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:
- 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
- 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:
- Patient Education, or
- 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