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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 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]

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

Condition category

Condition code

Cardiovascular

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]

Treatment: Other

Comparator / control treatment

Control: Usual care - normal exercise advice given to people with venous ulcers.

Control group

Active

Outcomes

Primary outcome [1]

Calf muscle function at 12 weeks measured by changes from baseline in ejection fraction and residual volume fraction determined by air plethysmography

Timepoint [1]

Calf muscle function measured at baseline and 12 weeks.

Secondary outcome [1]

Acceptability and tolerability of exercise intervention as measured by compliance with exercise prescription.

Timepoint [1]

at 3, 6, 9 and 12 weeks

Secondary outcome [2]

Withdrawals and adverse events

Timepoint [2]

at 12 weeks

Secondary outcome [3]

Proportion healed

Timepoint [3]

at 12 weeks

Secondary outcome [4]

Time to healing

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

Auckland

Country [1]

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]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Regional Ethics Committee Y

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

20/11/2006

Ethics approval number [1]

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

Prof Andrew Jull

Address

School of Nursing
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+64 9 923 4259

Fax

[email protected]

Contact person for public queries

Name

Andrew Jull

Address

School of Nursing
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+64 9 923 4259

Fax

Nil

[email protected]

Contact person for scientific queries

Name

Andrew Jull

Address

School of Nursing
University of Auckland
Private Bag 92019
Auckland 1142

Country

New Zealand

Phone

+64 9 923 4259

Fax

Nil

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email
9603	Study protocol	[email protected]
9604	Informed consent form	[email protected]
9605	Ethical approval	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A simple index to predict healing in venous leg ulcers: A secondary analysis from four randomised controlled trials.	2023	https://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.

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