Likert scale ranging from 0 to 4. Higher scores indicate poorer outcomes.

    WOMAC has been used to evaluate knee status before/after TKA. The physical function subscale score will be used for data analysis


  2. Change from baseline risk of falls [ Time Frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups ]
    Short form Physiological Profile Assessment (PPA) is a low-tech and simple fall risk assessment tool examining 5 physiological domains: vision (edge contrast sensitivity), leg proprioception (a lower limb joint matching task), quadriceps strength (as meas


Secondary Outcome Measures :
  1. Knee pain [ Time Frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups ]
    It will be measured by an 11-point numeric pain rating scale (NPRS), 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. The NPRS has been used as a gold standard for pain measurement given its high reliability, sensitivity and validity

  2. Number of trips/falls [ Time Frame: every month by mail for 12 months ]
    The number of trips, falls or related injuries in the last 12 months or between the follow-up periods will be asked using the trip/fall diary. A trip is defined as momentary loss of balance because the swing foot is obstructed while walking. A fall is defined as inadvertently coming down to the ground that is unrelated to a loss of consciousness, a major intrinsic event (e.g., stroke, or seizure), or a sudden blow

  3. Depression [ Time Frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups ]
    Depression of participants will be examined by the short form Chinese version geriatric depression scale (GDS). The GDS comprises 15 questions. It is interpreted as no depression, probable depression, definite depression if GDS scores are < 5; between >5 and < 10; and >10, respectively. Participants with GDS > 10 will be referred to specialists for further consultation if our medical co-applicant deems appropriate.

  4. Insomnia [ Time Frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups ]
    Chinese version Insomnia Severity Index will assess the severity and impact of insomnia. It consists of 7 items examining difficulties in initiating and maintaining sleep, early morning awakening, noticeability of the sleeping problems to others, effects on daily functioning, and level of satisfaction and distress in relation to existing sleep pattern. Each item comprises a 4-point Likert scale with "1" indicating "inappropriate" and "4" representing "most appropriate".

  5. Physical activity level [ Time Frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups ]
    Physical activity will be assessed by the Physical Activity Scale for the Elderly (Chinese version), which is a 12-item questionnaire asking the leisure, physical, household and work-related activities over the last 7 days. It has demonstrated very good reliability and fair-to-moderate associations with psychosocial and physical measures in older adults aged 65 years or above

  6. Global impression of change [ Time Frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups ]

    The patient's perceived changes after the Tai Chi rehabilitation will be measured by the Global Impression of change scale, which is a 7-point numerical rating scale.

    The value of 1 indicates very much improved, while 7 means very much worse.


  7. Joint range of motion [ Time Frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups ]
    The ranges of motion of hip, knee, and ankle joints will be evaluated by a goniometer. These assessments are chosen because limited knee/ankle joint ranges have been reported as potential risk factors for falls

  8. Balance [ Time Frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups ]
    The Mini-Balance Evaluation Systems test (miniBESTest) will be used to determine the participant's balance control, and the fall risk based on 14 static and dynamic tasks of different difficulty: sit-to-stand; rising to toes; single leg stance; forward compensatory stepping correction; backward compensatory stepping correction; lateral compensatory stepping correction; stance with eyes open on a firm surface; stance with eyes closed on a foam surface; stance with eyes closed on a ramp; walking with different speeds; walking with head turns; walking with pivot turns; stepping over obstacles; and TUG. This 14-item test evaluates the performance of each item based on a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. This test can evaluate the potential causes of balance problem, which can help plan fall prevention strategies.

  9. Objective measures of static and dynamic stability [ Time Frame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups ]
    Two wearable inertial sensors (OPAL, APDM Inc., Portland, USA; sampling frequency of 128Hz) will be used to assess the dynamic balance of participants during functional tasks. Each sensor comprises a tri-axial accelerometer and a triaxial gyroscope. One sensor will be strapped to the participant's waist using a belt, while another sensor will be attached to a plastic helmet at the vertex of participant's head. When wearing the sensors, participants will perform tandem stance with eyes open and eyes closed, and 6MWT. A customized MATLAB software program will be used to analyze the balance data during these activities.

  10. 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 ]
    Participants' physical activity will be measured by the ActiGraph GT3X-BT accelerometer (ActiGraph, Pensacola, FL, USA). The participant will wear ActiGraph GT3X-BT 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 (AG-Norm). 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 60 years or above;
  2. candidates for primary unilateral TKA who are placed on the TKA waiting list for less than 1 month before their surgery;
  3. living independently in the community

Exclusion Criteria:

  1. They are living in assisted living facilities, requiring nursing care, or planning to reside away from the hospital district within 1 year.
  2. unstable medical conditions,
  3. fracture of lower limbs,
  4. malignancy in the last five years,
  5. lower limb prosthesis/amputation,
  6. congenital defect that is considered to cause the present complaint,
  7. systemic inflammatory and autoimmune diseases,
  8. previous osteotomy,
  9. neurological diseases (e.g. Parkinson's disease, stroke),
  10. blindness, revision TKA,
  11. complications after primary TKA,
  12. and cognitive impairment with a Mini-Mental State Examination score < 19

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565380


Contacts
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Contact: Arnold Wong, PhD 27666741 arnold.wong@polyu.edu.hk
Contact: Cathy Lo, Mphil 60772918 cathylwt.lo@connect.polyu.hk

Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Arnold Wong, PhD The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
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Responsible Party: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03565380    
Other Study ID Numbers: HSEARS20171225001AW
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Hong Kong Polytechnic University:
Tai Chi
Fall
Balance
Post operative
Elderly