- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02088437
High Intensity Physiotherapy for Hip Fractures (HIP4hips)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3181
- The Alfred
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Admission to The Alfred with an isolated hip fracture and treated with internal fixation, aged 65 or above
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual care
usual care physiotherapy - once daily treatment whilst inpatient in acute hospital
|
once daily physiotherapy whilst acute hospital inpatient
|
Experimental: Intensive physiotherapy
additional once daily physiotherapy and once daily allied health assistant intervention
|
additional once daily physiotherapy and once daily allied health assistant intervention (equals two more treatments) whilst an inpatient in acute hospital
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
modified IOWA Level of Assistance Scale
Time Frame: 5 days
|
Functional score measuring 6 mobility domains
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
length of stay - acute and rehabilitation
Time Frame: participants will be followed for duration of hospital stay - average one month
|
the length of acute hospital stay and rehabilitation stay - until discharge home or to a long term facility
|
participants will be followed for duration of hospital stay - average one month
|
timed up and go
Time Frame: 5 days
|
5 days
|
|
Glasgow Outcomes Score -Extended
Time Frame: 6 months
|
6 months
|
|
discharge destination
Time Frame: participants will be followed until discharge from the acute hospital - average 10 days
|
discharge destination from the acute hospital - options include: home, fast stream rehabilitation, slow stream rehabilitation, long term facility
|
participants will be followed until discharge from the acute hospital - average 10 days
|
physical readiness for discharge
Time Frame: average one month
|
when a patient is deemed physically ready go home - eg can access their house and mobilise within house and outdoors
|
average one month
|
12-Item Short Form Health Survey (SF-12)
Time Frame: 6 months
|
6 months
|
|
EuroQOL five dimensions questionnaire (EQ-5D)
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lara A Kimmel, B.Physio, The Alfred
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32/14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fractures
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Smith & Nephew, Inc.Terminated
-
Texas Tech University Health Sciences Center, El...CompletedHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)United States
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Carilion ClinicCompleted
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FH ORTHORecruitingHip Fractures | Hip DiseaseFrance
-
Zhenjiang First People's HospitalCompletedHip Fractures | Hip DiseaseChina
-
Bayside HealthCompleted
-
Oslo University HospitalDiakonhjemmet HospitalCompletedHip Fractures | Trochanteric Fractures | Intertrochanteric FracturesNorway
-
Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
-
University of Missouri-ColumbiaUniversity of Alabama at Birmingham; Medical College of Wisconsin; University...CompletedHip Fractures | Pelvic Fractures | Acetabular FracturesUnited States
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