Hip FracturesHIP4hipsNCT02088437
High Intensity Physiotherapy for Hip Fractures
A study testing Intensive physiotherapy in people with Hip Fractures, run by The Alfred at 1 site in Australia.
Trial summary
Every day, more than 40 Australian break their hip, Most are over the age of sixty five. Hip fractures are a significant problem for the older people, the hospital system and community as a whole because of the increasing numbers of fractures and the cost of hospitalisation and ongoing care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Intensive physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2014to Sep 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Admission to The Alfred with an isolated hip fracture and treated with internal fixation, aged 65 or above
Who cannot join
- fracture is in the sub-trochanteric region of the femur,
- if it is pathological,
- if post operative orders are for non-weight bearing on the operated hip,
- if they were unable to mobilise independently (or with gait aid) prior to admission,
- or if they were admitted from a nursing home.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Intensity Physiotherapy for Hip Fractures in the Acute Hospital Setting
Every day, more than 40 Australian break their hip, Most are over the age of sixty five. Hip fractures are a significant problem for the older people, the hospital system and community as a whole because of the increasing numbers of fractures and the cost of hospitalisation and ongoing care. After one year, less than half of all people with a hip fracture can walk as well as they did before the fracture. Physiotherapy in the acute hospital setting is an integral part of patient care, although the intensity of physiotherapy a patient receives is variable and the optimal number of treatment sessions per day remains unknown. Studies in other patient groups have shown that increased physiotherapy can improve patient outcomes by increasing muscle strength and mobility. It can also reduce the negative effects of bed rest such as muscle wasting, blood clots in the lungs or leg veins and chest infections such as pneumonia. This study aims to investigate the effectiveness of an intensive physiotherapy program in hip fracture patients to further understand this and the effect it has on patient function.
In this research the investigators will randomly allocate patients into 2 groups; usual care and intensive physiotherapy. The usual care group will have physiotherapy treatment daily whereas the intensive physiotherapy group will have an additional daily treatment by a physiotherapist as well as a daily treatment by an allied health assistant. The objectives are to achieve better functional outcomes in the patient's hospital stay (ie improved mobility), reduce the time for patients to be physically ready to go home, increase the number of patients able to go directly home or to fast stream rehabilitation (rather than a slow stream option).
If increased intensity of physiotherapy is found to improve patient's mobility outcomes, this research will provide the confidence to endorse a change to current clinical practice.
- Conditions
- Hip Fractures
- Being tested
- Intensive physiotherapy, Usual Care
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive physiotherapyOther
additional once daily physiotherapy and once daily allied health assistant intervention (equals two more treatments) whilst an inpatient in acute hospital
Usual CareOther
once daily physiotherapy whilst acute hospital inpatient
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | usual care physiotherapy - once daily treatment whilst inpatient in acute hospital Receives: Other: Usual Care |
| Intensive physiotherapy | Experimental | additional once daily physiotherapy and once daily allied health assistant intervention Receives: Other: Intensive physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified IOWA Level of Assistance Scale
Functional score measuring 6 mobility domains
Measured: 5 days
Secondary outcomes (7)
length of stay - acute and rehabilitation
the length of acute hospital stay and rehabilitation stay - until discharge home or to a long term facility
Measured: participants will be followed for duration of hospital stay - average one month
timed up and go
Measured: 5 days
Glasgow Outcomes Score -Extended
Measured: 6 months
discharge destination
discharge destination from the acute hospital - options include: home, fast stream rehabilitation, slow stream rehabilitation, long term facility
Measured: participants will be followed until discharge from the acute hospital - average 10 days
physical readiness for discharge
when a patient is deemed physically ready go home - eg can access their house and mobilise within house and outdoors
Measured: average one month
12-Item Short Form Health Survey (SF-12)
Measured: 6 months
EuroQOL five dimensions questionnaire (EQ-5D)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Kimmel, The Alfred
- Investigators
- Lara A Kimmel, B.Physio, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088437
- Sponsor's protocol ID
- 32/14
- Acronym
- HIP4hips
- Status last verified
- Dec 2015
- First submitted
- 6 Mar 2014
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kimmel LA, Liew SM, Sayer JM, Holland AE. HIP4Hips (High Intensity Physiotherapy for Hip fractures in the acute hospital setting): a randomised controlled trial. Med J Aust. 2016 Jul 18;205(2):73-8. doi: 10.5694/mja16.00091.
PubMed 27456448
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Physiotherapy for Hip Fractures in the Acute Hospital Setting
- ClinicalTrials.gov ID
- NCT02088437
- Acronym / sponsor ID
- HIP4hips / 32/14
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Mar 2014 (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.
Every day, more than 40 Australian break their hip, Most are over the age of sixty five. Hip fractures are a significant problem for the older people, the hospital system and community as a whole because of the increasing numbers of fractures and the cost of hospitalisation and ongoing care. After one year, less than half of all people with a hip fracture can walk as well as they did before the fracture. Physiotherapy in the acute hospital setting is an integral part of patient care, although the intensity of physiotherapy a patient receives is variable and the optimal number of treatment sessions per day remains unknown. Studies in other patient groups have shown that increased physiotherapy can improve patient outcomes by increasing muscle strength and mobility. It can also reduce the negative effects of bed rest such as muscle wasting, blood clots in the lungs or leg veins and chest infections such as pneumonia. This study aims to investigate the effectiveness of an intensive physiotherapy program in hip fracture patients to further understand this and the effect it has on patient function.
In this research the investigators will randomly allocate patients into 2 groups; usual care and intensive physiotherapy. The usual care group will have physiotherapy treatment daily whereas the intensive physiotherapy group will have an additional daily treatment by a physiotherapist as well as a daily treatment by an allied health assistant. The objectives are to achieve better functional outcomes in the patient's hospital stay (ie improved mobility), reduce the time for patients to be physically ready to go home, increase the number of patients able to go directly home or to fast stream rehabilitation (rather than a slow stream option).
If increased intensity of physiotherapy is found to improve patient's mobility outcomes, this research will provide the confidence to endorse a change to current clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual Careusual care physiotherapy - once daily treatment whilst inpatient in acute hospital |
| Intensive physiotherapy | Experimental | Other: Intensive physiotherapyadditional once daily physiotherapy and once daily allied health assistant intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Admission to The Alfred with an isolated hip fracture and treated with internal fixation, aged 65 or above
Key exclusion criteria (5 listed)
- fracture is in the sub-trochanteric region of the femur,
- if it is pathological,
- if post operative orders are for non-weight bearing on the operated hip,
- if they were unable to mobilise independently (or with gait aid) prior to admission,
- or if they were admitted from a nursing home.
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 |
|---|---|---|
| Intensive physiotherapyadditional once daily physiotherapy and once daily allied health assistant intervention (equals two more treatments) whilst an inpatient in acute hospital | Other | Intensive physiotherapy |
| Usual Careonce daily physiotherapy whilst acute hospital inpatient | Other | Usual care |
Primary outcome
modified IOWA Level of Assistance Scale
Time frame: 5 days
Functional score measuring 6 mobility domains
7 secondary outcomes
length of stay - acute and rehabilitation
Time frame: participants will be followed for duration of hospital stay - average one month
timed up and go
Time frame: 5 days
Glasgow Outcomes Score -Extended
Time frame: 6 months
discharge destination
Time frame: participants will be followed until discharge from the acute hospital - average 10 days
physical readiness for discharge
Time frame: average one month
12-Item Short Form Health Survey (SF-12)
Time frame: 6 months
EuroQOL five dimensions questionnaire (EQ-5D)
Time frame: 6 months
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 31 Dec 2015.
- Derived from this study: PubMed 27456448Kimmel LA, Liew SM, Sayer JM, Holland AE. HIP4Hips (High Intensity Physiotherapy for Hip fractures in the acute hospital setting): a randomised controlled trial. Med J Aust. 2016 Jul 18;205(2):73-8. doi: 10.5694/mja16.00091.
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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.
Lara A Kimmel, B.Physio principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive physiotherapy in people with Hip Fractures, run by The Alfred 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 1 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 31 Dec 2015. 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?
modified IOWA Level of Assistance Scale (time frame: 5 days). 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 NCT02088437, which also lists 1 linked publication.
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 31 Dec 2015.