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Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty

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: NCT01877733
Recruitment Status : Completed
First Posted : June 14, 2013
Last Update Posted : September 19, 2017
Sponsor:
Collaborators:
St. Olavs Hospital
Central Norway Regional Health Authority
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:

The purpose of this study is to investigate the effect of maximal strength training (MST) compared to standard rehabilitation in patients operated with total knee arthroplasty. Previous studies report reduced physical function and muscle strength despite successful surgery inserting an artificial implant.

Furthermore, great loss of muscle strength has been found in these patients in the early postoperative phase.

The study is a randomized controlled trial. The investigators hypothesize that MST will increase muscle strength and physical function more than standard rehabilitation.


Condition or disease Intervention/treatment Phase
Osteoarthritis Other: Maximal strength training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effective Rehabilitation of Patients Operated With Total Knee Arthroplasty
Actual Study Start Date : January 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Maximal strenght training
Training maximal strength training 3 times a week/1 physiotherapy session for 8 weeks
Other: Maximal strength training
No Intervention: Standard rehabilitation
2-3 physiotherapy sessions a week for 8 weeks/telephone contact by project leader once a week/writing training diary



Primary Outcome Measures :
  1. Muscle strength in leg extension and leg press [ Time Frame: Measured preoperatively, after 7 days, 10 wks and 1 year ]
    Measured preoperatively implies measuring the outcome within the last month prior to surgery


Secondary Outcome Measures :
  1. 6 minute walk test [ Time Frame: preopertively, 7 days postoperatively and after 1 year ]
    Measuring the outcome preoperatively implies testing within the last month prior to surgery

  2. KOOS; Knee injury and osteosarthritis outcome score [ Time Frame: Preoperatively (within 1 month prior to surgery), 7 days postoperatively and 10 wks and 1 year postoperatively ]
  3. EQ-5D (measure of health outcome) [ Time Frame: Preoperatively (within 1 month prior to surgery), 7 days, 10 wks and 1 year postoperatively ]
  4. VAS scale recording pain [ Time Frame: preoperatively (within 1 month prior to surgery), 7 days, 10 wks and 1 year postoperatively ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unilateral osteoarthritis,
  • < 75 years

Exclusion Criteria:

  • disease(s) that compromise testing/training,
  • unable to understand written and verbal instructions and information,
  • osteoarthritis in the contralateral leg that needs treatment.

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): NCT01877733


Locations
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Norway
St. Olavs hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Central Norway Regional Health Authority
Investigators
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Principal Investigator: Vigdis S Husby, PhD Norwegian University of Science and Technology

Publications of Results:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01877733     History of Changes
Other Study ID Numbers: 2012/1678
First Posted: June 14, 2013    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Resistance training
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases