Clinical trial NCT00222300: A Targeted Strengthening Program Following Total Hip Replacement.
Official title: A Targeted Strengthening Program Following Total Hip Replacement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Joint Replacement
Keywords: Total hip replacement
Strength training
Gait analysis
Lead sponsor: University of Melbourne
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total Hip Replacement (THR) is a common surgical procedure performed in people with hip osteoarthritis and appears to be effective in relieving pain and improving function. However significant wasting and weakness of the hip and knee muscles persists post-operatively. Although relief of pain and improvement of function are important outcomes following THR, weakness of the hip and knee muscles reduces a person's ability to manage stairs, slopes, public transport and results in persistent gait abnormalities. Since lower limb weakness is one of the risk factors for falls, it is important that patients undergo a strengthening program post-operatively. The hypothesis is that lower limb strength and function will be better in patients who undergo a strengthening program post-operatively than in those who have usual care.

Detailed description: Total Hip Replacement (THR) is a common surgical procedure performed in people with hip osteoarthritis and appears to be effective in relieving pain and improving function. However significant quadriceps atrophy and weakness persist post-operatively. Although relief of pain and improvement of function are important outcomes following THR, weakness of the hip and knee muscles reduces a person's ability to manage stairs, slopes, public transport and results in persistent gait abnormalities. Since lower limb weakness is one of the risk factors for falls, it is important that this is appropriately addressed.

The study examines the effect of an eight-week task-specific strengthening program on lower limb function in patients following THR in a randomized controlled trial. The experimental program is being conducted as a circuit in a gymnasium environment. Changes on specific measures of physical function of patients in the Experimental Group will be compared with those of patients in a Control Group who will continue with the standard care program provided at Austin Health.

Outcome measures include:lower limb muscle strength using a step test, pain, stiffness, and function as reported on the WOMAC questionnaire, quality of life using the AQoL questionnaire, the Timed Up-and-Go test. Walking tests will also be conducted. These include:

1. Walking pattern, recorded on an instrumented mat
2. Walking endurance measured by the 6-minute walk test.
3. Analysis of hip joint torques using 3-D motion analysis.

Eligibility criteria: Inclusion Criteria:

* primary uncomplicated total hip joint replacement 6-8 weeks prior to enrolment.
* able to walk 45m independently with or without walking aid.
* able to comprehend instructions
* prior joint replacement on the other side at least 12 months previously

Exclusion Criteria:

* unable to fully weight-bear on affected limb
* pre-existing neurological or orthopaedic condition affecting gait
* revision surgery
* post-operative complications, e.g. wound infection
* uncontrolled systemic disease

Primary outcomes:
measure: Lower limb strength using a step test
Secondary outcomes:
measure: Pain, stiffness and function using the WOMAC questionnaire.
measure: Function using the Timed Up-and-Go Test.
measure: Quality of life using the AQoL
measure: Spatiotemporal measures of walking using an instrumented mat.
measure: Hip joint torques using 3-D motion analysis.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Mary P Galea, PhD
role: PRINCIPAL_INVESTIGATOR
References: