Total Hip Joint ReplacementNCT00222300
A Targeted Strengthening Program Following Total Hip Replacement.
A study testing Strength training program in people with Total Hip Joint Replacement, run by University of Melbourne at 1 site in Australia.
Trial summary
Total Hip Replacement (THR) is a common surgical procedure performed in people with hip osteoarthritis and appears to be effective in relieving pain and improving function. However significant wasting and weakness of the hip and knee muscles persists post-operatively. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Total Hip Joint Replacement
- What is being tested?
- Strength training program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- May 2003to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- primary uncomplicated total hip joint replacement 6-8 weeks prior to enrolment.
- able to walk 45m independently with or without walking aid.
- able to comprehend instructions
- prior joint replacement on the other side at least 12 months previously
Who cannot join
- unable to fully weight-bear on affected limb
- pre-existing neurological or orthopaedic condition affecting gait
- revision surgery
- post-operative complications, e.g. wound infection
- uncontrolled systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Total Hip Replacement (THR) is a common surgical procedure performed in people with hip osteoarthritis and appears to be effective in relieving pain and improving function. However significant wasting and weakness of the hip and knee muscles persists post-operatively. Although relief of pain and improvement of function are important outcomes following THR, weakness of the hip and knee muscles reduces a person's ability to manage stairs, slopes, public transport and results in persistent gait abnormalities. Since lower limb weakness is one of the risk factors for falls, it is important that patients undergo a strengthening program post-operatively. The hypothesis is that lower limb strength and function will be better in patients who undergo a strengthening program post-operatively than in those who have usual care.
Read the detailed description
Total Hip Replacement (THR) is a common surgical procedure performed in people with hip osteoarthritis and appears to be effective in relieving pain and improving function. However significant quadriceps atrophy and weakness persist post-operatively. Although relief of pain and improvement of function are important outcomes following THR, weakness of the hip and knee muscles reduces a person's ability to manage stairs, slopes, public transport and results in persistent gait abnormalities. Since lower limb weakness is one of the risk factors for falls, it is important that this is appropriately addressed.
The study examines the effect of an eight-week task-specific strengthening program on lower limb function in patients following THR in a randomized controlled trial. The experimental program is being conducted as a circuit in a gymnasium environment. Changes on specific measures of physical function of patients in the Experimental Group will be compared with those of patients in a Control Group who will continue with the standard care program provided at Austin Health.
Outcome measures include:lower limb muscle strength using a step test, pain, stiffness, and function as reported on the WOMAC questionnaire, quality of life using the AQoL questionnaire, the Timed Up-and-Go test. Walking tests will also be conducted. These include:
- Walking pattern, recorded on an instrumented mat
- Walking endurance measured by the 6-minute walk test.
- Analysis of hip joint torques using 3-D motion analysis.
- Conditions
- Total Hip Joint Replacement
- Being tested
- Strength training program
- Keywords
- Total hip replacement, Strength training, Gait analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limb strength using a step test
Secondary outcomes (5)
Pain, stiffness and function using the WOMAC questionnaire.
Function using the Timed Up-and-Go Test.
Quality of life using the AQoL
Spatiotemporal measures of walking using an instrumented mat.
Hip joint torques using 3-D motion analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Joint ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Investigators
- Mary P Galea, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222300
- Sponsor's protocol ID
- H2002/01532
- Status last verified
- Oct 2003
- First submitted
- 13 Sep 2005
- Last updated
- 8 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Targeted Strengthening Program Following Total Hip Replacement.
- ClinicalTrials.gov ID
- NCT00222300
- Acronym / sponsor ID
- H2002/01532
- Conditions
- Total Hip Joint Replacement
- Keywords
- Total hip replacement, Strength training, Gait analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- May 2003
- Study completion
- Dec 2005
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total Hip Replacement (THR) is a common surgical procedure performed in people with hip osteoarthritis and appears to be effective in relieving pain and improving function. However significant wasting and weakness of the hip and knee muscles persists post-operatively. Although relief of pain and improvement of function are important outcomes following THR, weakness of the hip and knee muscles reduces a person's ability to manage stairs, slopes, public transport and results in persistent gait abnormalities. Since lower limb weakness is one of the risk factors for falls, it is important that patients undergo a strengthening program post-operatively. The hypothesis is that lower limb strength and function will be better in patients who undergo a strengthening program post-operatively than in those who have usual care.
Detailed description
Total Hip Replacement (THR) is a common surgical procedure performed in people with hip osteoarthritis and appears to be effective in relieving pain and improving function. However significant quadriceps atrophy and weakness persist post-operatively. Although relief of pain and improvement of function are important outcomes following THR, weakness of the hip and knee muscles reduces a person's ability to manage stairs, slopes, public transport and results in persistent gait abnormalities. Since lower limb weakness is one of the risk factors for falls, it is important that this is appropriately addressed.
The study examines the effect of an eight-week task-specific strengthening program on lower limb function in patients following THR in a randomized controlled trial. The experimental program is being conducted as a circuit in a gymnasium environment. Changes on specific measures of physical function of patients in the Experimental Group will be compared with those of patients in a Control Group who will continue with the standard care program provided at Austin Health.
Outcome measures include:lower limb muscle strength using a step test, pain, stiffness, and function as reported on the WOMAC questionnaire, quality of life using the AQoL questionnaire, the Timed Up-and-Go test. Walking tests will also be conducted. These include:
- Walking pattern, recorded on an instrumented mat
- Walking endurance measured by the 6-minute walk test.
- Analysis of hip joint torques using 3-D motion analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- primary uncomplicated total hip joint replacement 6-8 weeks prior to enrolment.
- able to walk 45m independently with or without walking aid.
- able to comprehend instructions
- prior joint replacement on the other side at least 12 months previously
Key exclusion criteria (5 listed)
- unable to fully weight-bear on affected limb
- pre-existing neurological or orthopaedic condition affecting gait
- revision surgery
- post-operative complications, e.g. wound infection
- uncontrolled systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength training program | Behavioural | – |
Primary outcome
Lower limb strength using a step test
5 secondary outcomes
Pain, stiffness and function using the WOMAC questionnaire.
Function using the Timed Up-and-Go Test.
Quality of life using the AQoL
Spatiotemporal measures of walking using an instrumented mat.
Hip joint torques using 3-D motion analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2006.
Related trials for Total Hip Joint Replacement
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruitingObservational study
Daycase Hip and Knee Arthroplasty in Møre and Romsdal Trial
Knee Osteoarthritis, Hip Osteoarthritis
Recruiting
Hip Replacement System (HRS-P) in Primary Total Hip Arthroplasty
Osteoarthritis of Hip
Recruiting
Safety and Effectiveness of the HIT Reverse HRS
Degenerative Joint Disease, Osteoarthritis, Hip
Active, not recruitingObservational study
Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA
Advanced Degeneration of the Hip Joint, Revision of the Hip Joint
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary P Galea, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training program in people with Total Hip Joint Replacement, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower limb strength using a step test. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2006.