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

NCT ID: NCT03565380

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-11
• Study Completion Date: 2021-08-30

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

Conditions

Total Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Patients with intervention

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Patients without intervention

usual post-operative care

Group Type: EXPERIMENTAL

Usual post-operative care

Intervention Type: OTHER

No intervention will be provided

Asymptomatic controls

untreated asymptomatic controls

Group Type: EXPERIMENTAL

Untreated asymptomatic controls

Intervention Type: OTHER

No intervention will be provided

Interventions

12-week community-based multi-model Tai Chi rehabilitation 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.

Intervention Type: OTHER

Usual post-operative care

No intervention will be provided

Intervention Type: OTHER

Untreated asymptomatic controls

No intervention will be provided

Intervention Type: OTHER

Other Intervention Names

Fall prevention program

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnold Wong, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University, Department of Rehabilitation Sciences

Locations

The Hong Kong Polytechnic Univeristy

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 33573664 (View on PubMed)

Other Identifiers

HSEARS20171225001AW

Identifier Type: -

Identifier Source: org_study_id