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Trial registered on ANZCTR


Registration number
ACTRN12610000979055
Ethics application status
Approved
Date submitted
11/11/2010
Date registered
12/11/2010
Date last updated
3/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise or advice after ankle fracture
Scientific title
In patients after immobilisation for ankle fracture, is a rehabilitation program consisting of exercises prescribed by physiotherapists more effective than a single session of advice in reducing activity limitation and improving quality-adjusted life years?
Secondary ID [1] 252635 0
Nil
Universal Trial Number (UTN)
Trial acronym
EXACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle fracture 258131 0
Condition category
Condition code
Musculoskeletal 258308 258308 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the treatment (rehabilitation) group will receive the advice intervention (see control treatment for details) plus participate in a program that is designed, monitored and progressed by a physiotherapist. The focus of this program is exercise. Three types of exercises will be prescribed - ankle mobility and strengthening exercises, stepping exercises, and exercises involving weight bearing and balancing on the affected leg. Participants will receive about five treatments (one or two treatment sessions in the first week then one session per week for the next 3 weeks). The first session will take up to 60 minutes and the subsequent sessions will take up to 30 minutes. Participants will be encouraged to perform a carefully structured exercise program at home between physiotherapy appointments, which they will record in an exercise diary.

The exact number of treatments and the timing of discharge are not mandated by the trial protocol. Participants will be discharged by their physiotherapists when they return to their previous level of function, reach a plateau in their progress, or choose to discontinue treatment.

Participants will also receive gait training and ongoing advice about returning to their usual work and leisure activities. Other physiotherapy interventions (e.g. manual therapy and passive stretching) may be administered in conjunction with the exercise program if deemed appropriate.

Where it is deemed appropriate, participants will be instructed to use ice for pain relief and compression and elevation for management of swelling. A compression bandage (i.e. tubigrip) will be provided if required.
Intervention code [1] 257147 0
Rehabilitation
Comparator / control treatment
Participants randomised to the control group will receive the advice intervention. Advice will be provided in a single session in the fracture clinic, after cessation of immobilisation. A physiotherapist will instruct the participant to do exercises that focus on ankle movement in non-weight-bearing positions and will explain how to perform these exercises and how to progressively reduce the use of any walking aids at home. The advice session should be no longer than 10 minutes. The participant will be given a handout that summarises this advice with text and figures.

Where it is deemed appropriate, participants will be instructed to use ice for pain relief and compression and elevation for management of swelling. A compression bandage (i.e. tubigrip) will be provided if required.
Control group
Active

Outcomes
Primary outcome [1] 259158 0
Activity limitation measured by the Lower Extremity Functional Scale
Timepoint [1] 259158 0
Baseline and 1, 3 and 6 months
Primary outcome [2] 259159 0
Quality-adjusted life years measured by the Assessment of Quality of Life (AQoL) instrument
Timepoint [2] 259159 0
Baseline and 1, 3 and 6 months
Secondary outcome [1] 265483 0
Number of days to pain-free walking measured by a diary
Timepoint [1] 265483 0
Daily from baseline until able to walk pain-free for 10 metres at a comfortable pace
Secondary outcome [2] 265484 0
Number of days to return to full pre-fracture work measured by a diary
Timepoint [2] 265484 0
Daily from baseline until able to return to pre-fracture work
Secondary outcome [3] 265485 0
Return to pre-fracture work and leisure measured by a scale from 0% (not participating at all) to 100% (returned to full level)
Timepoint [3] 265485 0
Baseline and 1, 3 and 6 months
Secondary outcome [4] 265486 0
Ankle range of motion measured by the weight-bearing lunge method
Timepoint [4] 265486 0
Baseline and 1 month
Secondary outcome [5] 265487 0
Pain on equal weight-bearing measured by a numerical rating scale from 0 (no pain) to 10 (worst pain you ever had)
Timepoint [5] 265487 0
Baseline and 1, 3 and 6 months
Secondary outcome [6] 265488 0
Pain on stair descent measured by a numerical rating scale from 0 (no pain) to 10 (worst pain you ever had)
Timepoint [6] 265488 0
Baseline and 1, 3 and 6 months
Secondary outcome [7] 265489 0
Unaided walking speed over a 10 m distance measured by a stop watch
Timepoint [7] 265489 0
Baseline and 1 month
Secondary outcome [8] 265490 0
Level of physical activity measured by the International Physical Activity Questionnaire - Short Form
Timepoint [8] 265490 0
Baseline and 1, 3 and 6 months
Secondary outcome [9] 265491 0
Global perceived effect of treatment measured by an 11-point scale from -5 (vastly worse) to +5 (completely recovered)
Timepoint [9] 265491 0
1, 3 and 6 months
Secondary outcome [10] 265492 0
Cost-effectiveness and cost-utility. Costs will be collected in a questionnaire designed for the trial. Effectiveness will be measured by the Lower Extremity Functional Scale (see primary outcome). Utility will be measured by the Assessment of Quality of Life (see primary outcome).
Timepoint [10] 265492 0
1, 3 and 6 months

Eligibility
Key inclusion criteria
1. ankle fracture treated with immobilisation (with or without surgical fixation)
2. immobilisation removed on the day of recruitment
3. approval received from orthopaedic specialist to weight-bear as tolerated or partial weight-bear
4. reduced ankle dorsiflexion range of motion (at least 30 mm less motion compared to the non-fractured leg using the weight-bearing lunge method)
5. experiences at least 2 out of 10 pain in the ankle when up to 50% of body weight is borne through the affected leg
6. completed skeletal growth (i.e. no evidence of epiphyseal cartilage in the tibia in x-rays taken for fracture management)
7. no concurrent pathologies (e.g. symptomatic osteoarthritis, stroke, other fractures) which affect the ability to perform everyday tasks or the measurement procedures used in this study, and
8. provides informed consent.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil in addition to criteria stated under key inclusion criteria

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)
Allocation will be concealed using central randomisation by phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, stratified by site. The randomisation sequence will be generated by an independent statistician in the central randomisation service.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Intention-to-treat analysis
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1481 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 1482 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 1483 0
Ryde Hospital - Eastwood
Recruitment hospital [4] 1484 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 1485 0
Blacktown Hospital - Blacktown
Recruitment hospital [6] 1486 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [7] 1487 0
Mona Vale Hospital - Mona Vale
Recruitment postcode(s) [1] 3264 0
2032
Recruitment postcode(s) [2] 3262 0
2050
Recruitment postcode(s) [3] 3261 0
2065
Recruitment postcode(s) [4] 7320 0
2077 - Hornsby
Recruitment postcode(s) [5] 7321 0
2103 - Mona Vale
Recruitment postcode(s) [6] 3263 0
2122
Recruitment postcode(s) [7] 5084 0
2148

Funding & Sponsors
Funding source category [1] 257600 0
Government body
Name [1] 257600 0
National Health and Medical Research Council
Address [1] 257600 0
Level 1
16 Marcus Clarke Street
CANBERRA ACT 2601
Country [1] 257600 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
PO Box M201
MISSENDEN ROAD NSW 2050
Country
Australia
Secondary sponsor category [1] 256826 0
University
Name [1] 256826 0
The University of Sydney
Address [1] 256826 0
THE UNIVERSITY OF SYDNEY NSW 2006
Country [1] 256826 0
Australia
Other collaborator category [1] 251479 0
Individual
Name [1] 251479 0
Dr Anne Moseley
Address [1] 251479 0
The George Institute for Global Health
PO Box M201
MISSENDEN ROAD NSW 2050
Country [1] 251479 0
Australia
Other collaborator category [2] 251480 0
Individual
Name [2] 251480 0
A/Prof Rob Herbert
Address [2] 251480 0
The George Institute for Global Health
PO Box M201
MISSENDEN ROAD NSW 2050
Country [2] 251480 0
Australia
Other collaborator category [3] 251481 0
Individual
Name [3] 251481 0
A/Prof Marion Haas
Address [3] 251481 0
Centre for Health Economics Research and Evaluation
University of Technology, Sydney
PO Box 123
BROADWAY NSW 2007
Country [3] 251481 0
Australia
Other collaborator category [4] 251482 0
Individual
Name [4] 251482 0
Dr Christine Lin
Address [4] 251482 0
The George Institute for Global Health
PO Box M201
MISSENDEN ROAD NSW 2050
Country [4] 251482 0
Australia
Other collaborator category [5] 251505 0
Individual
Name [5] 251505 0
Ms Deborah Taylor
Address [5] 251505 0
Physiotherapy Department
Royal North Shore Hospital
Pacific Highway
ST LEONARDS NSW 2065
Country [5] 251505 0
Australia
Other collaborator category [6] 251506 0
Individual
Name [6] 251506 0
Ms Trish Evans
Address [6] 251506 0
Physiotherapy Department
Royal North Shore Hospital
Pacific Highway
ST LEONARDS NSW 2065
Country [6] 251506 0
Australia
Other collaborator category [7] 251511 0
Individual
Name [7] 251511 0
Dr Andrew Wines
Address [7] 251511 0
Department of Orthopaedics and Traumatic Surgery
Royal North Shore Hospital
Pacific Highway
ST LEONARDS NSW 2065
Country [7] 251511 0
Australia
Other collaborator category [8] 251512 0
Individual
Name [8] 251512 0
Ms Lisa Gridley
Address [8] 251512 0
Physiotherapy Department
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Country [8] 251512 0
Australia
Other collaborator category [9] 251513 0
Individual
Name [9] 251513 0
Ms Julie Penn
Address [9] 251513 0
Physiotherapy Department
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Country [9] 251513 0
Australia
Other collaborator category [10] 251514 0
Individual
Name [10] 251514 0
Dr Mark Horsley
Address [10] 251514 0
Orthopaedic Department
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Country [10] 251514 0
Australia
Other collaborator category [11] 251515 0
Individual
Name [11] 251515 0
Ms Julia Cameron
Address [11] 251515 0
Physiotherapy Department
Ryde Hospital
Denistone Road
EASTWOOD NSW 2122
Country [11] 251515 0
Australia
Other collaborator category [12] 251516 0
Individual
Name [12] 251516 0
Ms Judy Chen
Address [12] 251516 0
Physiotherapy Department
Prince of Wales Hospital
Barker Street
RANDWICK NSW 2032
Country [12] 251516 0
Australia
Other collaborator category [13] 251517 0
Individual
Name [13] 251517 0
Ms Karen Lee
Address [13] 251517 0
Physiotherapy Department
Prince of Wales Hospital
Barker Street
RANDWICK NSW 2032
Country [13] 251517 0
Australia
Other collaborator category [14] 260625 0
Individual
Name [14] 260625 0
Ms Vanessa Abbott
Address [14] 260625 0
Blacktown Hospital
Blacktown Road
BLACKTOWN 2148
Country [14] 260625 0
Australia
Other collaborator category [15] 260626 0
Individual
Name [15] 260626 0
Luke Elias
Address [15] 260626 0
Mt Druitt Hospital
Railway St,
MT DRUITT 2770
Country [15] 260626 0
Australia
Other collaborator category [16] 260627 0
Individual
Name [16] 260627 0
Bijoy Thomas
Address [16] 260627 0
Blacktown Hospital
Central West Orthopaedics
Suite 304, 30 Campbell St
BLACTOWN 2148
Country [16] 260627 0
Australia
Other collaborator category [17] 277603 0
Individual
Name [17] 277603 0
Ian Jordan
Address [17] 277603 0
Hornsby Kuringai Hospital
Palmerston Road
Hornsby NSW 2077
Country [17] 277603 0
Australia
Other collaborator category [18] 277604 0
Individual
Name [18] 277604 0
Michelle Appleby
Address [18] 277604 0
Mona Vale Hospital
Coronation Street
Mona Vale NSW 2103
Country [18] 277604 0
Australia
Other collaborator category [19] 277605 0
Individual
Name [19] 277605 0
Tyson Russell
Address [19] 277605 0
Mona Vale Hospital
Coronation Street
Mona Vale NSW 2103
Country [19] 277605 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259701 0
Northern Sydney Central Coast Area Health Service Human Research Ethics Committee (Hawkesbury)
Ethics committee address [1] 259701 0
The Research Office
Level 2, Building 51
Royal North Shore Hospital
Pacific Highway
ST LEONARDS NSW 2065
Ethics committee country [1] 259701 0
Australia
Date submitted for ethics approval [1] 259701 0
Approval date [1] 259701 0
26/08/2010
Ethics approval number [1] 259701 0
1006234M

Summary
Brief summary
This study will determine if rehabilitation programs for people with ankle pain and stiffness following immobilisation for ankle fracture produce clinically worthwhile effects and are cost-effective.
Trial website
Trial related presentations / publications
Trial results have been published:
Moseley AM, Beckenkamp PR, Haas M, Herbert RD, Lin C-WC. (2015). Rehabilitation after immobilization for ankle fracture: The EXACT randomized clinical trial. JAMA 314,1376-1385.

The trial protocol was published in 2011:
Beckenkamp PR, Lin C-WC, Herbert RD, Haas M, Khera K, Moseley AM. (2011). EXACT: EXercise or Advice after ankle fraCTure. Design of a randomised controlled trial. BMC Musculoskeletal Disorders 12,148.
Public notes

Contacts
Principal investigator
Name 31608 0
Dr Anne Moseley
Address 31608 0
The George Institute for Global Health PO Box M201 MISSENDEN ROAD NSW 2050
Country 31608 0
Australia
Phone 31608 0
61 2 9657 3000
Fax 31608 0
Email 31608 0
amoseley@georgeinstitute.org.au
Contact person for public queries
Name 14855 0
Dr Anne Moseley
Address 14855 0
The George Institute for Global Health
PO Box M201
MISSENDEN ROAD NSW 2050
Country 14855 0
Australia
Phone 14855 0
+61 2 9657 3000
Fax 14855 0
+61 2 9657 0301
Email 14855 0
amoseley@georgeinstitute.org.au
Contact person for scientific queries
Name 5783 0
Dr Anne Moseley
Address 5783 0
The George Institute for Global Health
PO Box M201
MISSENDEN ROAD NSW 2050
Country 5783 0
Australia
Phone 5783 0
+61 2 9657 3000
Fax 5783 0
+61 2 9657 0301
Email 5783 0
amoseley@georgeinstitute.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary