NCT02088437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

10 months

First QC Date

March 6, 2014

Last Update Submit

December 29, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • modified IOWA Level of Assistance Scale

    Functional score measuring 6 mobility domains

    5 days

Secondary Outcomes (7)

  • length of stay - acute and rehabilitation

    participants will be followed for duration of hospital stay - average one month

  • timed up and go

    5 days

  • Glasgow Outcomes Score -Extended

    6 months

  • discharge destination

    participants will be followed until discharge from the acute hospital - average 10 days

  • physical readiness for discharge

    average one month

  • +2 more secondary outcomes

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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

Other: Usual Care

Intensive physiotherapy

EXPERIMENTAL

additional once daily physiotherapy and once daily allied health assistant intervention

Other: Intensive physiotherapy

Interventions

additional once daily physiotherapy and once daily allied health assistant intervention (equals two more treatments) whilst an inpatient in acute hospital

Intensive physiotherapy

once daily physiotherapy whilst acute hospital inpatient

Usual care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Alfred

Melbourne, Victoria, 3181, Australia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Lara A Kimmel, B.Physio

    The Alfred

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 17, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2015

Study Completion

September 1, 2015

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations