Pre-operative Rehabilitation Exercise Program for Total Knee Arthroplasty

NCT ID: NCT00493142

Last Updated: 2022-07-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2021-11-25

Brief Summary

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The purpose of this study is to determine whether a pre-operative home rehabilitation exercise program designed for knee replacements is more effective than pre-operative usual care.

Detailed Description

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Patients with lower levels of function prior to total knee arthroplasty (TKA) attain lower functional endpoints after surgery. Therapeutic exercise improves function in patients with arthritis of the knee, yet little evidence has examined the impact of pre-operative exercise for TKA.

Single blinded randomized clinical trial comparing a pre-operative home exercise program to pre-operative usual care for patients who are waiting for TKA.Comparison group is usual care within the health region which does not include pre-operative rehabilitation program.

Primary outcome: WOMAC function subscale. Secondary outcomes: 1) quality of life; 2) ambulation; 3) self-efficacy; 4) anxiety; 5) patient satisfaction; 6) cost-effectiveness of this intervention.

Total Enrollment: 230 patients

If the intervention improves function prior to surgery, results will be clinically applicable for patients waiting for surgery

Conditions

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Osteoarthritis Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Usual care

Usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Exercise

Exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Interventions

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Exercise

Intervention Type OTHER

Usual care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* primary unilateral total knee arthroplasty
* poor functional status (WOMAC=50 or greater)
* 50 yrs or older
* reside within health region
* understands English

Exclusion Criteria

* unicompartmental total knee arthroplasty
* revision surgery
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Heritage Foundation for Medical Research

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allyson Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Lauren Beaupre, PhD

Role: STUDY_DIRECTOR

Capital Health- UAH

Locations

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University of Alberta- Capital Health

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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B-060605

Identifier Type: -

Identifier Source: org_study_id

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