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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/NCT00224367




Registration number
NCT00224367
Ethics application status
Date submitted
21/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005

Titles & IDs
Public title
Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery?
Scientific title
Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery?: A Randomised Controlled Trial
Secondary ID [1] 0 0
Award number A33429
Secondary ID [2] 0 0
T10414
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractured Hip 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - time to first ambulation

Behaviour: time to first ambulation
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
functional outcome day 7 post-operation
Timepoint [1] 0 0
Secondary outcome [1] 0 0
discharge destination
Timepoint [1] 0 0
Secondary outcome [2] 0 0
length of stay
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
Consecutive patients admitted via the emergency department to The Alfred hospital
Melbourne, for surgical fixation of an acute fracture of the hip (by a compression screw
and plate or a hemiarthroplasty) -
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
fracture was pathological, postoperative orders were for non-weight bearing on the operated
hip, the patient was admitted from a nursing home or the patient was non-ambulant
pre-morbidly. -

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?



Intervention assignment
Single group
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
1/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3141 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Hip fractures are a significant problem for healthcare providers due to the increasing
incidence of fractures in an ageing population. Hip fracture is the most frequent fracture
for people over 80 years of age and the second most frequent for those over 65 years. It is
projected that by 2051, 23% of the Australian population will be older than 65 and the number
of hip fractures will rise fourfold (17,000 in 2004, to 60,000 in 2051).

Evidence-based clinical practice guidelines regarding management of hip fracture were
published in the Medical Journal of Australia in 1999 and updated in 2003. Seventeen aspects
of treatment were systematically reviewed, including mobilisation after surgery. Early
assisted ambulation within 48 hours post surgery was recommended (Chilov 2003 p 490).
However, the recommendation was based on observational (level 3) evidence only.

Early mobilization post surgery is resource intensive. Early mobilization is challenging and
uncomfortable for the patient and requires the assistance of one or sometimes two,
physiotherapists available seven days per week. Benefits must be rigorously evaluated to
justify recommendation. We undertook a randomized controlled trial of the effect of two
different 'time to first ambulation' intervals after hip fracture surgery on patient and
hospital outcomes.Our hypothesis was that early mobilisation would accelerate functional
recovery after hip fracture surgery.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00224367
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leonie B Oldmeadow, D.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/NCT00224367