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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
High Intensity Physiotherapy for Hip Fractures in the Acute Hospital Setting
Secondary ID [1] 0 0
32/14
Universal Trial Number (UTN)
Trial acronym
HIP4hips
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
modified IOWA Level of Assistance Scale
Timepoint [1] 0 0
5 days
Secondary outcome [1] 0 0
length of stay - acute and rehabilitation
Timepoint [1] 0 0
participants will be followed for duration of hospital stay - average one month
Secondary outcome [2] 0 0
timed up and go
Timepoint [2] 0 0
5 days
Secondary outcome [3] 0 0
Glasgow Outcomes Score -Extended
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
discharge destination
Timepoint [4] 0 0
participants will be followed until discharge from the acute hospital - average 10 days
Secondary outcome [5] 0 0
physical readiness for discharge
Timepoint [5] 0 0
average one month
Secondary outcome [6] 0 0
12-Item Short Form Health Survey (SF-12)
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
EuroQOL five dimensions questionnaire (EQ-5D)
Timepoint [7] 0 0
6 months

Eligibility
Key inclusion criteria
- Admission to The Alfred with an isolated hip fracture and treated with internal
fixation, aged 65 or above
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02088437
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lara A Kimmel, B.Physio
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02088437