Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis. Long-term Follow-up.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital ( Ullevaal University Hospital )
ClinicalTrials.gov Identifier:
NCT01063777
First received: February 4, 2010
Last updated: August 17, 2012
Last verified: August 2012
  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.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Baseline, 12 weeks, 6, 12 and 24 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063777

Locations
Norway
NAR-Orthopedic Centre, Ullevål University Hospital & Hjelp24 NIMI
Oslo, Norway
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
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 April 23, 2014