Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319124
Status:
COMPLETED
Last Update Posted:
2016-03-02
First Post:
2006-04-27
Brief Title:
Exercise Therapy and Patient Education for Individuals With Hip Osteoarthritis of the Hip A Case-Control Study
Sponsor:
Ullevaal University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Evaluation of Function and Effect of Exercise in Patients With Osteoarthritis of the HipA Case-control Study
Status:
COMPLETED
Status Verified Date:
2012-05
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:
To identify differences between patients with OA of the hip in an early stage and a healthy control group
Hypothesis 11 There are significant differences between patients with OA of the hip in an early stage and a healthy control group in terms of functional capacity biomechanical kinematic variables muscle strength and range of motion
Osteoarthritis OA is by far the most prevalent joint disorder today The knee and the hip are large joints to be targeted and is an important cause of pain and disability In knee OA it is shown that significant risk factors in developing the disease are quadriceps weakness joint instability and changes in joint loading A few studies on hip OA have shown altered gait pattern which affect joint loading and one study has shown weakness in abductors adductors and flexors around the hip As joint loading and muscle weakness are important factors in the development in knee OA it might as well be factors influencing OA in the hip The purpose of this case-control studies was to compare hip OA patients to a healthy control group regarding biomechanical and clinical differences Patients with hip pain activity limitations Harris Hip Score 60-95 p and radiographically verified hip OA was included The healthy control group will have a Harris Hip Score of 100 p One hundred and ten patients and fifty controls will be asked to fill in questionnaires on pain stiffness and physical function WOMAC quality-of-life SF-36 v2 self-efficacy Lorigue and activity PASE in addition to perform 6-minute walk test sub-maximal cardiovascular function strength and hip range of motion tests Additionally Qualisys Pro reflex 3D motion analysis system will be used during walking one-leg standing and raising from a chair on a sub-group of 40 patients and 20 controls
Hypothesis 11 There are significant differences between patients with OA of the hip in an early stage and a healthy control group in terms of functional capacity biomechanical kinematic variables muscle strength and range of motion
Osteoarthritis OA is by far the most prevalent joint disorder today The knee and the hip are large joints to be targeted and is an important cause of pain and disability In knee OA it is shown that significant risk factors in developing the disease are quadriceps weakness joint instability and changes in joint loading A few studies on hip OA have shown altered gait pattern which affect joint loading and one study has shown weakness in abductors adductors and flexors around the hip As joint loading and muscle weakness are important factors in the development in knee OA it might as well be factors influencing OA in the hip The purpose of this case-control studies was to compare hip OA patients to a healthy control group regarding biomechanical and clinical differences Patients with hip pain activity limitations Harris Hip Score 60-95 p and radiographically verified hip OA was included The healthy control group will have a Harris Hip Score of 100 p One hundred and ten patients and fifty controls will be asked to fill in questionnaires on pain stiffness and physical function WOMAC quality-of-life SF-36 v2 self-efficacy Lorigue and activity PASE in addition to perform 6-minute walk test sub-maximal cardiovascular function strength and hip range of motion tests Additionally Qualisys Pro reflex 3D motion analysis system will be used during walking one-leg standing and raising from a chair on a sub-group of 40 patients and 20 controls
Detailed Description:
Aim 1 To identify differences between patients with OA of the hip in an early stage and a healthy control group
Hypothesis 11 There are significant differences between patients with OA of the hip in an early stage and a healthy control group in terms of functional capacity biomechanical kinematic variables muscle strength and range of motion
Material and methods
Design A case-control study
Inclusion exclusion criteria Twenty-five patients diagnosed with unilateral or bilateral OA of the hip will be recruited from the Norwegian Sport Medicine Centre Diakonhjemmet and from the Orthopaedic Centre Ullevål University Hospital Oslo Norway PPatients will also be recruited through ads in newspaper and brief information in national tv Radiographiccally verified OA of the hip will be in accordance with Danielssons criteria for minimal joint space 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
Control subjects will have no health problems and no injuries or functional impairment to the lower limbs and will be matched to the patients with OA of the hip by age and gender
Outcome measures
Background descriptive data including anthropometrical age gender height weight and sociodemographic information marital status social support leisure time sick-leave physical activity occupational background co-morbidity hip pain history former treatment for hip pain OA and consumption of analgetics will be collected by questionnaire at inclusion Outcome measures will cover all functional levels defined by the World Health Organizations WHO International Classification of Functioning Disability and Health 2002 and will include
Pain and activity limitation Hip pain will be assessed by a horizontal visual analogue scale VAS 0-100 mm 0 represents no pain and 100 represents as much pain heshe can possibly imagine Revill et al 1976 Both self-reported and observed functional capacity will be evaluated Self-reported functional capacity will be registered by the disease-specific questionnaire Western Ontario and McMaster Universities Osteoarthritis Index WOMAC Bellamy et al 1988 Observed functional capacity will be assessed by the 6 minute walking test Enright 2003 where the patient is instructed to walk as quicklyfast as possible forth and back on a 20 m course and by the subaximal bikecycle test Astrand 1986 where the heart-rate is registered on a constant load and speed
Health related quality of life and pain management Quality of life will be assessed by using the generic questionnaire SF-36 v2 Jenkinson 1999 Self-efficacy beliefs for pain will be registered using the self-efficacy subscale for controlling pain developed by Lorig et al Lorig et al 1989 The scale is found to be valid and reproducible in patients with chronic arthritis Lorig et al 1989
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 960Hz AMTI Model LG6 All markers will be present during standing calibration During the dynamic trials all the anatomical markers will be removed
Subjects will be instructed to walk along a 17m walkway in which two force plates are embedded The subjects will walk at their self-selected pace and practice trials will be performed until the subject could contact the force platforms with only one foot not targeting and with a constant velocity within 5 deviation Speed will be measured by photoelectric beams located 306m apart midway along the walkway Experienced physical therapists will be responsible for patient information instruction and data collection
Muscle strength Muscle strength of hip extensors -flexors knee flexors and -extensors and ankle flexors and extensors in addition to ankle plantar flexion will be tested isokinetically according to the manufacturers manual Cybex 6000 Isokinetic muscle testing is commonly used in the literature in various patient populations Inkster et al 2003 Holm et al 2000b Brox et al 1995 Lephart et al 1993 Newton et al 1993 The test protocol will consist of five repetitions at an angular velocity of 60 degsec at maximal performance In order to prepare patients for the test eliminate learning effects and to obtain stable performance patients will be given four test-repetitions at the same speed before the main test An experienced physical therapist will perform the test
Range of motion Range of motion will be measured by goniometer according to standard procedures Holm et al 2000a
Follow up Data will be collected at inclusion patients and control subjects and after the intervention period patients
Blinding Personnel responsible for the intervention will not be involved in data collection
Registration of complications drop-outs and adherence Complications and drop-outs will be registered by persons responsible for data collection Adherence to the exercise protocol will be registered by the physical therapists responsible for the treatment
Power calculations Lack of information from studies of comparable OA populations in the literature makes it difficult to make precise power calculations Assumption of sample size 110 patients and 50 control subjects is therefore based on results from former studies in patients with OA of the knee or mixed populations of knee- and hip patients
Statistical analysis Both non-parametric and parametric statistics will be used for data analysis
Ethics All patients and control subjects will receive written and oral information about the study and sign an informed consent before inclusion enclosed The project will be performed according to recommendations of the Helsinki Declaration and application will be sent to the Regional Committee of Medical Research Ethics in Oslo in November 2003
Hypothesis 11 There are significant differences between patients with OA of the hip in an early stage and a healthy control group in terms of functional capacity biomechanical kinematic variables muscle strength and range of motion
Material and methods
Design A case-control study
Inclusion exclusion criteria Twenty-five patients diagnosed with unilateral or bilateral OA of the hip will be recruited from the Norwegian Sport Medicine Centre Diakonhjemmet and from the Orthopaedic Centre Ullevål University Hospital Oslo Norway PPatients will also be recruited through ads in newspaper and brief information in national tv Radiographiccally verified OA of the hip will be in accordance with Danielssons criteria for minimal joint space 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
Control subjects will have no health problems and no injuries or functional impairment to the lower limbs and will be matched to the patients with OA of the hip by age and gender
Outcome measures
Background descriptive data including anthropometrical age gender height weight and sociodemographic information marital status social support leisure time sick-leave physical activity occupational background co-morbidity hip pain history former treatment for hip pain OA and consumption of analgetics will be collected by questionnaire at inclusion Outcome measures will cover all functional levels defined by the World Health Organizations WHO International Classification of Functioning Disability and Health 2002 and will include
Pain and activity limitation Hip pain will be assessed by a horizontal visual analogue scale VAS 0-100 mm 0 represents no pain and 100 represents as much pain heshe can possibly imagine Revill et al 1976 Both self-reported and observed functional capacity will be evaluated Self-reported functional capacity will be registered by the disease-specific questionnaire Western Ontario and McMaster Universities Osteoarthritis Index WOMAC Bellamy et al 1988 Observed functional capacity will be assessed by the 6 minute walking test Enright 2003 where the patient is instructed to walk as quicklyfast as possible forth and back on a 20 m course and by the subaximal bikecycle test Astrand 1986 where the heart-rate is registered on a constant load and speed
Health related quality of life and pain management Quality of life will be assessed by using the generic questionnaire SF-36 v2 Jenkinson 1999 Self-efficacy beliefs for pain will be registered using the self-efficacy subscale for controlling pain developed by Lorig et al Lorig et al 1989 The scale is found to be valid and reproducible in patients with chronic arthritis Lorig et al 1989
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 960Hz AMTI Model LG6 All markers will be present during standing calibration During the dynamic trials all the anatomical markers will be removed
Subjects will be instructed to walk along a 17m walkway in which two force plates are embedded The subjects will walk at their self-selected pace and practice trials will be performed until the subject could contact the force platforms with only one foot not targeting and with a constant velocity within 5 deviation Speed will be measured by photoelectric beams located 306m apart midway along the walkway Experienced physical therapists will be responsible for patient information instruction and data collection
Muscle strength Muscle strength of hip extensors -flexors knee flexors and -extensors and ankle flexors and extensors in addition to ankle plantar flexion will be tested isokinetically according to the manufacturers manual Cybex 6000 Isokinetic muscle testing is commonly used in the literature in various patient populations Inkster et al 2003 Holm et al 2000b Brox et al 1995 Lephart et al 1993 Newton et al 1993 The test protocol will consist of five repetitions at an angular velocity of 60 degsec at maximal performance In order to prepare patients for the test eliminate learning effects and to obtain stable performance patients will be given four test-repetitions at the same speed before the main test An experienced physical therapist will perform the test
Range of motion Range of motion will be measured by goniometer according to standard procedures Holm et al 2000a
Follow up Data will be collected at inclusion patients and control subjects and after the intervention period patients
Blinding Personnel responsible for the intervention will not be involved in data collection
Registration of complications drop-outs and adherence Complications and drop-outs will be registered by persons responsible for data collection Adherence to the exercise protocol will be registered by the physical therapists responsible for the treatment
Power calculations Lack of information from studies of comparable OA populations in the literature makes it difficult to make precise power calculations Assumption of sample size 110 patients and 50 control subjects is therefore based on results from former studies in patients with OA of the knee or mixed populations of knee- and hip patients
Statistical analysis Both non-parametric and parametric statistics will be used for data analysis
Ethics All patients and control subjects will receive written and oral information about the study and sign an informed consent before inclusion enclosed The project will be performed according to recommendations of the Helsinki Declaration and application will be sent to the Regional Committee of Medical Research Ethics in Oslo in November 2003
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