Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis. Long-term Follow-up.
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Purpose
The purpose of this study is to evaluate the long term effect of exercise therapy and patient education compared to patient education only in individuals with hip OA, and to evaluate predictive factors for changes in hip osteoarthritis both clinically and on x-ray.
Main hypothesis H01: There are no significant long term ( 2 years) differences in hip function, quality of life, physical function and radiological changes between those individuals who went through a patient education program and a 12 week exercise therapy program compared to patient education program only.
Material and Methods:
109 patients with radiographically verified hip OA are included in the randomized controlled trial; randomized to 12 week exercise therapy program and patient education (n=55) and patient education program only (n=54).
Data will be collected 2 years after completed intervention period in the original RCT, and 6 months and 2 years postoperatively for those patients who have undergone total hip arthroplasty.
The main outcome is:
The Disease Specific WOMAC-Index.
Secondary outcome measures are:
Hip X-ray, SF-36v2 (quality of life),PASE (activity score), Self-efficacy for pain, isokinetic muscle strength tests, 6 minute walk test, Åstrand's bike test, range of motion.
Status:
This study is a prolongation of an on-going RCT (3a-2005-NAR). The inclusion, intervention and follow-ups including 1 year follow-up is completed. 2 year post-intervention follow-up will be completed in 2010, 2 year follow-up postoperative for patients undergoing total hip artroplasty will continue throughout 2011.
The study will be carried out: NAR-Orthopedic Centre, Ullevaal University Hospital.
| Condition | Intervention |
|---|---|
|
Hip Osteoarthritis |
Other: A 12 week exercise therapy program and patient education. Other: Patient education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis. Long-term Follow-up of a Prospective, Randomized Controlled Intervention Study. |
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Baseline, 12 weeks, 6, 12 and 24 months. ] [ Designated as safety issue: No ]
- SF-36 (quality of life) [ Time Frame: Baseline, 12 weeks, 6, 12 and 24 months. ] [ Designated as safety issue: No ]
- PASE (activity score) [ Time Frame: Baseline, 12 weeks, 6, 12 and 24 months. ] [ Designated as safety issue: No ]
- Self-efficacy for pain [ Time Frame: Baseline, 12 weeks, 6, 12 and 24 months. ] [ Designated as safety issue: No ]
- Muscle strength tests [ Time Frame: Baseline, 12 weeks, 6 and 24 months. ] [ Designated as safety issue: No ]
- 6 minute walk test [ Time Frame: Baseline, 12 weeks, 6 and 24 months. ] [ Designated as safety issue: No ]
- Åstrand's bike test [ Time Frame: Baseline, 12 weeks, 6 and 24 months. ] [ Designated as safety issue: No ]
- Range of motion [ Time Frame: Baseline, 12 weeks, 6 and 24 months. ] [ Designated as safety issue: No ]
- Radiographic examination [ Time Frame: Baseline and 24 months. ] [ Designated as safety issue: No ]
| Enrollment: | 109 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Other: A 12 week exercise therapy program and patient education.
The exercise protocol includes 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 will be required to exercise for 60 minutes, three days a week for 12 weeks. Patient's attendance to the exercise program (compliance) will be registered by the physical therapists. All patients included in the study will receive two individual and three small-group (6-7 patients) sessions lasting one hour each time. |
| Active Comparator: 2 |
Other: Patient education
All patients included in the study will receive two individual and three small-group (6-7 patients) sessions lasting one hour each time.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Between 40 and 80 years old with uni- or bilateral hip disability
- Harris Hip Score (36) 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 hip surgery (arthroplasty).
- Patients will be included if they have more than 3 months of hip pain.
- Patients with radiographic verified hip OA (Danielson'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 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
Contacts and Locations| Norway | |
| NAR-Orthopedic Centre, Ullevål University Hospital & Hjelp24 NIMI | |
| Oslo, Norway | |
| Principal Investigator: | May Arna Risberg, PT, PhD | NAR- Orthopedic Centre, Ullevål University Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Oslo University Hospital ( Ullevaal University Hospital ) |
| ClinicalTrials.gov Identifier: | NCT01063777 History of Changes |
| Other Study ID Numbers: | 03c-2009-NAR |
| Study First Received: | February 4, 2010 |
| Last Updated: | August 17, 2012 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Oslo University Hospital:
|
Hip Osteoarthritis, Exercise therapy, Patient Education |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Hip Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013