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Independent Exercise Compared With Formal Rehabilitation Following Primary Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01826305
Recruitment Status : Terminated
First Posted : April 8, 2013
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

In this study we plan to compare the efficacy of independent exercises performed by the patients at home to formal rehabilitation therapy following primary total knee replacement. Patients will be randomized to these two cohorts at enrollment into the study and followed prospectively. Patients randomized to the formal rehabilitation cohort will receive a prescription for therapy for twelve weeks. Patients randomized to the independent exercise cohort will receive online access to a twelve-week protocol of exercises to perform at home to strengthen and improve function of the replaced joint.

At enrollment, a baseline evaluation will be conducted to capture demographics, height, weight, primary diagnosis, medical comorbidities, and social supports as well as completion of the selected outcome measure, American Knee Society (AKS) Score, Knee and Osteoarthritis Outcome Score (KOOS). Secondary outcomes will include the measurement of health status with use of the Short Form-12v2 (SF-12v2) and activity level with the University of California, Los Angeles (UCLA) Activity Score. At the twelve-week, six-month and twelve-month follow-up visits, the study subjects will complete the KOOS, SF-12v2, and UCLA Activity Score questionnaires. Statistical analysis will be performed to compare the outcomes between the two cohorts.

Hypothesis:

There will be no difference in outcomes between formal rehabilitation and independent exercises at twelve months after primary total knee replacement surgery using the American Knee Society (AKS) Knee Score.


Condition or disease Intervention/treatment Phase
Recovery Following Primary Total Knee Arthroplasty Procedure: Formal Rehabilitation Therapy Procedure: Independent Exercise Cohort Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Independent Exercise Compared With Formal Rehabilitation Following Primary Total Knee Replacement
Study Start Date : July 2014
Actual Primary Completion Date : October 23, 2015
Actual Study Completion Date : October 23, 2015

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Arm Intervention/treatment
Active Comparator: Formal Rehabilitation Therapy
Patients randomized to the formal rehabilitation therapy cohort will receive a prescription for therapy for twelve weeks following their primary knee replacement.
Procedure: Formal Rehabilitation Therapy
Patients that will be randomized to the formal rehabilitation therapy cohort will be prescribed formal therapy for twelve weeks with supervised exercises to regain knee strength and range of motion. Therapists will not be involved in the study design and therapists will not be informed that patients are participating in this study. The content, frequency, and duration of the rehabilitation program will be at the discretion of the treating therapist, consistent with usual practice.
Other Name: Physical Therapy

Experimental: Independent Exercise Cohort
Patients randomized to the independent exercise cohort will receive online access to a twelve-week protocol of exercises to perform at home to strengthen and improve function of the replaced knee.
Procedure: Independent Exercise Cohort
The patients who will be in the independent exercises cohort will be registered on www.careforpatients.com, an online rehabilitation resource that provides computer aided rehabilitative exercises. Patients will follow a prepared 12-week protocol of exercises to perform post-operatively to gradually regain their knee strength, flexion, extension, abduction, and adduction.




Primary Outcome Measures :
  1. Knee Function [ Time Frame: up to 12 months post-operatively ]
    The American Knee Society Score (AKS) consists of two parts. The first is the Knee Score, which considers pain, stability and range of motion as the main parameters, with deductions for flexion contractures, extension lag and malalignment. The second part, the Function Score, utilizes walking distance and stair climbing as the main parameters with deductions for the use of a walking aid.


Secondary Outcome Measures :
  1. General physical and mental health [ Time Frame: up to 12 months post-operatively ]
    The Short Form 12v2 (SF-12v2) is an abbreviated version of the Short Form-36 (SF-36) that includes the physical and emotional limitations that are placed on work and social activities. The SF-12v2 measures how individuals value their current health state. It has been shown to be reliable (Pearson r > 0.70), valid (highly correlated with SF-36), and responsive for the measurements of health status in many patient populations.

  2. Activity Level [ Time Frame: up to 12 months post-operatively ]
    The UCLA Activity Score assesses an individual's level of activity. The evaluation has ten descriptive activity levels ranging from wholly inactive and dependent on others (level 1), to moderate activities such as unlimited housework and shopping (level 6), to regular participation in impact sports such as jogging or tennis (level 10). The individual is asked to pick the statement that best describes their activity level.

  3. Knee and Osteoarthritis Outcome Score (KOOS) [ Time Frame: up to 12 months post-operatively ]
    The KOOS is a self-administered 40-item questionnaire used to assess patient-relevant outcomes in five separate subscales related to the knee (pain, symptoms, activity of daily living, sport and recreation function and knee related quality of life). The KOOS contains all Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questions in unchanged form, so a WOMAC score can be calculated from the KOOS. The WOMAC is used to assess pain, function, and stiffness of the knee.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for primary total knee arthroplasty
  • an age of eighteen years or older
  • English speaking
  • have a computer with access to the Internet

Exclusion Criteria:

  • any knee arthroplasty other than total knee
  • patients not planning to return for follow up care
  • patients relying on others for basic functioning
  • do not speak English
  • do not have a computer with access to the Internet
  • prior physical therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826305


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Kevin J. Bozic, MD, MBA University of California, San Francisco
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01826305    
Other Study ID Numbers: 12-09642
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020