Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000167965
Ethics application status
Approved
Date submitted
23/07/2010
Date registered
11/02/2011
Date last updated
11/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rehabilitation after elective total hip replacement.
Scientific title
Comparison of structured physiotherapy rehabilitation with an unsupervised home exercise program after elective total hip replacement surgery for optimal patient recovery.
Secondary ID [1] 252286 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total hip replacement 257761 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257935 257935 0 0
Physiotherapy
Musculoskeletal 259014 259014 0 0
Osteoarthritis
Musculoskeletal 259015 259015 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 groups:

Group 2: Independent home exercise program (reliant on pt compliance)
This group is designed to investigate whether physiotherapy led rehabiltation is required post THR.
Standard post THR ex program provided to all patients, instructed to continue these 3x daily independently as per in hospital ad to continue on discharge from hospital; exs focus on lower limb ROM & strengthing.
Patients choose to follow instructions on ex sheet which are as follows (time frame for completion of each session is patient dependent; 6 exs min x10 reps till 3 months then 8 exs recommended):
- You must exercise at least 3 times daily. Repeat each exercise slowly at least 5-10 times.
-Exercises 3 to 8 should be continued following discharge from hospital. Exercise 9-10 can be commenced at 3 months.
The exercises are indicated on the sheet to continue till 3months and then an additional two exercises are shown that are able to be commenced after 3 months but their is no emphasis for how long the program needs to continue post 3 months.
The re assessment intervals do continue till 6 months ( 5, 12 & 26 wks as documented)
Intervention code [1] 256823 0
Rehabilitation
Comparator / control treatment
Group 1: Supervised exercise class (Standard care)
Provided in group setting led by physiotherapist
Circuit program 60min involving lower limb strengthening, ROM & gait retraining stations
Offered 2x wk/4wks,to commence by next available session after hospital discharge
Max class participants 12
Control group
Active

Outcomes
Primary outcome [1] 258793 0
Quality of Life by the Short form 36 questionnaire (SF36)
Timepoint [1] 258793 0
Pre operatively, 5, 12 , & 26 weeks post operatively
Primary outcome [2] 258805 0
Self reported Hip function by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Timepoint [2] 258805 0
Pre operatively, 5, 12, & 26 weeks post operatively
Secondary outcome [1] 264868 0
Mobility by the Timed Up and Go Test (TUG)
Timepoint [1] 264868 0
Pre operatively, 5, 12, & 26 weeks post operatively

Eligibility
Key inclusion criteria
1. Have had an elective total hip replacement.
2. Be able to full weight bear post operatively/ weight bear as tolerated.
3. Reside within the normal service provision area post operatively.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Total hip replacement surgery for metastatic disease, pathological fractures, infection or acute trauma.
2. Revision total hip replacement surgery.
3. Inability to provide informed consent due to poor understanding of explanation and unable to follow independently a home exercise program.
4. University of California, Los Angeles (UCLA) activity level < 2 pre operatively.
5. Persons under the age of 18.
6. Inabliity to provide informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be identified at their pre admission clinic appointment if they want to participate by the interviewing nurse.
The senior orthopaedic physiotherapist will then be available to explain the study, recruit the patient and complete consent. Following consent participants will be asked to complete several forms and receive the patient information sheet.
Following their surgery, in hospital physiotherapy and care will proceed according to the standard protocols.
When the participant is ready for discharge they will be assigned to intervention group 1 or 2 by opening of a randomisation envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by permuted blocks to assist with maintaining equivalent sample size in both groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257297 0
University
Name [1] 257297 0
Australian National University
Country [1] 257297 0
Australia
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
Trauma and Orthopaedic Research Unit
Building 6, Level 1
Canberra Hospital
Garran ACT 2605
Country
Australia
Secondary sponsor category [1] 256537 0
University
Name [1] 256537 0
Australian National University
Address [1] 256537 0
Canberra, ACT 2600
Country [1] 256537 0
Australia
Other collaborator category [1] 251389 0
Hospital
Name [1] 251389 0
The Canberra Hospital - Physiotherapy Department
Address [1] 251389 0
Physiotherapy Department
Canberra Hospital
PO Box 11
Woden ACT 2606
Country [1] 251389 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259318 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 259318 0
Ethics committee country [1] 259318 0
Australia
Date submitted for ethics approval [1] 259318 0
Approval date [1] 259318 0
10/02/2010
Ethics approval number [1] 259318 0
ETH.8/09.795
Ethics committee name [2] 259319 0
Australian National University Human Ethics Committee
Ethics committee address [2] 259319 0
Ethics committee country [2] 259319 0
Australia
Date submitted for ethics approval [2] 259319 0
Approval date [2] 259319 0
28/05/2010
Ethics approval number [2] 259319 0
2010/036

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31401 0
Address 31401 0
Country 31401 0
Phone 31401 0
Fax 31401 0
Email 31401 0
Contact person for public queries
Name 14648 0
Corinne Coulter
Address 14648 0
Physiotherapy Department
Canberra Hospital
PO Box 11
Woden ACT 2606
Country 14648 0
Australia
Phone 14648 0
+61 2 62442154
Fax 14648 0
Email 14648 0
[email protected]
Contact person for scientific queries
Name 5576 0
Dr Jennie Scarvell
Address 5576 0
Trauma and Orthopaedic Research Unit
Clinical Research Coordinator
Buidling 6, Level 1
Canberra Hospital
PO Box 11
Woden ACT 2606
Country 5576 0
Australia
Phone 5576 0
+61 2 6244 3701
Fax 5576 0
+61 2 6201 2157
Email 5576 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSupervised and Independent Post-Discharge Rehabilitation Did Not Differ for Improving Pain and Function After Unilateral Total Hip Replacement.2018https://dx.doi.org/10.2106/JBJS.18.00633
N.B. These documents automatically identified may not have been verified by the study sponsor.