Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis. a RCT.
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|ClinicalTrials.gov Identifier: NCT00319423|
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : February 5, 2010
|First Submitted Date ICMJE||April 27, 2006|
|First Posted Date ICMJE||April 27, 2006|
|Last Update Posted Date||February 5, 2010|
|Study Start Date ICMJE||April 2005|
|Actual Primary Completion Date||February 2009 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 0, 4, 10, 16 months ]|
|Original Primary Outcome Measures ICMJE
||Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)|
|Change History||Complete list of historical versions of study NCT00319423 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis. a RCT.|
|Official Title ICMJE||Evaluation of Function and Effect of Exercise Therapy in Patients With Osteoarthritis of the Hip. A Randomized Controlled Trial.|
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:
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.
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.
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).
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.
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
A randomized controlled trial.
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:
One hundred and ten patients with radiographic verified hip OA will be included in the randomized controlled trial
Interventions It is not considered ethically or practically feasible to use a control group receiving no treatment in this study. Hence, both randomized groups will be offered the patient education intervention, and one of the groups will receive exercise therapy in addition.
Patient Education (KLASSBO M, 2003):
All patients with hip disability with or without verified radiographic OA included in the study will receive two individual and three small-group (6-7 patients) sessions lasting one hour each time.
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.
Pain and Functional Activity:
The primary (main) outcome measurement will be the self-reported functional outcome measure, the disease-specific questionnaire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). WOMAC is found to be a valid, reliable and responsive outcome measure in patients with hip OA.
The self-reported Physical Activity Score for the Elderly (PASE) will be used to record the individuals activity level prior to inclusion and at follow-up intervals. Hip pain will be recorded on a visual analogue scale (VAS) rating from 0 to 100 mm; 0 represents "no pain" and 100 represents "as much pain he/she can possibly imagine". The pain will be recorded after the 6 minutes walking test (se below).
Six minutes walking tests (Enright, 2003): Observed functional capacity and cardiovascular fitness will be assessed by a six minute walk test. This test has been reliability estimated for older adults and validated for older adults and individuals with total hip arthroplasty.
Health related quality of life and pain management: Quality of life will be assessed by using the self-administered generic questionnaire 36-item short-form health survey (SF-36) version 2.
Kinematic data will be collected using Qualisys pro-reflex motion analysis system with eight cameras at a sampling frequency of 240 Hz and synchronized with two force platforms sampling at a rate of 960 Hz (AMTI Model LG6).
Subjects will be instructed to walk along a 17 m walkway in which two force plates are embedded. Speed will be measured by photoelectric beams located 3.06 m apart, midway along the walkway. Eight to ten walking trials will be averaged for each subject. Kinematic and kinetic variables will include hip, knee, and ankle angles and moments, in the sagittal, frontal and transverse planes. The setup and the analysis software that we used are the same as our collaborative group at the University of Delaware use.
Balance(Suni et al. 1998):
Static balance will be tested by one-leg standing. The subject is advised to stand as still as possible and center of pressure will be registered on a force plate (AMTI Model LG6). The test is developed for adults and has been used in several former studies.
Dynamic balance will be registered by the patient performing a two-legged raise from seated position to standing position on the force plate (Mizner &Snyder-Mackler). Center of pressure, kinematic, and kinetic data will be registered.
Muscle strength: Isokinetic muscle strength will be tested in Technogym REV 9000 (Gambettola, Italia) and measured as peak torque at 60°s-1 for hip flexion/extension, knee flexion/extension and ankle flexion/extension. Muscle strength for hip abduction will be conducted isometrically with a dynamometer.
Cardiovascular Fitness (Åstrand & Rodahl, 1986):
will be tested by a sub-maximal bicycle ergometer test according to the method described by Åstrand & Rodahl. The load will be adjusted to each subject. Results will be corrected for age and gender and expressed in ml O2 / kg / min.
Range of motion:
will be registered with a plastic goniometer. Flexion, abduction, and adduction is registered in supine position, with a fixation of the contralateral leg. Internal and external rotation is registered in prone position with fixation over buttocks. Extension is registered according to Thomas test.
Data Collections and Follow-Up In the randomized controlled trial (Aim 1 and 2), data will be collected at inclusion, after the 15 weeks intervention period, and at follow- ups at 6 months, 1 year, and 2 years. Data from all outcome measurements will be collected from all patients at all follow-ups, except for the gait-analysis data (kinematic and kinetic data) (Aim 2). These data will be collected at inclusion and after the intervention period (15 weeks).
The WOMAC Index will be the main outcome measurement in the RCT. Power calculations based on a standard deviation of 23 mm, and a minimum clinically important difference of 15 mm between groups calculated that there is a need for 49 patients in each group. To account for possible drop-outs, 110 patients will be included in the RCT.
Personnel responsible for the intervention will not be involved in data collection. Physical therapists collecting data will be blinded for patients' group allocation. A research coordinate person, not involved in any part of the study intervention or data collections, will be responsible for randomization procedures (give subjects information about group allocation)
Data in the randomized controlled trial will be analyzed both according to the intention to treat principles and additional analysis for the compliers adhering to the exercise protocol at a cut-off value of 24 or more training sessions.
Registration of Complications, Drop-Outs and Compliance:
Complications and drop-outs will be registered by persons responsible for data collection. There will be used intention to treat analysis. Compliance to the patient education and the exercise protocol will be registered by the physical therapists responsible for the treatment.
All patients and control subjects will receive written and oral information about the study and sign an informed consent before inclusion. The project will be performed according to recommendations of the Helsinki Declaration. Approval is obtained from the Regional Committee of Medical Research Ethics.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
|Condition ICMJE||Hip Osteoarthritis|
|Intervention ICMJE||Procedure: Patient education and supervised exercise
Patient education: 3 sessions Supervised exercise: 2-3 times/week for 12 weeks
|Study Arms ICMJE||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE||Same as current|
|Study Completion Date ICMJE||Not Provided|
|Actual Primary Completion Date||February 2009 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages ICMJE||40 Years to 80 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Norway|
|Removed Location Countries|
|NCT Number ICMJE||NCT00319423|
|Other Study ID Numbers ICMJE||03a-2005-NAR|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Ullevaal University Hospital|
|Collaborators ICMJE||Norwegian Foundation for Health and Rehabilitation|
|PRS Account||Ullevaal University Hospital|
|Verification Date||April 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP