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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02088437
Registration number
NCT02088437
Ethics application status
Date submitted
6/03/2014
Date registered
17/03/2014
Date last updated
31/12/2015
Titles & IDs
Public title
High Intensity Physiotherapy for Hip Fractures
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Scientific title
High Intensity Physiotherapy for Hip Fractures in the Acute Hospital Setting
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Secondary ID [1]
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32/14
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Universal Trial Number (UTN)
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Trial acronym
HIP4hips
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip Fractures
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Intensive physiotherapy
Other interventions - Usual Care
Active comparator: Usual care - usual care physiotherapy - once daily treatment whilst inpatient in acute hospital
Experimental: Intensive physiotherapy - additional once daily physiotherapy and once daily allied health assistant intervention
Other interventions: Intensive physiotherapy
additional once daily physiotherapy and once daily allied health assistant intervention (equals two more treatments) whilst an inpatient in acute hospital
Other interventions: Usual Care
once daily physiotherapy whilst acute hospital inpatient
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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modified IOWA Level of Assistance Scale
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Assessment method [1]
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Functional score measuring 6 mobility domains
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Timepoint [1]
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5 days
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Secondary outcome [1]
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length of stay - acute and rehabilitation
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Assessment method [1]
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the length of acute hospital stay and rehabilitation stay - until discharge home or to a long term facility
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Timepoint [1]
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participants will be followed for duration of hospital stay - average one month
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Secondary outcome [2]
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timed up and go
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Assessment method [2]
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Timepoint [2]
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5 days
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Secondary outcome [3]
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Glasgow Outcomes Score -Extended
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Assessment method [3]
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Timepoint [3]
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6 months
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Secondary outcome [4]
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discharge destination
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Assessment method [4]
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discharge destination from the acute hospital - options include: home, fast stream rehabilitation, slow stream rehabilitation, long term facility
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Timepoint [4]
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participants will be followed until discharge from the acute hospital - average 10 days
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Secondary outcome [5]
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physical readiness for discharge
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Assessment method [5]
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when a patient is deemed physically ready go home - eg can access their house and mobilise within house and outdoors
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Timepoint [5]
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average one month
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Secondary outcome [6]
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12-Item Short Form Health Survey (SF-12)
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Assessment method [6]
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Timepoint [6]
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6 months
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Secondary outcome [7]
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EuroQOL five dimensions questionnaire (EQ-5D)
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Assessment method [7]
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Timepoint [7]
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6 months
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Eligibility
Key inclusion criteria
* Admission to The Alfred with an isolated hip fracture and treated with internal fixation, aged 65 or above
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Minimum age
65
Years
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Maximum age
No limit
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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
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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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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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2015
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Sample size
Target
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Accrual to date
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Final
92
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
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3181 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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. 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.
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Trial website
https://clinicaltrials.gov/study/NCT02088437
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Lara A Kimmel, B.Physio
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Address
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The Alfred
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02088437
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