Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224367
Status:
COMPLETED
Last Update Posted:
2005-09-23
First Post:
2005-09-21
Brief Title:
Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery
Sponsor:
Bayside Health
Organization:
Bayside Health
Study Overview
Official Title:
Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2005-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 17000 in 2004 to 60000 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 outcomesOur hypothesis was that early mobilisation would accelerate functional recovery after hip fracture surgery
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 outcomesOur 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
Exclusionsfracture 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 comorbiditypre-existing medical comorbidity cardiac respiratory neurological diabetes and mental ability
Additional data from each patients medical record including type of surgical fixation nailscrew 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 patients 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 82 SAS Institute IncCarv 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 005 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 005 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 005
Exclusionsfracture 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 comorbiditypre-existing medical comorbidity cardiac respiratory neurological diabetes and mental ability
Additional data from each patients medical record including type of surgical fixation nailscrew 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 patients 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 82 SAS Institute IncCarv 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 005 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 005 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Award number A33429 | None | None | None |