Hip Surgery CorrectiveFEATHERNCT01683201
Functional Exercise After Total Hip Replacement
A study testing Functional exercise class in people with Hip Surgery Corrective, run by Health Service Executive, Ireland.
Trial summary
The aim of this research project is to evaluate the efficacy of a specific functional exercise programme to improve pain, stiffness and physical function in patients post total hip replacement from week 12 to week 18 post surgery. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Surgery Corrective
- What is being tested?
- Functional exercise class
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Feb 2015
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 12 weeks post primary THR for osteoarthritis
- Age 50 years and above
- Able to read and understand and instructions in English
- Willing to attend classes twice weekly for 8 weeks
- Able to participate in an exercise programme without physical assistance
- Able to Mobilize independently 15m without crutches and /or stick -Passed by the referring Orthopaedic Consultant as suitable for inclusion at six week appointment -
Who cannot join
- Medically unstable
- Any central or peripheral nervous system deficits
- Any underlying terminal disease -Any suspicion of infection following joint replacement -
About this study
Official title: Functional Exercise After Total Hip Replacement: A Randomised Controlled Late Phase Trial
The aim of this research project is to evaluate the efficacy of a specific functional exercise programme to improve pain, stiffness and physical function in patients post total hip replacement from week 12 to week 18 post surgery.
Read the detailed description
This will be a single blind randomised controlled trial with two arms. 70 subjects post primary total hip replacement will be randomised either to a functional; exercise group (n=35) or to a control group following usual care (n=35).
Blinded outcome assessments will be carried out on all subjects by the principal investigator using the Western Ontario and Mc Master arthritis index on day 5 , week 12 aand week 18.
Secondary outcomes measurements will also be collated at week 12 and week 18 including SF 12, 6 min walk test, Dynamometry, and a blinded radiologist will also measure glut med cross sectional area using real time ultrasound at week 12 and week 18.
- Conditions
- Hip Surgery Corrective
- Being tested
- Functional exercise class, usual care group
- Keywords
- Total hip replacement, Functional exercise class, Randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional exercise classProcedure or surgery
Functional exercise class running twice weekly for six weeks from week 12 to week 18
usual care groupProcedure or surgery
Usual care group adhere to post operative instructions given on discharge from hospital
| Study group | Role | What they receive |
|---|---|---|
| Functional exercise class | Experimental | Functional exercise class 45 mins twice weekly from week 12 to week 18 Receives: Procedure: Functional exercise class |
| Usual Care Group | Placebo comparator | Usual Care Receives: Procedure: usual care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC Western Ontario and Mc Master osteoarthritis index questionaire
Multi dimensional self administered health status instrument used to measure changes in the dimensions of pain stiffness and function.
Measured: 3 YEARS
Secondary outcomes (4)
Six minute walk test,
Physical performance test used to measure the distance covered in a set timeframe.
Measured: 3 years
Short form SF- 12
Self completed questionaire that measures health status and quality of life under eight multi item scales measuring physical function, bodily pain, role limitation due to physical health problems, general health, vitality, social function, role limitation due to emotional problems and mental health.
Measured: 3 YEARS
HiP Abduction Strength Dynamometry
Assessment scale of ability to maintain balance both statically and whilst performing various functional tasks will be completed by the principal investigator at week 12 and repeated for all patients at week 18.
Measured: 3 years
Real time ultrasound imaging of the gluteus medius muscles
Patients will be scanned by a blinded radiologist to measure cross sectional area of the gluteus medius muscle at 12 weeks and again at 18 weeks.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip Surgery CorrectiveStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Service Executive, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brenda Monaghan, Health Service Executive, Ireland
- Investigators
- Brenda M Monaghan, BSc, MSc, Principal investigator, HSE Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683201
- Sponsor's protocol ID
- HPF/2011/60
- Acronym
- FEATHER
- Status last verified
- Mar 2015
- First submitted
- 7 Sep 2012
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Monaghan B, Cunningham P, Harrington P, Hing W, Blake C, O' Dohertya D, Cusack T. Randomised controlled trial to evaluate a physiotherapy-led functional exercise programme after total hip replacement. Physiotherapy. 2017 Sep;103(3):283-288. doi: 10.1016/j.physio.2016.01.003. Epub 2016 Feb 15.
PubMed 27126617Monaghan B, Grant T, Hing W, Cusack T. Functional exercise after total hip replacement (FEATHER): a randomised control trial. BMC Musculoskelet Disord. 2012 Nov 28;13:237. doi: 10.1186/1471-2474-13-237.
PubMed 23190932
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Exercise After Total Hip Replacement: A Randomised Controlled Late Phase Trial
- ClinicalTrials.gov ID
- NCT01683201
- Acronym / sponsor ID
- FEATHER / HPF/2011/60
- Conditions
- Hip Surgery Corrective
- Keywords
- Total hip replacement, Functional exercise class, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Health Service Executive, IrelandUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 11 Sep 2012 (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.
The aim of this research project is to evaluate the efficacy of a specific functional exercise programme to improve pain, stiffness and physical function in patients post total hip replacement from week 12 to week 18 post surgery.
Detailed description
This will be a single blind randomised controlled trial with two arms. 70 subjects post primary total hip replacement will be randomised either to a functional; exercise group (n=35) or to a control group following usual care (n=35).
Blinded outcome assessments will be carried out on all subjects by the principal investigator using the Western Ontario and Mc Master arthritis index on day 5 , week 12 aand week 18.
Secondary outcomes measurements will also be collated at week 12 and week 18 including SF 12, 6 min walk test, Dynamometry, and a blinded radiologist will also measure glut med cross sectional area using real time ultrasound at week 12 and week 18.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional exercise class | Experimental | Procedure: Functional exercise classFunctional exercise class 45 mins twice weekly from week 12 to week 18 |
| Usual Care Group | Placebo comparator | Procedure: usual care groupUsual Care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 12 weeks post primary THR for osteoarthritis
- Age 50 years and above
- Able to read and understand and instructions in English
- Willing to attend classes twice weekly for 8 weeks
- Able to participate in an exercise programme without physical assistance
Key exclusion criteria (3 listed)
- Medically unstable
- Any central or peripheral nervous system deficits
- Any underlying terminal disease -Any suspicion of infection following joint replacement -
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 |
|---|---|---|
| Functional exercise classFunctional exercise class running twice weekly for six weeks from week 12 to week 18 | Procedure or surgery | Functional exercise class |
| usual care groupUsual care group adhere to post operative instructions given on discharge from hospital | Procedure or surgery | Usual Care Group |
Primary outcome
WOMAC Western Ontario and Mc Master osteoarthritis index questionaire
Time frame: 3 YEARS
Multi dimensional self administered health status instrument used to measure changes in the dimensions of pain stiffness and function.
4 secondary outcomes
Six minute walk test,
Time frame: 3 years
Short form SF- 12
Time frame: 3 YEARS
HiP Abduction Strength Dynamometry
Time frame: 3 years
Real time ultrasound imaging of the gluteus medius muscles
Time frame: 3 years
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 20 Mar 2015.
- Derived from this study: PubMed 27126617Monaghan B, Cunningham P, Harrington P, Hing W, Blake C, O' Dohertya D, Cusack T. Randomised controlled trial to evaluate a physiotherapy-led functional exercise programme after total hip replacement. Physiotherapy. 2017 Sep;103(3):283-288. doi: 10.1016/j.physio.2016.01.003. Epub 2016 Feb 15.
- Derived from this study: PubMed 23190932Monaghan B, Grant T, Hing W, Cusack T. Functional exercise after total hip replacement (FEATHER): a randomised control trial. BMC Musculoskelet Disord. 2012 Nov 28;13:237. doi: 10.1186/1471-2474-13-237.
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Cerebral Palsy, Hip Surgery Corrective
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.
Brenda M Monaghan, BSc, MSc principal investigator
HSE Ireland
Questions about this trial
What is this clinical trial studying?
A study testing Functional exercise class in people with Hip Surgery Corrective, run by Health Service Executive, Ireland.
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 6 inclusion and 3 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 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
WOMAC Western Ontario and Mc Master osteoarthritis index questionaire (time frame: 3 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01683201, which also lists 2 linked publications.
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 20 Mar 2015.