Time to Total Hip Replacement After Supervised Exercise and Patient Education
Primary Purpose
Hip Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
A 12 week supervised exercise program and patient education
Patient education
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Hip osteoarthritis, Exercise, Patient Education, Total Hip Replacement
Eligibility 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
Sites / Locations
- NAR-Orthopedic Department, Oslo University Hospital & Hjelp24 NIMI
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Supervised exercise + patient education
Patient education
Arm Description
Outcomes
Primary Outcome Measures
Time to Total Hip Replacement surgery (THR)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01338532
First Posted
April 18, 2011
Last Updated
August 17, 2012
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01338532
Brief Title
Time to Total Hip Replacement After Supervised Exercise and Patient Education
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 Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
Hip osteoarthritis, Exercise, Patient Education, Total Hip Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supervised exercise + patient education
Arm Type
Active Comparator
Arm Title
Patient education
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
A 12 week supervised exercise program and patient education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Patient education
Intervention Description
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 Measure Information:
Title
Time to Total Hip Replacement surgery (THR)
Description
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.
Time Frame
3.5 to 6 years after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
May Arna Risberg, PT, PhD
Organizational Affiliation
NAR- Department of Orthopedics, Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
NAR-Orthopedic Department, Oslo University Hospital & Hjelp24 NIMI
City
Oslo
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
24255546
Citation
Svege I, Nordsletten L, Fernandes L, Risberg MA. Exercise therapy may postpone total hip replacement surgery in patients with hip osteoarthritis: a long-term follow-up of a randomised trial. Ann Rheum Dis. 2015 Jan;74(1):164-9. doi: 10.1136/annrheumdis-2013-203628. Epub 2013 Nov 19.
Results Reference
derived
Links:
URL
http://www.active-rehab.no
Description
Homepage NAR
Learn more about this trial
Time to Total Hip Replacement After Supervised Exercise and Patient Education
We'll reach out to this number within 24 hrs