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Trial registered on ANZCTR


Registration number
ACTRN12611000469910
Ethics application status
Approved
Date submitted
25/02/2011
Date registered
6/05/2011
Date last updated
8/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A home-based progressive resistance exercise program assessing healing rates for patients with venous leg ulcers.
Scientific title
A 12 week home-based progressive resistance exercise program compared to standard care to assess healing rates for patients with venous leg ulcers.
Secondary ID [1] 262124 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous leg ulcer 261249 0
Condition category
Condition code
Skin 259397 259397 0 0
Dermatological conditions
Physical Medicine / Rehabilitation 259398 259398 0 0
Physiotherapy
Cardiovascular 259399 259399 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A home-based unsupervised progressive resistance exercise program that requires no additional equipment for participants.

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 Exercise Scientist.

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 3days 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)
Intervention code [1] 258110 0
Rehabilitation
Comparator / control treatment
Usual care - compression bandaging and wound care dressed by the clinical wound nurse in wound clinic at the participating hospital
Control group
Active

Outcomes
Primary outcome [1] 262211 0
Healing rates of venous leg ulcers as measured by healed or not healed, percent reduction in ulcer size and PUSH score
Timepoint [1] 262211 0
Baseline, week 6 and Week 12 post intervention start date
Secondary outcome [1] 273338 0
Calf Muscle pump function as measured by Air Plethysmography - Ejection fraction, Residual Volume fraction and venous filling Index
Timepoint [1] 273338 0
Baseline and Week 12 post intervention start date
Secondary outcome [2] 273339 0
Fitness parameters - calf muscle enduurance (maximum number of heel raises) calf muscle strength (myometer) and ankle range of motion (goniometer)
Timepoint [2] 273339 0
Baseline, week 6 and week 12 post intervention start date

Eligibility
Key inclusion criteria
Any break in the skin on the lower leg that had been present for six weeks or more
No other causative aetiology being present
Appearing clinically venous
An ABPI of greater than 0.8, but less than 1.3.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical signs of cellulitis

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



Intervention assignment
Parallel
Other design features
Phase
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)

Funding & Sponsors
Funding source category [1] 258565 0
University
Name [1] 258565 0
Queensland University of Technology
Address [1] 258565 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Australia
Country [1] 258565 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
Australia
Country
Australia
Secondary sponsor category [1] 257706 0
None
Name [1] 257706 0
Address [1] 257706 0
Country [1] 257706 0
Other collaborator category [1] 251833 0
Hospital
Name [1] 251833 0
Princess Alexandra Hospital
Address [1] 251833 0
Ipswich Road, Woolloongabba
Queensland, 4102
Australia
Country [1] 251833 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260549 0
Human Research Ethics Committees of the Princess Alexandra Hospital
Ethics committee address [1] 260549 0
199 Ipswich Road
Woolloongabba, Brisbane
Queensland, 4102, AUSTRALIA
Ethics committee country [1] 260549 0
Australia
Date submitted for ethics approval [1] 260549 0
16/11/2007
Approval date [1] 260549 0
07/02/2008
Ethics approval number [1] 260549 0
Protocol No: 2007/210
Ethics committee name [2] 260550 0
Princess Alexandra Hospital Human Resouces Ethics Committee
Ethics committee address [2] 260550 0
Level 2, Building 35, Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba, Brisbane, Queensland, 4102, AUSTRALIA
Ethics committee country [2] 260550 0
Australia
Date submitted for ethics approval [2] 260550 0
16/11/2007
Approval date [2] 260550 0
07/02/2008
Ethics approval number [2] 260550 0
2007/210

Summary
Brief summary
The aim of this pilot study was to establish if a home-based progressive resistance exercise program was feasible and then determine if there was clinical improvement in the healing rates of venous leg ulcers as a result of the intervention. Secondary aims were to examine if participation in the home-based program improved calf muscle pump function or the physical fitness parameters measured as part of this pilot study.
Trial website
Trial related presentations / publications
O’Brien, J., Edwards, H., Stewart, I. (2011); A pilot study assessing the feasibility of a home-based progressive resistance exercise program and trend toward healing rates for patients with venous leg ulcers. Wounds International Conference. February 2011, Cape Town, South Africa.

O’Brien, J (2010); Pilot study results from a home-based progressive resistance exercise program and healing rates of patients with venous leg ulcers?. Institute of Health and Biomedical Innovation (IHBI) Inspires Postgraduate student conference. November 2010, Gold Coast, Queensland.

O’Brien, J (2010); Does a home based exercise program promote healing rates of patients with venous leg ulcers? A pilot study. Final Seminar. September 2010, Queensland University of Tecnology, Brisbane, Queensland.
Public notes

Contacts
Principal investigator
Name 32271 0
Address 32271 0
Country 32271 0
Phone 32271 0
Fax 32271 0
Email 32271 0
Contact person for public queries
Name 15518 0
Jane O'Brien
Address 15518 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Australia
Country 15518 0
Australia
Phone 15518 0
+61 7 3138 6419
Fax 15518 0
Email 15518 0
j3.obrien@qut.edu.au
Contact person for scientific queries
Name 6446 0
Jane O'Brien
Address 6446 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Australia
Country 6446 0
Australia
Phone 6446 0
+61 7 3138 6419
Fax 6446 0
Email 6446 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