Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000491561
Ethics application status
Approved
Date submitted
8/11/2006
Date registered
28/11/2006
Date last updated
3/11/2020
Date data sharing statement initially provided
3/11/2020
Date results information initially provided
3/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Progressive resistant exercise programme for healing venous leg ulcers
Scientific title
A pilot randomised controlled trial of home-based progressive resistant exercises and usual care compared to usual care alone for patients with venous leg ulcers
Secondary ID [1] 286783 0
Health Research Council of New Zealand 06/533
Universal Trial Number (UTN)
Trial acronym
PREPARE Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous leg ulceration 1469 0
Condition category
Condition code
Cardiovascular 1565 1565 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: 12 week programme of three sets of heel raises every alternate day in addition to compression therapy. The maximum number of heel raises will be assessed at baseline, 3 weeks, 6 weeks and 9 weeks, with the number of heel raises per set to be set at 80% of the maximum (up to a maximum of 10) raises per set. Each set of heel raises will take approximately 1-2 minutes and the participant will complete 3 sets.

Both intervention and control participants will receive compression therapy, either compression bandages or compression stockings. The choice of compression will be determined by participant and/or clinical preference.
Intervention code [1] 1434 0
Treatment: Other
Comparator / control treatment
Control: Usual care - normal exercise advice given to people with venous ulcers.
Control group
Active

Outcomes
Primary outcome [1] 2160 0
Calf muscle function at 12 weeks measured by changes from baseline in ejection fraction and residual volume fraction determined by air plethysmography
Timepoint [1] 2160 0
Calf muscle function measured at baseline and 12 weeks.
Secondary outcome [1] 3772 0
Acceptability and tolerability of exercise intervention as measured by compliance with exercise prescription.
Timepoint [1] 3772 0
at 3, 6, 9 and 12 weeks
Secondary outcome [2] 3773 0
Withdrawals and adverse events
Timepoint [2] 3773 0
at 12 weeks
Secondary outcome [3] 3774 0
Proportion healed
Timepoint [3] 3774 0
at 12 weeks
Secondary outcome [4] 3775 0
Time to healing
Timepoint [4] 3775 0
at 12 weeks.

Eligibility
Key inclusion criteria
Community-based diagnosis of venous ulceration based on case definition of clinical presentation, absence of other causative diseases and ankle-brachial index greater than 0.8; able to be treated with compression therapy; able to give informed consent; and able to perform at least one heel raise.mmunity-based diagnosis of venous ulceration based on case definition of clinical presentation, absence of other causative diseases and ankle-brachial index greater than 0.8; able to be treated with compression therapy; able to give informed consent; and able to perform at least one heel raise.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of rheumatoid arthritis; exercise intervention contraindicated by unstable medical condition such as heart failure.

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)
Sealed sequential opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation using permuted blocks. Stratification will be by a score on a three level prognostic index (Margolis index) that measures likelihood of healing with 24 weeks of compression therapy.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a pilot study testing the feasibility of procedures for a larger trial, we did not determine the sample size using a power calculation. We proposed to seek 50 participants to test our procedures in order to provide data for a sample size calculation for a main trial. All data analyses were carried out on an intention-to-treat basis. Continuous data was assessed for normality and will be analysed using either parametric or nonparametric statistics, as appropriate. All tests were two-tailed with significance set at 5%. The difference between treatment group means in calf muscle function (ejection fraction and residual volume fractions) from baseline to 12 weeks were analysed using linear regression. Simple incidence rates, relative risks and 95% confidence intervals were obtained for binary variables, such as proportion healed and incidence of adverse events. Time to healing was analysed using Cox proportional hazards regression modelling. Prior to undertaking any Cox regression modelling, the effectiveness of the interventions on time to healing were analysed using Kaplan-Meier curves to compare the differences between the two groups using the log rank test. The Statistical Analysis Plan is available on request.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2006
Actual
11/12/2006
Date of last participant enrolment
Anticipated
Actual
29/06/2007
Date of last data collection
Anticipated
Actual
21/09/2007
Sample size
Target
50
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 415 0
New Zealand
State/province [1] 415 0
Auckland

Funding & Sponsors
Funding source category [1] 1705 0
Government body
Name [1] 1705 0
Health Research Council of New Zealand
Country [1] 1705 0
New Zealand
Primary sponsor type
Individual
Name
Principal investigator (Andrew Jull)
Address
National Institute for Health Innovation, University of Auckland, Private Bag 92019, Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 1506 0
None
Name [1] 1506 0
None
Address [1] 1506 0
Country [1] 1506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3163 0
Northern Regional Ethics Committee Y
Ethics committee address [1] 3163 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 3163 0
New Zealand
Date submitted for ethics approval [1] 3163 0
Approval date [1] 3163 0
20/11/2006
Ethics approval number [1] 3163 0
NTY/06/10/092

Summary
Brief summary
Leg ulcers are costly, debilitating condition with few effective treatments. Compression bandaging helps healing, but about 4 out of every 10 people with a leg ulcer remain unhealed after 3 months. Recurrence occurs in up to 70% of people. Calf muscle function is poorer in people with venous leg ulcers than in people without such ulcers. Simple, easy and quickly completed home-based exercises can improve calf muscle function in people with venous ulcers, but it is not known what effect they have on ulcer healing. Current treatment for venous ulcers is compression bandaging. Participants in this pilot study will be randomised to receive the exercises + compression, or compression alone. The exercises are heel raises, and progress will be assessed every 3 weeks for the 12 week treatment period. This pilot study aims to test the acceptability, tolerability and efficacy of the home-based exercises on calf muscle function and provide information for the feasibility of a larger trial.
Trial website
Trial related presentations / publications
Jull A, Parag V, Walker N, Maddison R, Kerse N, Johns T. The PREPARE Pilot RCT of home-based progressive resistance exercises for venous leg ulcers. J Wound Care 2009;18(12):497-503.
Public notes

Contacts
Principal investigator
Name 27368 0
Prof Andrew Jull
Address 27368 0
School of Nursing
University of Auckland
Private Bag 92019
Auckland 1142
Country 27368 0
New Zealand
Phone 27368 0
+64 9 923 4259
Fax 27368 0
Email 27368 0
[email protected]
Contact person for public queries
Name 10623 0
Prof Andrew Jull
Address 10623 0
School of Nursing
University of Auckland
Private Bag 92019
Auckland 1142
Country 10623 0
New Zealand
Phone 10623 0
+64 9 923 4259
Fax 10623 0
Nil
Email 10623 0
[email protected]
Contact person for scientific queries
Name 1551 0
Prof Andrew Jull
Address 1551 0
School of Nursing
University of Auckland
Private Bag 92019
Auckland 1142
Country 1551 0
New Zealand
Phone 1551 0
+64 9 923 4259
Fax 1551 0
Nil
Email 1551 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval was not sought for participants' de-identified information to be shared with other researchers. The opinion of the relevant ethics committee in New Zealand would need to be sought before a data sharing agreement could be discussed.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9603Study protocol  [email protected]
9604Informed consent form  [email protected]
9605Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Jull A, Parag V, Walker N, Maddison R, Kerse N, Jo... [More Details]
Plain language summaryNo The exercise programme consisted of three sets pro... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA simple index to predict healing in venous leg ulcers: A secondary analysis from four randomised controlled trials.2023https://dx.doi.org/10.12968/jowc.2023.32.10.657
N.B. These documents automatically identified may not have been verified by the study sponsor.