Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis of the Hip. A Case-Control Study

This study has been completed.
Sponsor:
Collaborator:
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
May Arna Risberg, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00319124
First received: April 27, 2006
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

To identify differences between patients with OA of the hip in an early stage and a healthy control group.

Hypothesis 1.1 There are significant differences between patients with OA of the hip in an early stage and a healthy control group in terms of functional capacity, biomechanical / kinematic variables, muscle strength and range of motion.

Osteoarthritis (OA) is by far the most prevalent joint disorder today. The knee and the hip are large joints to be targeted and is an important cause of pain and disability. In knee OA, it is shown that significant risk factors in developing the disease are quadriceps weakness, joint instability, and changes in joint loading. A few studies on hip OA have shown altered gait pattern, which affect joint loading, and one study has shown weakness in abductors, adductors and flexors around the hip. As joint loading and muscle weakness are important factors in the development in knee OA, it might as well be factors influencing OA in the hip. The purpose of this case-control studies was to compare hip OA patients to a healthy control group regarding biomechanical and clinical differences. Patients with hip pain, activity limitations (Harris Hip Score 60-95 p) and radiographically verified hip OA was included. The healthy control group will have a Harris Hip Score of 100 p. One hundred and ten patients and fifty controls will be asked to fill in questionnaires on pain, stiffness and physical function (WOMAC), quality-of-life (SF-36 v2), self-efficacy (Lorigue), and activity (PASE) in addition to perform 6-minute walk test, sub-maximal cardiovascular function, strength, and hip range of motion tests. Additionally, Qualisys Pro reflex 3D motion analysis system will be used during walking, one-leg standing, and raising from a chair on a sub-group of 40 patients and 20 controls.


Condition
Hip Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Function and Effect of Exercise in Patients With Osteoarthritis of the Hip.A Case-control 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-36 (quality of life) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • PASE (activity score) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • muscle strength tests (Cybex 6000) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • gait analysis (biomechanical analysis) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • 6 minutes walking test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Åstrand's bike test [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Range of Motion (goniometer) [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: April 2005
Study Completion Date: October 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case
Patients with hip Osteoarthritis
Control
Healthy controls without hip osteoarthritis

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with hip osteoarthritis and mild to moderate pain. Matched controls with no hip pain.

Criteria

Inclusion Criteria for patients with hip OA:

  • 110 patients 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).
  • Fifty control subjects will have no health problems and no injuries or functional impairment to the lower limbs and will be matched to the patients with OA of the hip by age and gender.

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: NCT00319124

Locations
Norway
NAR- Department of Orthopaedics, Oslo University Hospital & Hjelp24NIMI
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Norwegian Foundation for Health and Rehabilitation
Investigators
Principal Investigator: May Arna Risberg, PT,PhD NAR-Department of Orthopaedics, Oslo University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: May Arna Risberg, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00319124     History of Changes
Other Study ID Numbers: 03b-2005-NAR
Study First Received: April 27, 2006
Last Updated: May 22, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Hip Osteoarthritis, muscle strength, range of motion, aerobic capacity, functional capacity, health-related quality of life

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

ClinicalTrials.gov processed this record on July 28, 2014