Community-based Rehabilitation and Fall Prevention Program After Total Knee Arthroplasty

NCT ID: NCT03615638

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-12-31

Brief Summary

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Knee osteoarthritis (OA) is a common musculoskeletal disorder among older people. Since the prevalence of knee OA increases with age, it is anticipated that the prevalence and burden of knee OA will increase significantly given the aging population.

Total knee arthroplasty (TKA) is used to treat patients with severe knee OA. While TKA has been shown to improve knee pain, function and quality of life of patients with knee OA, up to 50% of patients with post-TKA may suffer from falls within in the first year after TKA. Given that Tai Chi can significantly improve the balance and function of older people, a fall prevention program may improve balance, pain, and function of post-TKA patients.

As such, the current 3-arm randomized controlled trial (RCT) aims to compare the effectiveness of a post-operative community-based fall prevention program in improving knee pain, function and balance of patients with unilateral TKA against a group of TKA patients receiving standard post-operative care, and age- and gender-matched asymptomatic controls over 1 year.

Detailed Description

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Osteoarthritis (OA) is the third most disabling musculoskeletal compliant in the world. Knee OA is the most common type of OA. Since the prevalence of knee OA increases with age, it is anticipated that the prevalence and burden of knee OA will increase significantly given the aging population.

Total knee arthroplasty (TKA) is a surgical intervention for treating patients with severe knee OA. Research has found that TKA reduces knee pain, and improves patient's function and quality of life. However, studies have also found that patients with post-TKA may be more likely to fall as compared to age- and gender-matched asymptomatic counterparts. It is estimated that around 20% to 50% of patients fall within in the first year after TKA. As such, it is essential to improve the balance of post-TKA patients.

Studies have found that Tai Chi can significantly improve the balance and function of older people. Therefore, a fall prevention program aiming at strengthening, proprioception, balance training, and behavioral modification may improve balance, pain, and function of post-TKA patients.

As such, the current 3-arm randomized controlled trial (RCT) aims to compare the effectiveness of a post-operative community-based fall prevention program in improving knee pain, function and balance of patients with unilateral TKA with a group of patients receiving standard post-operative care, and age- and gender-matched asymptomatic controls over 1 year.

Conditions

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Knee Osteoarthritis Fall

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blinded 3-arm randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
The orthopedic surgeons, outcomes assessor and statistician will be blinded.

Study Groups

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Fall prevention group

Fall prevention program

Group Type EXPERIMENTAL

Fall prevention program

Intervention Type OTHER

12-week fall prevention program (including warm-up, cool-down, education, Tai Chi, and lower limb strengthening)

Usual care group

Usual postoperative care

Group Type NO_INTERVENTION

No interventions assigned to this group

Asymptomatic control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fall prevention program

12-week fall prevention program (including warm-up, cool-down, education, Tai Chi, and lower limb strengthening)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants undergoing TKA for intervention group and usual postoperative care group
* Age- and gender-matched asymptomatic controls without knee pain in the last 12 months.
* Can speak and understand Cantonese/English.

Exclusion Criteria

* Living in assisted living facilities, requiring nursing care
* Medical 'red flag' conditions
* A history of cancer in the last five years
* Cauda equine syndrome
* Knee fracture
* Auto-immune disease (e.g. rheumatoid arthritis) even if they have OA
* Inflammatory or septic arthritis
* Systemic disease
* Amputation
* History of orthopedic or neurological surgery to the spine, pelvis or hips
* Neurological diseases (e.g. stroke or Parkinson's disease)
* Mini-Mental State Examination score \< 24
* Depression subscale score of Depression Anxiety Stress Scales \> 21
* Severe comorbidity leading to severe deterioration of quality of life or major healthcare utilization
* Osteochondritis dissecans
* Perthes' disease
* Plica disease
* Baker's cyst
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Neuroscience Research Australia

OTHER

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Dr Arnold Wong Yu Lok

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arnold Wong, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Yan Chai Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Arnold Wong, PhD

Role: CONTACT

852-2766-6741

Facility Contacts

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Chun Hoi Yan, MBBS, FRCS, FRCSE, FHKCOS

Role: primary

852 2255 4257

Chun-Ming Chan, MBBS

Role: primary

References

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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

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HSEARS20171225001

Identifier Type: -

Identifier Source: org_study_id

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