Clinical trial NCT03565380: Effectiveness of a Community-based Multi-modal Tai Chi Rehabilitation Program for Patients After Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Tai Chi
Lower limb muscle strength
Balance
Rehabilitation
Multi-faceted intervention
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 53
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility 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. 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. cognitive impairment with a Mini-Mental State Examination score \< 19
13. prior experience in practicing Tai Chi exercise for at least 3 months

Primary outcomes:
measure: Rate of recruitment and rate of retention
timeFrame: After 52 week post-TKA follow-up
measure: Facilitators and barriers of the intervention
timeFrame: During the intervention and after 52 week post-TKA follow-up
measure: Sample size estimation for the future definitive trial
timeFrame: After 52 week post-TKA follow-up
measure: Self-reported physical function
timeFrame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
measure: Number of trips/falls
timeFrame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
Secondary outcomes:
measure: Objective measures of static and dynamic stability
timeFrame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
measure: Knee pain
timeFrame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
measure: Depression
timeFrame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
measure: Physical activity level
timeFrame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
measure: Fear of falling
timeFrame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
measure: Global impression of change
timeFrame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
measure: Joint range of motion
timeFrame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
measure: Balance assessment
timeFrame: 1-week before TKA, 6-, 12-, 24- and 52-week post-TKA follow-ups
measure: Remote monitoring of physical activity
timeFrame: over 7 days at 1 week before TKA, 7 days during the 12th , 24th and 52th week after
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic Univeristy
Study officials:
affiliation: The Hong Kong Polytechnic University, Department of Rehabilitation Sciences
name: Arnold Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.