Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000118808
Ethics application status
Approved
Date submitted
3/01/2012
Date registered
24/01/2012
Date last updated
4/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Does exercise following distal radius fracture improve activity? A multi-centre randomised controlled trial
Scientific title
Is a program of exercise and advice compared to advice, more effective in improving activity on the Patient Rated Wrist Evaluation questionnaire following a distal radius fracture?
Secondary ID [1] 273612 0
Nil
Universal Trial Number (UTN)
U1111-1126-4511
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Distal Radius Fracture 285407 0
Condition category
Condition code
Physical Medicine / Rehabilitation 285587 285587 0 0
Physiotherapy
Injuries and Accidents 285716 285716 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental group will receive professional advice plus a progessive exercise program in three standard consultations (approximately 20-30 minutes) held in Weeks 7, 9 and 11 (from time of injury). In consultation 1 (Week 7), patients will receive advice regarding fracture healing, pain, swelling and performance of daily light tasks. In addition, patients will commence a light exercise program to include active range of movement exercises of the hand/wrist/elbow and shoulder as well as isometric strengthening exercises of the wrist/forearm. In consultation 2 (Week 9), patients will receive advice again about fracture healing, pain, swelling and performance of daily tasks. The exercise program will be progressed to include strengthening exercises of the hand and wrist (including grip strength). In consultation 3 (Week 11), patients will receive advice about returning to more difficult functional tasks and the exercise program will be progressed to include heavier loads. Patients will also receive advice to progress and continue the exercises for one more week (this will equate to 12 weeks from time of injury). Patients will be advised to complete the exercises three times per day with sets varying from one to three depending on the exercise and progression.
Intervention code [1] 283895 0
Rehabilitation
Comparator / control treatment
The control group will receive the same program of professional advice that the experimental group received. This means they will receive three standard physiotherapy consultations in weeks 7, 9 and 11 which will last between 20-30 minutes. In consultation 1 (Week 7), patients will receive advice regarding fracture healing, pain, swelling and performance of daily light tasks. In consultation 2 (Week 9), patients will receive advice again about fracture healing, pain, swelling and performance of daily tasks. In consultation 3 (Week 11), patients will receive advice about returning to more difficult functional tasks.
Control group
Active

Outcomes
Primary outcome [1] 286152 0
Primary Outcome Measure 1: Activity limitations as assessed by the activity specific section on the Patient Rated Wrist Evaluation questionnaire.
Timepoint [1] 286152 0
Timepoint 1: baseline = 0 weeks (time of recuitment = 5-6 weeks from time of injury)
Timepoint 2: following the intervention = 6 weeks
Timepoint 3: follow up = 18 weeks (24 weeks from time of injury)
Primary outcome [2] 286153 0
Primary Outcome Measure 2: The 19 item QuickDASH questionnaire will be used to measure disability of the affected upper limb
Timepoint [2] 286153 0
Timepoint 1: baseline = 0 weeks (time of recuitment = 5-6 weeks from time of injury)
Timepoint 2: following the intervention = 6 weeks
Timepoint 3: follow up = 18 weeks (24 weeks from time of injury)
Primary outcome [3] 286154 0
Primary Outcome Measure 3: Accelerometers will be used to quantify the extent of arm usage (the amount and intensity of arm activity) of participatis using the mean total activity over seven consecutive days
Timepoint [3] 286154 0
Timepoint 1: baseline = 0 weeks (time of recuitment = 5-6 weeks from time of injury)
Timepoint 2: following the intervention = 6 weeks
Timepoint 3: follow up = 18 weeks (24 weeks from time of injury)
Secondary outcome [1] 295250 0
Secondary Outcome 1: Wrist flexion, extension and supination range of movement will be measured using a goniometer and following standard administering procedures as outlined by the American Society of Hand Therapists
Timepoint [1] 295250 0
Timepoint 1: baseline = 0 weeks (time of recuitment = 5-6 weeks from time of injury)
Timepoint 2: following the intervention = 6 weeks
Timepoint 3: follow up = 18 weeks (24 weeks from time of injury)
Secondary outcome [2] 295251 0
Secondary Outcome 2: Isometric grip strength will be measured in kilograms using a calibrated Jamar dynamometer on setting 2 to ensure maximal grip strength and with the elbow flexed to 90 degrees
Timepoint [2] 295251 0
Timepoint 1: baseline = 0 weeks (time of recuitment = 5-6 weeks from time of injury)
Timepoint 2: following the intervention = 6 weeks
Timepoint 3: follow up = 18 weeks (24 weeks from time of injury)
Secondary outcome [3] 295252 0
Secondary Outcome 3: Pain will be measured using the 5-item pain specific section of the Patient Rated Wrist Evaluation questionnaire
Timepoint [3] 295252 0
Timepoint 1: baseline = 0 weeks (time of recuitment = 5-6 weeks from time of injury)
Timepoint 2: following the intervention = 6 weeks
Timepoint 3: follow up = 18 weeks (24 weeks from time of injury)
Secondary outcome [4] 295253 0
Secondary Outcome 4: Adherence to the home based exercise program will be assessed using home exercise diaries. Participants will be required to make daily entries about the number of sessions they did and the number of exericses per session. To determine home exericse adherence rates, the amount of exericse performed will be compared to the amount of exercise prescribed
Timepoint [4] 295253 0
Timepoint 1: baseline = 0 weeks (time of recuitment = 5-6 weeks from time of injury)
Timepoint 2: following the intervention = 6 weeks
Timepoint 3: follow up = 18 weeks (24 weeks from time of injury)

Eligibility
Key inclusion criteria
- All adults referred to the outpatient physiotherapy departments at the recruited health agencies following a distal radius fracture and were managed in a cast
- Able to follow simple written and verbal English instructions so that the participant can complete the prescribed exercise program and provide consent
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any pre-existing inflammatory joint condition, or signs and symptoms of complex regional pain syndrome, or previous wrist fracture on the affected side
- Bilateral wrist fractures or any other injury (such as other fracture or recent surgery) to the affected limb
- Any distal radius fracture that has been managed with internal or external fixation

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 adults referred to the physiotherapy outpatient department at the participating health agencies for rehabilitation following a distal radius fracture. Potential participants, as recognised by the referral made to the physitoherapy department, will receive a participant information flyer from the physiotherapy department. All individuals who have been provided with an information flyer will be invited to speak with a member of the research team for more information and possible recuitment into the study. Appointments will be scheduled for interested participants and a member of the research team to explain the clincial trial verbally and in written form. They will at this point be invited to participate in the study. Patients will be randomised at their initial consultation with the treating physiotherapist. Assignments to either control or experimental group will be sealed in sequentially numbered opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocks, stratified for site and hand dominance, will be prepared to ensure that both experimental and control groups will be approximately the same. Permuted blocks will be generated from a random-number table. Generation of the block allocation system will be completed by a researcher who will have no involvement in patient recruitment, assessment or treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/07/2012
Actual
26/07/2012
Date of last participant enrolment
Anticipated
Actual
11/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4779 0
3076
Recruitment postcode(s) [2] 4780 0
3135

Funding & Sponsors
Funding source category [1] 284475 0
Charities/Societies/Foundations
Name [1] 284475 0
The Physiotherapy Research Foundation
Country [1] 284475 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Bundoora, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 283401 0
None
Name [1] 283401 0
Address [1] 283401 0
Country [1] 283401 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286348 0
Northern Health Human Research and Ethics Committee
Ethics committee address [1] 286348 0
The Northern Hospital
185 Cooper Street
Epping
Victoria
3076
Ethics committee country [1] 286348 0
Australia
Date submitted for ethics approval [1] 286348 0
26/10/2011
Approval date [1] 286348 0
26/06/2012
Ethics approval number [1] 286348 0
Ethics committee name [2] 286349 0
Eastern Health Human Research and Ethics Committee
Ethics committee address [2] 286349 0
Level 2
5 Arnold Street
Box Hill
Victoria
3128
Ethics committee country [2] 286349 0
Australia
Date submitted for ethics approval [2] 286349 0
16/01/2012
Approval date [2] 286349 0
28/03/2012
Ethics approval number [2] 286349 0
Ethics committee name [3] 286406 0
La Trobe University
Ethics committee address [3] 286406 0
Faculty of Health Sciences
Level 2
Health Sciences Buidling 2
La Trobe University
Bundoora
Victoria
3086
Ethics committee country [3] 286406 0
Australia
Date submitted for ethics approval [3] 286406 0
01/02/2012
Approval date [3] 286406 0
30/04/2012
Ethics approval number [3] 286406 0

Summary
Brief summary
The aim of this study is to find out if people following a distal radal fracture recover better if they receive a progressive exercise program. Our hypothesis is that a progressive exercise program imiplemented during the rehabilitation phase following a distal radius fracture in addition to advice will achieve better recovery of upper limb activity and functional activities than advice alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33539 0
Ms Andrea Bruder
Address 33539 0
Department of Physiotherapy
La Trobe University
Bundoora
Victoria
3086
Country 33539 0
Australia
Phone 33539 0
+61 3 94795853
Fax 33539 0
Email 33539 0
[email protected]
Contact person for public queries
Name 16786 0
Ms Andrea Bruder
Address 16786 0
La Trobe University
Department of Physiotherapy
Bundoora
Victoria
3086
Country 16786 0
Australia
Phone 16786 0
+61394795853
Fax 16786 0
+61394795768
Email 16786 0
[email protected]
Contact person for scientific queries
Name 7714 0
Ms Andrea Bruder
Address 7714 0
La Trobe University
Department of Physiotherapy
Bundoora
Victoria
3086
Country 7714 0
Australia
Phone 7714 0
+61394795853
Fax 7714 0
+61394795768
Email 7714 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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