Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319423
Status:
COMPLETED
Last Update Posted:
2010-02-05
First Post:
2006-04-27
Brief Title:
Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis a RCT
Sponsor:
Ullevaal University Hospital
Organization:
Ullevaal University Hospital
Study Overview
Official Title:
Evaluation of Function and Effect of Exercise Therapy in Patients With Osteoarthritis of the Hip A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 lifePASE activity score Self-efficacy for pain muscle strength tests gait analysis biomechanical analysis6 minutes walking test Åstrands bike test range of motion
Status
The PhD student is accepted at the University of Osloand 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
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 lifePASE activity score Self-efficacy for pain muscle strength tests gait analysis biomechanical analysis6 minutes walking test Åstrands bike test range of motion
Status
The PhD student is accepted at the University of Osloand 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 Danielssons 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 Medicines ACSM recommendations for developing and maintaining muscular fitness in adultsPatients will be required to exercise for 60 minutes three days a week for 12 weeks Patients 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 heshe 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 306 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
BalanceSuni 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 60s-1 for hip flexionextension knee flexionextension and ankle flexionextension 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
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 Danielssons 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 Medicines ACSM recommendations for developing and maintaining muscular fitness in adultsPatients will be required to exercise for 60 minutes three days a week for 12 weeks Patients 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 heshe 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 306 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
BalanceSuni 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 60s-1 for hip flexionextension knee flexionextension and ankle flexionextension 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None