A Targeted Strengthening Program Following Total Hip Replacement.

Total Hip Joint Replacement Clinical Trial

Official title:

A Targeted Strengthening Program Following Total Hip Replacement.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222300
• Other study ID #: H2002/01532
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: August 7, 2006
• Start date: May 2003
• Est. completion date: December 2005

Study information

• Verified date: October 2003
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Hip Joint Replacement

Intervention

Behavioral:
• Strength training program

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower limb strength using a step test
Secondary	Pain, stiffness and function using the WOMAC questionnaire.
Secondary	Function using the Timed Up-and-Go Test.
Secondary	Quality of life using the AQoL
Secondary	Spatiotemporal measures of walking using an instrumented mat.
Secondary	Hip joint torques using 3-D motion analysis.