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Trial registered on ANZCTR


Registration number
ACTRN12612000475842
Ethics application status
Approved
Date submitted
11/04/2012
Date registered
1/05/2012
Date last updated
21/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A self-management intervention for promoting exercise and healing rates for adults with venous leg ulcers.
Scientific title
The benefits of a self-management telephone based intervention compared to standard care for promoting exercise and healing rates for adults with venous leg ulcers
Secondary ID [1] 280298 0
Pilot study's Registration ID is ACTRN12611000469910.
Universal Trial Number (UTN)
Trial acronym
Venous leg ulcers and Exercise (VaLUE)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous leg ulcer 286254 0
Condition category
Condition code
Skin 286476 286476 0 0
Dermatological conditions
Physical Medicine / Rehabilitation 286477 286477 0 0
Physiotherapy
Cardiovascular 286478 286478 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12 week home-based unsupervised progressive resistance exercise program that requires no additional equipment for participants. The exercise intervention will be administered by telephone calls from the principal researcher at 4 timepoints (Week 1, 3, 6 and 9) over the duration of the intervention.

Participants have the program individually tailored to suit the strength and endurance of their calf muscle in consultation with the principal researcher who is a RN and Accredited Exercise Physiologist.

The exercise protocol is split into 3 stages
1. Seated heel raises
2. Standing heel raises (both legs)
3. Standing heel raise (one leg)

The participants progress through each stage by the various 4 levels
1. 10 repetitions x 3 sets x 3 times per day
2. 15 repetitions x 3 sets x 3 times per day
3. 20 repetitions x 3 sets x 3 times per day
4. 25 repetitions x 3 sets x 3 times per day

Participants move on to the next level or stage the once they have comfortably completed the current level for at least 3 days or until ready to progress based on their feedback and in consultation with the principal researcher.

The exercise program is in addition to usual care (compression bandaging and wound care)

Particpipants will also be encouraged to walk at least three times per week for 30 minutes if possible (can be broken into 10 minutes three times) in conjunction with the resistance program outlined above. Walking recommendations will be progressive and individualised.
Intervention code [1] 284651 0
Treatment: Other
Intervention code [2] 284780 0
Lifestyle
Intervention code [3] 284781 0
Behaviour
Comparator / control treatment
Usual care - compression bandaging and wound care dressed by the clinical wound nurse in wound clinic at the participating hospital and general exercise advice given from the wound nurses in the clinic. The participants in the usual care group will receive a brochure about the importance of exercise for adults with venous leg ulcers and a pedometer so that they can observe the amount to steps they take on a daily basis.
Control group
Active

Outcomes
Primary outcome [1] 286922 0
Healing rates of venous leg ulcers as measured by healed or not healed, percent reduction in ulcer size, survival analysis and PUSH score
Timepoint [1] 286922 0
Baseline and Week 12 post intervention start date
Secondary outcome [1] 297000 0
Functional outcomes as measured by Tinetti score, range of ankle motion (goniometer)
Timepoint [1] 297000 0
Baseline and Week 12 post intervention start date
Secondary outcome [2] 297001 0
Physical activity as measured objectively by pedometer steps, self-reported through VaLUE questionnaire and adherence to program as collected over the phone
Timepoint [2] 297001 0
Baseline and Week 12 post intervention start date

Eligibility
Key inclusion criteria
Attending either the RBWH wound clinic or QUT Wound Healing Service
Any break in the skin on the lower leg
Diagnosed by the clinician as primarily of venous aetiology
(ABPI > 0.8 < 1.2)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment
Ulcers of non-venous aetiology
Clinical signs of infection
Unable to understand English
Wheelchair bound

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)
The method to be used to implement random allocation will be an envelope system where an independent source will prepare and order the envelopes to ensure that the sequence is concealed until groups are assigned to participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be carried out by an independent source using a computerised statistical package.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
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)
QLD,VIC

Funding & Sponsors
Funding source category [1] 285070 0
University
Name [1] 285070 0
Queensland University of Technology
Address [1] 285070 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Country [1] 285070 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Country
Australia
Secondary sponsor category [1] 283933 0
None
Name [1] 283933 0
Address [1] 283933 0
Country [1] 283933 0
Other collaborator category [1] 260717 0
University
Name [1] 260717 0
Wound healing Community Outreach Service (QUT Wound Clinic)
Address [1] 260717 0
QUT Health Clinics
44 Musk Avenue
Kelvin Grove QLD 4059
Country [1] 260717 0
Australia
Other collaborator category [2] 278062 0
Other Collaborative groups
Name [2] 278062 0
Royal District Nursing Service
RDNS Institute
Address [2] 278062 0
31 Alma Rd
St Kilda
Victoria
3182
Country [2] 278062 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287080 0
University Human Research Ethics Committee
Ethics committee address [1] 287080 0
Research Ethics Unit
Office of Research
Level 4
88 Musk Avenue
Kelvin Grove
QLD
4059
Ethics committee country [1] 287080 0
Australia
Date submitted for ethics approval [1] 287080 0
Approval date [1] 287080 0
15/02/2012
Ethics approval number [1] 287080 0
1200000060
Ethics committee name [2] 291381 0
Royal District Nursing Service Human Research Ethics Committee NMHRC Registered Committee Number EC00349
Ethics committee address [2] 291381 0
31 Alma Rd
St Kilda
Victoria
3182
Ethics committee country [2] 291381 0
Australia
Date submitted for ethics approval [2] 291381 0
Approval date [2] 291381 0
13/08/2013
Ethics approval number [2] 291381 0
1200000060

Summary
Brief summary
The aim of this study is to determine whether a self-management telephone based intervention will promote healing rates, physical activity levels, functional ability and self-efficacy for exercise for adults experiencing venous leg ulceration
Trial website
Trial related presentations / publications
Oral Presentations
O’Brien, J. (2011). The benefits of a self-management telephone based intervention for promoting exercise and healing rates for venous leg ulcer patients. CRC Wound Management Innovation. October 9-10 2011, Gold Coast, Australia. Won best PhD student presentation award

O’Brien, J., Edwards, H., Finlayson, K and Kerr, G. (2012). The meaning of exercise to adults with venous leg ulcers. Australian Wound Management Association (AWMA), 18th – 21st March 2012, Sydney, Australia.

Poster Presentations
O’Brien, J., Edwards, H., Finlayson, K and Kerr, G. (2011). A theory based multi-factorial intervention to increase lower limb exercise and progress in healing for adults with venous leg ulcers. Institute of Health and Biomedical Innovation (IHBI) Inspires Postgraduate student conference. November 2011, Brisbane, Australia.

Accepted abstracts
O’Brien, J., Edwards, H., Finlayson, K and Kerr, G. (2012). Venous Leg Ulcers and Exercise (VaLUE): Theory and Intervention Strategies. Exercise and Sport Science Australia (ESSA), 19th – 21st April, Gold Coast, Australia.

O’Brien, J., Edwards, H., Finlayson, K and Kerr, G. (2012). A Theory-Based Multi-factorial Intervention to Increase Lower Limb Exercise and Progress in Healing For Adults with Venous Leg Ulcers. Sigma Theta Tau International (STTI), July 30 – August 3rd, Brisbane, Australia.

O’Brien, J., Edwards, H., Finlayson, K and Kerr, G. (2012). The overlooked aspect of wound management for adults with venous leg ulcers. World Union of World Healing Societies (WUWHS). Sept 2nd – 6th, Yokohama, Japan.
Public notes

Contacts
Principal investigator
Name 34042 0
Ms Jane O'Brien
Address 34042 0
Queensland University of Technology
60 Musk Ave
Kelvin Grove
4059
Australia
Country 34042 0
Australia
Phone 34042 0
+61731386419
Fax 34042 0
+61731386050
Email 34042 0
j3.obrien@qut.edu.au
Contact person for public queries
Name 17289 0
Ms Jane O'Brien
Address 17289 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Country 17289 0
Australia
Phone 17289 0
+61 7 3138 6419
Fax 17289 0
Email 17289 0
j3.obrien@qut.edu.au
Contact person for scientific queries
Name 8217 0
Miss Jane O'Brien
Address 8217 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Country 8217 0
Australia
Phone 8217 0
+61 7 3138 6419
Fax 8217 0
Email 8217 0
j3.obrien@qut.edu.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