Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis. a RCT.
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

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:

      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.
    

Detailed description: 
      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 and 95 is used as
           inclusion criteria for the present study population.

        -  All subjects will have x-ray taken. Those with radiographic verified hip OA will be
           classifies by an orthopaedic surgeon (LN) according to Danielsson's criteria for
           radiographic hip OA (34).

      One hundred and ten patients with radiographic verified hip OA will be included in the
      randomized controlled trial

      Exclusion Criteria

        -  Patients will be excluded if they 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 will be excluded.

      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.

      Exercise Protocol:

      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.

      Outcome Measurements

      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.

      Hip Biomechanics:

      Gait analysis:

      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).

      Power Calculations:

      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.

      Blinding:

      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)

      Statistical Analysis:

      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.

      Ethics:

      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.
    

Intervention name(s): Patient education and supervised exercise
Intervention type(s): Procedure
Intervention description(s): Patient education: 3 sessions Supervised exercise: 2-3 times/week for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Hip Osteoarthritis, Exercise therapy, Patient Education