Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis. a RCT.

This study has been completed.
Sponsor:
Collaborator:
Norwegian Foundation for Health and Rehabilitation
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00319423
First received: April 27, 2006
Last updated: February 4, 2010
Last verified: April 2006
  Purpose

Aims:

  1. Evaluate the effect of an exercise therapy program and patient education, versus patient education only, on hip function among patients with radiologically verified hip OA
  2. To identify biomechanical differences during gait, one-leg standing , and two-legged-raise analysis in patients with hip OA following either exercise therapy and patient education program, or a patient education program only.

Main Hypothesis:

Significant improved hip function (WOMAC) will be demonstrated in patients with hip osteoarthritis (OA) (radiographically verified hip OA) following a patient education program and a 12 week exercise therapy program, compared to those only going through a patient education program.

Material and Methods:

110 patients with radiographically verified hip OA will be included in the randomized controlled trial; they will be randomized into:

  1. Patient Education, or
  2. Patient Education in addition to a supervised exercise program.

The main outcome is:

The Disease Specific WOMAC-Index.

Secondary outcome measures are:

SF-36v2 (quality of life),PASE (activity score), Self-efficacy for pain, muscle strength tests, gait analysis (biomechanical analysis),6 minutes walking test, Åstrand's bike test, range of motion.

Status:

The PhD student is accepted at the University of Oslo,and the study has so far included 17 subjects.

The study will be carried out:

NAR-Orthopedic Centre, Ullevaal University Hospital in collaboration with Diakonhjemmet Hospital and University of Delaware.

The study is included in our research program for active rehabilitation.


Condition Intervention
Hip Osteoarthritis
Procedure: Patient education and supervised exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Function and Effect of Exercise Therapy in Patients With Osteoarthritis of the Hip. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 0, 4, 10, 16 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-36 (quality of life) [ Time Frame: 0, 4, 10, 16 months ] [ Designated as safety issue: No ]
  • PASE (activity score) [ Time Frame: 0, 4, 10, 16 months ] [ Designated as safety issue: No ]
  • Self-efficacy for pain [ Time Frame: 0, 4, 10, 16 months ] [ Designated as safety issue: No ]
  • Muscle strength tests [ Time Frame: 0, 4, 10 months ] [ Designated as safety issue: No ]
  • Gait analysis (biomechanical analysis) [ Time Frame: 0, 4 months ] [ Designated as safety issue: No ]
  • 6 minute walk test [ Time Frame: 0, 4, 10 months ] [ Designated as safety issue: No ]
  • Åstrand's bike test [ Time Frame: 0, 4, 10 months ] [ Designated as safety issue: No ]
  • Range of motion [ Time Frame: 0, 4, 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: April 2005
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Patient education
Patient education according to Klassbo et al 2003
Procedure: Patient education and supervised exercise
Patient education: 3 sessions Supervised exercise: 2-3 times/week for 12 weeks
Experimental: Patient education and supervised exercise
Patient education according to Klassbo et al 2003. Supervised exercise containing strengthening, functional and flexibility exercises.
Procedure: Patient education and supervised exercise
Patient education: 3 sessions Supervised exercise: 2-3 times/week for 12 weeks

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319423

Locations
Norway
NAR-Orthopedic Centre, Ullevål University Hospital & NIMI
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Norwegian Foundation for Health and Rehabilitation
Investigators
Principal Investigator: May Arna Risberg, PT, PhD NAR- Orthopedic Centre, Ullevål University Hospital
  More Information

No publications provided by Ullevaal University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00319423     History of Changes
Other Study ID Numbers: 03a-2005-NAR
Study First Received: April 27, 2006
Last Updated: February 4, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Ullevaal 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 August 21, 2014