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High Intensity Physiotherapy for Hip Fractures (HIP4hips)

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Intensive physiotherapy
Usual Care
Sponsored by
The Alfred
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admission to The Alfred with an isolated hip fracture and treated with internal fixation, aged 65 or above

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.

Sites / Locations

  • The Alfred

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

Intensive physiotherapy

Arm Description

usual care physiotherapy - once daily treatment whilst inpatient in acute hospital

additional once daily physiotherapy and once daily allied health assistant intervention

Outcomes

Primary Outcome Measures

modified IOWA Level of Assistance Scale
Functional score measuring 6 mobility domains

Secondary Outcome Measures

length of stay - acute and rehabilitation
the length of acute hospital stay and rehabilitation stay - until discharge home or to a long term facility
timed up and go
Glasgow Outcomes Score -Extended
discharge destination
discharge destination from the acute hospital - options include: home, fast stream rehabilitation, slow stream rehabilitation, long term facility
physical readiness for discharge
when a patient is deemed physically ready go home - eg can access their house and mobilise within house and outdoors
12-Item Short Form Health Survey (SF-12)
EuroQOL five dimensions questionnaire (EQ-5D)

Full Information

First Posted
March 6, 2014
Last Updated
December 29, 2015
Sponsor
The Alfred
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1. Study Identification

Unique Protocol Identification Number
NCT02088437
Brief Title
High Intensity Physiotherapy for Hip Fractures
Acronym
HIP4hips
Official Title
High Intensity Physiotherapy for Hip Fractures in the Acute Hospital Setting
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Alfred

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
usual care physiotherapy - once daily treatment whilst inpatient in acute hospital
Arm Title
Intensive physiotherapy
Arm Type
Experimental
Arm Description
additional once daily physiotherapy and once daily allied health assistant intervention
Intervention Type
Other
Intervention Name(s)
Intensive physiotherapy
Intervention Description
additional once daily physiotherapy and once daily allied health assistant intervention (equals two more treatments) whilst an inpatient in acute hospital
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
once daily physiotherapy whilst acute hospital inpatient
Primary Outcome Measure Information:
Title
modified IOWA Level of Assistance Scale
Description
Functional score measuring 6 mobility domains
Time Frame
5 days
Secondary Outcome Measure Information:
Title
length of stay - acute and rehabilitation
Description
the length of acute hospital stay and rehabilitation stay - until discharge home or to a long term facility
Time Frame
participants will be followed for duration of hospital stay - average one month
Title
timed up and go
Time Frame
5 days
Title
Glasgow Outcomes Score -Extended
Time Frame
6 months
Title
discharge destination
Description
discharge destination from the acute hospital - options include: home, fast stream rehabilitation, slow stream rehabilitation, long term facility
Time Frame
participants will be followed until discharge from the acute hospital - average 10 days
Title
physical readiness for discharge
Description
when a patient is deemed physically ready go home - eg can access their house and mobilise within house and outdoors
Time Frame
average one month
Title
12-Item Short Form Health Survey (SF-12)
Time Frame
6 months
Title
EuroQOL five dimensions questionnaire (EQ-5D)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admission to The Alfred with an isolated hip fracture and treated with internal fixation, aged 65 or above 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara A Kimmel, B.Physio
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
27456448
Citation
Kimmel LA, Liew SM, Sayer JM, Holland AE. HIP4Hips (High Intensity Physiotherapy for Hip fractures in the acute hospital setting): a randomised controlled trial. Med J Aust. 2016 Jul 18;205(2):73-8. doi: 10.5694/mja16.00091.
Results Reference
derived

Learn more about this trial

High Intensity Physiotherapy for Hip Fractures

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