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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Function and Effect of Exercise Therapy in Patients With Osteoarthritis of the Hip. A Randomized Controlled Trial.

Brief Summary:

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:

Detailed Summary:

Aim 1:

To evaluate the effect of an exercise therapy program for 12 weeks and a patient education program compared to a patient education program only on hip function (WOMAC) in patients with hip osteoarthritis (OA) (radiographically verified hip OA, Harris Hip Score 60-95p, and >3 months of hip pain).

Aim 2:

To identify biomechanical differences during gait 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 following a patients education program with an additionally 12 week exercise therapy program, compared to those only going through a patient education program.

MATERIAL AND METHODS

Design:

A randomized controlled trial.

Inclusion Criteria:

Patients between 40 and 80 years old with uni- or bilateral hip disability not eligible for hip surgery will be recruited from Orthopaedic Centre, Ullevål University Hospital, NIMI, and Diakonhjemmets Sykehus (Hospital), Oslo. Inclusion criteria for all subjects are:

  • Harris Hip Score (35) between 60 and 95, and hip pain of more than 3 months. Harris Hip Score (35) of 60 or below are used regularly at our institution as one of the criteria for hip surgery (arthroplasty), therefore Harris Hip Score between 60
    Sponsor: Ullevaal University Hospital

    Current Primary Outcome: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 0, 4, 10, 16 months ]

    Original Primary Outcome: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Current Secondary Outcome:

    • SF-36 (quality of life) [ Time Frame: 0, 4, 10, 16 months ]
    • PASE (activity score) [ Time Frame: 0, 4, 10, 16 months ]
    • Self-efficacy for pain [ Time Frame: 0, 4, 10, 16 months ]
    • Muscle strength tests [ Time Frame: 0, 4, 10 months ]
    • Gait analysis (biomechanical analysis) [ Time Frame: 0, 4 months ]
    • 6 minute walk test [ Time Frame: 0, 4, 10 months ]
    • Åstrand's bike test [ Time Frame: 0, 4, 10 months ]
    • Range of motion [ Time Frame: 0, 4, 10 months ]


    Original Secondary Outcome:

    • SF-36 (quality of life)
    • PASE (activity score)
    • Self-efficacy for pain
    • Muscle strength tests
    • Gait analysis (biomechanical analysis)
    • 6 minute walk test
    • Åstrand's bike test
    • Range of motion


    Information By: Ullevaal University Hospital

    Dates:
    Date Received: April 27, 2006
    Date Started: April 2005
    Date Completion:
    Last Updated: February 4, 2010
    Last Verified: April 2006