Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery?
Primary Purpose
Fractured Hip
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
time to first ambulation
Sponsored by
About this trial
This is an interventional treatment trial for Fractured Hip focused on measuring fracture, hip, ambulation
Eligibility Criteria
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) - 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. -
Sites / Locations
- The Alfred Hospital
Outcomes
Primary Outcome Measures
functional outcome day 7 post-operation
Secondary Outcome Measures
discharge destination
length of stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00224367
Brief Title
Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery?
Official Title
Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery?: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2005
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bayside Health
4. Oversight
5. Study Description
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.
Detailed Description
Methods Inclusions: 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).
Exclusions: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.
Sixty eligible patients were randomly allocated, using a computer generated program, into one of two groups.
Management All patients received routine, standard post-operative medical and nursing clinical care, as currently practiced at The Alfred. All patients were transferred to sit out of bed as early as possible after surgery.
Ambulation The physiotherapy ambulation re-education program was implemented once per day over 7 days for all participants. The time to first walk differed between the groups.
Data collection On admission: gender, age, preoperative mobility, social supports, mental ability and medical comorbidity,pre-existing medical comorbidity (cardiac, respiratory, neurological, diabetes) and mental ability.
Additional data from each patients medical record including: type of surgical fixation (nail/screw and plate, hemi-arthroplasty), wait time to surgery, time surgery completed, and time to first sit out of bed and time to first walk.
Outcome measures The primary outcome measure was the patient's functional level, represented by the distance they walked and the level of assistance required to transfer from supine to sit and sit to stand and to negotiate one step, on day-7 post surgery.
Secondary outcome measures included discharge destination and length of stay in the acute care (days from admission to discharge from The Alfred).
Data analysis Statistical analysis was performed using SAS version 8.2. (SAS Institute Inc.,Carv, NC, USA). Continuous variables were compared using student t-tests and validated using Wilcoxon rank sum tests. Categorical variables were compared using chi-square tests for equal proportion. A two-sided p-value of 0.05 was considered to be statistically significant.
Sample size A difference between groups equivalent to one standard deviation was perceived to be of clinical importance. With 30 subjects per group, this study had a 97% power to detect a difference equal to one standard deviation with a two-sided p-value of 0.05. A minimum of 16 subjects per subgroup was required for this study to have an 80% power to detect a difference equal to one standard deviation with a two-sided p-value of 0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractured Hip
Keywords
fracture, hip, ambulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
time to first ambulation
Primary Outcome Measure Information:
Title
functional outcome day 7 post-operation
Secondary Outcome Measure Information:
Title
discharge destination
Title
length of stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) -
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonie B Oldmeadow, D.Physio
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3141
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
36070134
Citation
Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
Results Reference
derived
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Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery?
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