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Completed

NCT Number: NCT00493142

Pre-operative Rehabilitation Exercise Program for Total Knee Arthroplasty

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.

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Key information

Conditions

Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta- Capital Health

Edmonton, Alberta, T6G 2G4, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Usual Care

Other

Primary outcomes

  1. Self-reported function

    Time frame: 5 evaluations within 6 months after surgery

    Self-reported function

Secondary outcomes

  1. Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction

    Time frame: 5 evaluations within 6 months after surgery

    Quality of life

  2. self-efficacy

    Time frame: 5 evaluations within 6 months after surgery

    self-efficacy

  3. ambulation, anxiety and patient satisfaction

    Time frame: 5 evaluations within 6 months after surgery

    ambulation

  4. anxiety

    Time frame: 5 evaluations within 6 months after surgery

    anxiety

  5. patient satisfaction

    Time frame: 5 evaluations within 6 months after surgery

    patient satisfaction

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Heritage Foundation for Medical Research
  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Impact of a Pre-operative Rehabilitation Exercise Program for Patients With Severe Dysfunction Awaiting Total Knee Arthroplasty

Acronym: PREP

Important dates

Study start
2008
Primary completion
2013
Study completion
2021
First posted
Jun 28, 2007
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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