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

NCT03565380 | Completed

• 1 other identifier: HSEARS20171225001AW
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Total Knee Arthroplasty

Keywords

Tai Chi; Lower limb muscle strength; Balance; Rehabilitation; Multi-faceted intervention

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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

  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.

  1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups

Secondary Outcomes (9)

• Objective measures of static and dynamic stability

  1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups

• Knee pain

  1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups

• Depression

  1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups

• Physical activity level

  1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups

• Fear of falling

  1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups

Study Arms (3)

Patients with intervention

EXPERIMENTAL

12-week community-based Tai Chi rehabilitation program starting at 12 weeks after TKA

Other: 12-week community-based multi-model Tai Chi rehabilitation program

Patients without intervention

EXPERIMENTAL

usual post-operative care

Other: Usual post-operative care

Asymptomatic controls

EXPERIMENTAL

untreated asymptomatic controls

Other: Untreated asymptomatic controls

Interventions

12-week community-based multi-model Tai Chi rehabilitation program OTHER

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.

Also known as: Fall prevention program

Patients with intervention

Usual post-operative care OTHER

No intervention will be provided

Patients without intervention

Untreated asymptomatic controls OTHER

No intervention will be provided

Asymptomatic controls

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic Univeristy

Hong Kong, Hong Kong

Location

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: 33573664 DERIVED

Study Officials

• Arnold Wong, PhD

  The Hong Kong Polytechnic University, Department of Rehabilitation Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 21, 2018
• Study Start: November 11, 2018
• Primary Completion: June 30, 2021
• Study Completion: August 30, 2021
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)