Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery?

September 21, 2005 updated by: Bayside Health

Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery?: A Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3141
        • The Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
functional outcome day 7 post-operation

Secondary Outcome Measures

Outcome Measure
length of stay
discharge destination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Investigators

  • Principal Investigator: Leonie B Oldmeadow, D.Physio, The Alfred

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 23, 2005

Study Record Updates

Last Update Posted (Estimate)

September 23, 2005

Last Update Submitted That Met QC Criteria

September 21, 2005

Last Verified

February 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T10414
  • Award number A33429

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.

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