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Time to Total Hip Replacement After Supervised Exercise and Patient Education

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ClinicalTrials.gov Identifier: NCT01338532
Recruitment Status : Unknown
Verified August 2012 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 19, 2011
Last Update Posted : August 20, 2012
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital

Brief Summary:

The purpose of this study is to evaluate the time to total hip replacement in patients with hip osteoarthritis going through both a supervised exercise program and patient education compared to patients going through patient education only.

The null hypothesis is: There are no differences in time to total hip replacement between patients with hip osteoarthritis who went through a 12 week supervised exercise program and patient education compared to patients who went through patient education only.

Material and methods:

109 patients with both symptomatically and radiographically verified hip osteoarthritis were included in this randomized controlled trial between april 2005 and october 2007. They were randomized to either a 12 week supervised exercise program and patient education (n=55) or patient education only (n=54).

Information on if and when total hip replacement is performed will be collected between April 1st and May 1st. Time since inclusion to follow-up will range from 3.5 to 6 years. Data will be collected directly from the study participants by telephone.

The main outcome is time to total hip replacement.

Status:

This study is a prolongation of an on-going RCT (3a-2005-NAR) using clinical outcomes to evaluate the effect of supervised exercise and patient education.

The study will be carried out: NAR-Department of Orthopedics, Ullevaal University Hospital.


Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Other: A 12 week supervised exercise program and patient education Other: Patient education Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Time to Total Hip Replacement in Patients With Hip Osteoarthritis Going Through Both Supervised Exercise and Patient Education Compared to Those Going Through Patient Education Only. A 3.5-6 Year Follow-up of a Randomized, Controlled, Clinical Trial.
Study Start Date : March 2005
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Supervised exercise + patient education Other: A 12 week supervised exercise program and patient education

The exercise protocol included exercises from former studies on comparable patient populations. The intensity of the strength- and flexibility exercises meets the American College of Sports Medicine's (ACSM) recommendations for developing and maintaining muscular fitness in adults. Patients was required to exercise for approximately 60 minutes, to-three days a week for 12 weeks. Patient's attendance to the exercise program (compliance) was registered.

All patients included in the study participated in a patient education program which included two individual and three small-group sessions lasting one hour each time.

Active Comparator: Patient education Other: Patient education
All patients included in the study participated in a patient education program which included two individual and three small-group sessions lasting one hour each time.



Primary Outcome Measures :
  1. Time to Total Hip Replacement surgery (THR) [ Time Frame: 3.5 to 6 years after inclusion ]
    All included patients will be examined regarding if they have gone through THR surgery since their inclusion in the present study. For those who report to have gone through THR surgery, date for when surgery were performed will be collected.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 40 and 80 years old with uni- or bilateral hip disability.
  • Hip pain for more then 3 months.
  • Harris Hip Score between 60 and 95. Harris Hip score (0-100 points) is widely used as an assessment of hip function in patients with hip OA. Harris Hip Score of 60 or below are used regularly at our institution as one of the criteria for total hip replacement surgery.
  • Radiographic verified hip OA (Danielsson's criteria for radiographic OA: Danielsson's criteria for minimal joint space: < 4 mm < 70 years, < 3 mm ≥ 70 years, or 1 mm difference between hips).

Exclusion Criteria:

  • Patients who have a history of resent trauma or functional impairment to the lower limbs or diseases which might interfere with participation (rheumatoid arthritis, cancer, osteoporosis, severe back pain, knee OA).
  • Patients with co-morbidities not tolerating physical activities

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): NCT01338532


Locations
Norway
NAR-Orthopedic Department, Oslo University Hospital & Hjelp24 NIMI
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: May Arna Risberg, PT, PhD NAR- Department of Orthopedics, Oslo University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01338532     History of Changes
Other Study ID Numbers: 03c-2011-NAR
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: August 20, 2012
Last Verified: August 2012

Keywords provided by Oslo University Hospital:
Hip osteoarthritis
Exercise
Patient Education
Total Hip Replacement

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases