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Trial registered on ANZCTR
Registration number
ACTRN12621000489897
Ethics application status
Approved
Date submitted
27/11/2019
Date registered
27/04/2021
Date last updated
27/04/2021
Date data sharing statement initially provided
27/04/2021
Date results information initially provided
27/04/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of a 12 month physiotherapy program on hip joint structure and function in patients with hip osteoarthritis
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Scientific title
The effect of a 12 month physiotherapy program on hip joint structure and function in patients with hip osteoarthritis
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Secondary ID [1]
299154
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis
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Hip joint function
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Condition category
Condition code
Physical Medicine / Rehabilitation
312580
312580
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0
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Physiotherapy
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Musculoskeletal
312581
312581
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0
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention studied is a long-term physiotherapy program.
The intervention is delivered by physiotherapist with minimum 5 years’ experience.
The intervention is provided individually and all treatment sessions are therapist-supervised.
The duration of the whole intervention is 12 months. The intervention is delivered in three 3-weeks cycles consisting of 5 therapeutic sessions per week. Each session lasts 140 minutes. The first and second cycle are followed by a 5-month interval.
The exercise session consists of hip joint traction followed by hip suspension exercises, lower extremities muscle strengthening and proprioception training.
Additionally, before each session, transcutaneous electrical nerve stimulation (TENS) is administered for 30 minutes. Electrical stimulation is delivered using two disposable, 60 x 60 mm, carbon electrodes. TENS setting is in a conventional mode, emitting a pulsed biphasic, symmetrical rectangular wave with a frequency of 100 Hz and a pulse duration of 100 µs. The intensity is set according to the participant’s tolerance then gradually increased and limited by the perception of strong but comfortable tingling.
The intervention occurs at the rehabilitation outpatient clinic.
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Intervention code [1]
315428
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Treatment: Other
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Intervention code [2]
315429
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Rehabilitation
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary outcome for the study is hip-related functional evaluation performed using Hip dysfunction and Osteoarthritis Outcome Score (HOOS).
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Assessment method [1]
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Timepoint [1]
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The self-reported questionnaire assessment is performed four times, at the baseline and after each cycle of physiotherapy.
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Primary outcome [2]
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Another primary outcome for the study is hip-related functional evaluation performed using The Osteoarthritis Research Society International core set of performance-based tests of physical function for use in people with hip and knee osteoarthritis (30-second Chair Stand Test (30s CST), 40-m Fast-paced Walk Test (40m FPWT) and Stair Climb Test (SCT)). This is a composite primary outcome.
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Assessment method [2]
324280
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Timepoint [2]
324280
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The assessor-observed performance-based tests evaluation is performed four times, at the baseline and after each cycle of physiotherapy.
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Secondary outcome [1]
374417
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The secondary outcome for the study is magnetic resonance assessment of the hip joint. Parameters are analyzed using Scoring Hip Osteoarthritis with MRI (SHOMRI) evaluation system.
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Assessment method [1]
374417
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Timepoint [1]
374417
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The MRI measurement is performed twice, at the baseline and after the 12-month intervention.
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Eligibility
Key inclusion criteria
Patients with hip osteoarthritis fulfilling American College of Rheumatology (ACR) classification criteria.
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Minimum age
40
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Contraindications for MRI imaging, physiotherapeutic treatment or physical activity; systemic arthritic conditions or diseases that could significantly affect the condition of the hip joint and the patient's functional capabilities; prior hip surgery or lower extremity joint replacement; intra-articular corticosteroid injection or oral steroid or NSAID chronic use within six months; viscosupplementation within six months; prior cerebral vascular accident or other neurological disorders affected sensorimotor functions; history of myocardial infarction; history of cancer; general poor health status;
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
7/03/2016
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Date of last participant enrolment
Anticipated
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Actual
26/02/2018
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Date of last data collection
Anticipated
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Actual
20/03/2019
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Sample size
Target
50
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Accrual to date
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Final
37
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Recruitment outside Australia
Country [1]
21826
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Poland
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State/province [1]
21826
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Medical University of Warsaw
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Address [1]
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2nd Department of Clinical Radiology Medical University of Warsaw
1a Stefana Banacha St., 02-097 Warsaw, Poland
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Country [1]
303695
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Poland
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Primary sponsor type
Individual
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Name
Andrzej Cieszanowski
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Address
2nd Department of Clinical Radiology, Medical University of Warsaw
1a Stefana Banacha St., 02-097 Warsaw, Poland
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Country
Poland
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Secondary sponsor category [1]
304642
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Individual
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Name [1]
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Piotr Palczewski
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Address [1]
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1st Department of Clinical Radiology, Medical University of Warsaw
5 Chalubinskiego St., 02-004 Warsaw, Poland
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Country [1]
304642
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Poland
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304219
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Committee on Bioethics of the Medical University of Warsaw
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Ethics committee address [1]
304219
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61 Zwirki i Wigury St., 02-091 Warsaw, Poland
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Ethics committee country [1]
304219
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Poland
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Date submitted for ethics approval [1]
304219
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Approval date [1]
304219
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07/10/2014
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Ethics approval number [1]
304219
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KB/189/2014
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Summary
Brief summary
The main purpose of the study is to investigate the effect a long term exercise program has on the hip joint structure and function in patients with hip osteoarthritis completing long-term land-based physiotherapy program. In addition the study aims to investigates the correlation between MRI data and functional evaluation of the hip joint.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Agnieszka Lewinska
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Address
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2nd Department of Clinical Radiology, Medical University of Warsaw
1a Stefana Banacha St., 02-097 Warsaw, Poland
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Country
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Poland
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Phone
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+48225992300
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Fax
96182
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Email
96182
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[email protected]
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Contact person for public queries
Name
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Ms Agnieszka Lewinska
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Address
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2nd Department of Clinical Radiology, Medical University of Warsaw
1a Stefana Banacha St., 02-097 Warsaw, Poland
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Country
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Poland
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Phone
96183
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+48225992300
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Fax
96183
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Email
96183
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[email protected]
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Contact person for scientific queries
Name
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Ms Agnieszka Lewinska
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Address
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2nd Department of Clinical Radiology, Medical University of Warsaw
1a Stefana Banacha St., 02-097 Warsaw, Poland
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Country
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Poland
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Phone
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+48225992300
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Fax
96184
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Email
96184
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
4478
Ethical approval
378281-(Uploaded-02-09-2019-02-25-07)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Basic results
No
378281-(Uploaded-27-11-2019-04-16-45)-Basic results summary.docx
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Assessing the impact of a long-term physiotherapy program on hip function in patients with osteoarthritis: The role of patient-reported and assessor-observed outcome measures.
2022
https://dx.doi.org/10.5114/ms.2022.122388
Embase
The use of scoring hip osteoarthritis with mri as an assessment tool for physiotherapeutic treatment in patients with osteoarthritis of the hip.
2022
https://dx.doi.org/10.3390/jcm11010017
N.B. These documents automatically identified may not have been verified by the study sponsor.
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