High Intensity Physiotherapy for Hip Fractures

Hip Fractures Clinical Trial

— HIP4hips  

Official title:

High Intensity Physiotherapy for Hip Fractures in the Acute Hospital Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088437
• Other study ID #: 32/14
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: December 29, 2015
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: The Alfred
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: September 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

Other:
• Intensive physiotherapy
additional once daily physiotherapy and once daily allied health assistant intervention (equals two more treatments) whilst an inpatient in acute hospital
• Usual Care
once daily physiotherapy whilst acute hospital inpatient

Locations

Country	Name	City	State
Australia	The Alfred	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified IOWA Level of Assistance Scale	Functional score measuring 6 mobility domains	5 days	No
Secondary	length of stay - acute and rehabilitation	the length of acute hospital stay and rehabilitation stay - until discharge home or to a long term facility	participants will be followed for duration of hospital stay - average one month	No
Secondary	timed up and go		5 days	No
Secondary	Glasgow Outcomes Score -Extended		6 months	No
Secondary	discharge destination	discharge destination from the acute hospital - options include: home, fast stream rehabilitation, slow stream rehabilitation, long term facility	participants will be followed until discharge from the acute hospital - average 10 days	No
Secondary	physical readiness for discharge	when a patient is deemed physically ready go home - eg can access their house and mobilise within house and outdoors	average one month	No
Secondary	12-Item Short Form Health Survey (SF-12)		6 months	No
Secondary	EuroQOL five dimensions questionnaire (EQ-5D)		6 months	No