Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000421639
Ethics application status
Approved
Date submitted
12/04/2023
Date registered
28/04/2023
Date last updated
26/05/2024
Date data sharing statement initially provided
28/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Supervised Home-based exercise program for Peripheral Artery Disease Trial
Scientific title
The effect of a Supervised Home-based exercise program on walking distance in Peripheral Artery Disease
Secondary ID [1] 308381 0
None
Universal Trial Number (UTN)
Trial acronym
SHAPE
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease 328179 0
Condition category
Condition code
Cardiovascular 325231 325231 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Design: Prospective, parallel-group, randomized controlled, assessor-blinded clinical trial.

12 week home exercise program involving telehealth supervised exercise sessions delivered by exercise physiologists three times a week for 1hr.

Sessions will involved a 5 min check-in and safety assessment, 5 minute warm up, 3 sets of 10minutes of stepping exercise with 5 minutes rest between sets, 5 mins cool down and 5 mins of post assessment safety checks.

Sessions will occur within groups of 4-6 participants.

Intensity: Stepping until moderate to severe leg pain is induced using the Peripheral Artery Disease (PAD) Intermittent claudication pain scale.

Attendance and work to rest ratio will be recorded for each participant each session.

A qualitative researcher will conduct a semi-structured interview via telephone at the completion of the study. These interviews will be conducted in a subset of approximately 10 participants from each group across multiple centres until data saturation is reached. Participants will be selected randomly.
Intervention code [1] 324831 0
Treatment: Other
Comparator / control treatment
12 week centre based supervised exercise program delivered by a exercise physiologist three times a week for 1hr.

A combination of the treadmill walking, stationary bicycle riding or resistance training formats recommended in the scientific statement from the American Heart Association for the optimal PAD programs will be followed. Sessions will occur within groups of 4-6 participants.

Intensity: To induce moderate to intense ischemic leg pain within 5 to 10 minutes of exercise or moderate intensity determined by rate of perceived exertion (RPE) of 12-14/20.

Attendance and work to rest ratio will be recorded for each participant each session.

A qualitative researcher will conduct a semi-structured interview via telephone at the completion of the study. These interviews will be conducted in a subset of approximately 10 participants across multiple centres until data saturation is reached. Participants will be selected randomly.
Control group
Active

Outcomes
Primary outcome [1] 333087 0
Maximum walking distance during a six-minute walk test
Timepoint [1] 333087 0
Baseline - before participant begins intervention
12 weeks - post completion of intervention
Secondary outcome [1] 415723 0
Health related Quality of life using intermittent claudication questionnaire.
Timepoint [1] 415723 0
Baseline - before participant begins intervention
12 weeks - post completion of intervention
Secondary outcome [2] 415724 0
Risk factor control which includes systolic and diastolic blood pressure assessed using a sphygmomanometer, low density liproprotein-cholesterol (LDL-C) and high density liproprotein cholesterol (HDL-C) assess from blood pathology testing.

These will be assessed as a composite outcome.
Timepoint [2] 415724 0
Baseline - before participant begins intervention
12 weeks - post completion of intervention
Secondary outcome [3] 415725 0
Participant engagement assessed by observation during exercise sessions by the Accredited Exercise Physiologist (AEP) and physical activity using an accelerometer

These will be assessed as a composite outcome.
Timepoint [3] 415725 0
Baseline - before participant begins intervention
12 weeks - post completion of intervention
Secondary outcome [4] 415726 0
Participant satisfaction assessed by custom-designed survey and a semi-structured interview via telephone will be conducted on a subset of participants
Timepoint [4] 415726 0
12 weeks - post completion of intervention
Secondary outcome [5] 415742 0
Exploratory circulating biomarkers of PAD pathology in a subgroup of consenting participants assessed through blood samples.
Timepoint [5] 415742 0
Baseline - before participant begins intervention
12 weeks - post completion of intervention
Secondary outcome [6] 420918 0
Health-related Quality of life assessed using the SF-36
Timepoint [6] 420918 0
Baseline - before participant begins intervention
12 weeks - post completion of intervention
Secondary outcome [7] 420919 0
Health-related Quality of life assessed using the Walking Impairment questionnaire
Timepoint [7] 420919 0
Baseline - before participant begins intervention
12 weeks - post completion of intervention

Eligibility
Key inclusion criteria
1. Symptomatic PAD diagnosed by a specialist based on current guidelines including PAD symptoms, absence of lower limb pulses or resting Ankle-Brachial Pressure Index (ABPI) <0.9 or >1.4, or imaging evidence of lower limb arterial stenosis or occlusion;

2. Able to walk independently, with or without walking aids

3. No currently planned peripheral revascularization

4. Able to complete study induction and safety check successfully.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous major lower limb amputation

2. Patient is deemed unsafe to undertake exercise because of an uncontrolled cardiac, metabolic or musculoskeletal problem or any other condition that may be exacerbated by exercising

3. Unable to engage with telehealth (e.g. uncorrected blindness, deafness or cognitive impairment)

4. Terminal illness with prognosis of less than 6 months

5. Involvement in another clinical trial

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)
Randomization will be conducted using a secure, independent web-based minimization randomization system (Sealed Envelope)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sequence for study arm allocation will be generated prior to commencement. Randomization will be in a 1:1 ratio between SHAPE and the centre-based program. Participant randomization will be done after the baseline visit when all relevant data has been received. Randomization will be stratified by study centre, gender, age and 6MWT distance (<320, 320-420, >420m).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All participants will be included in the primary analysis according to their randomly allocated treatment (intention-to-treat). Linear mixed effect modelling allows for inclusion of participants with missing data and will be used. The hypothesis testing of continuous primary and other outcomes will be performed using generalized mixed effect models using the interaction of time and group as the test statistic. The exact model will depend on the type of outcome measure. A p-value <0.05 will be considered significant. A cost utility analysis will be performed to compare the cost-effectiveness of the two exercise programs. This evaluation will adopt a health system perspective, including estimates of all health care costs, such as drugs, doctors’ visits and in-patient charges and costed using standard Australian list prices. Health utility scores will be generated for each participant by converting responses to the SF-36 into a single SF-6D score using validated algorithms and applying Australian utility weights which we previously developed. These analyses will generate costs per Quality-Adjusted Life Year (QALY) gained and include sensitivity analyses.
Qualitative data from the interviews and surveys will analysed using content analysis to identify and quantify key concepts in relation to the acceptability of type of exercise program. Transcribed interviews will undergo thematic analysis independently by two researchers, involving deductive coding. Themes will be derived from coded transcripts, with discrepancies in themes identified and discussed by the research team to reach consensus. NVivo qualitative data analysis software will be used to assist in the analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
8/09/2023
Date of last participant enrolment
Anticipated
1/03/2026
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
130
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 23532 0
Townsville University Hospital - Douglas
Recruitment hospital [2] 23533 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 23534 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 23535 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 38950 0
4814 - Douglas
Recruitment postcode(s) [2] 38951 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [3] 38953 0
4575 - Birtinya
Recruitment postcode(s) [4] 38954 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 38956 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 312632 0
Government body
Name [1] 312632 0
National Health and Medical Research Council
Country [1] 312632 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
James Cook Drive
Douglas, Townsville
Queensland 4811
Country
Australia
Secondary sponsor category [1] 314243 0
None
Name [1] 314243 0
Address [1] 314243 0
Country [1] 314243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311948 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 311948 0
IMB 101, Level 2, Townsville University Hospital
100 Angus Smith Drive, Douglas, QLD, 4814
Ethics committee country [1] 311948 0
Australia
Date submitted for ethics approval [1] 311948 0
13/10/2022
Approval date [1] 311948 0
16/11/2022
Ethics approval number [1] 311948 0
HREC/QTHS/89483

Summary
Brief summary
Peripheral artery disease (PAD) involves blockages in the leg arteries, leading to exertional lower-limb pain and reduced physical capacity and quality of life. Supervised exercise therapy is an effective treatment for impaired walking due to peripheral artery disease. However, availability and uptake of supervised exercise therapy is limited, perhaps due to the requirement to attend a central facility. The SHAPE trial is a multi-centre, prospective, parallel-group, randomized controlled and assessor-blinded trial. 130 eligible participants with peripheral artery disease will be recruited and consented to the study. In this randomised controlled trial (RCT) the effectiveness and acceptability of SHAPE is compared to current standard of care (centre-based supervised exercise). Participants will be randomly allocated to one of these programs.
SHAPE is evidence-based and was designed in partnership with patients, GPs, vascular surgeons and AEPs. This exercise program is done entirely within the participants’ home, supervised by AEPs using telehealth and uses behavioural monitoring via a worn accelerometer.
The tertiary facility centre-based supervised exercise program is a exercise program run at a tertiary facility in line with current guidelines.

Both programs provide supervised exercise three times per week for 12 weeks.
The primary outcome is to test the non-inferiority of SHAPE compared to the centre-based exercise program through a difference of less than 20m during a six minute walk test.
Secondary outcomes include health-related quality of life (HRQOL), cardiovascular risk factors, engagement with the program, and participant satisfaction assessed by a survey and, in a sub-set of participants, through interviews.
Trial website
https://www.jcu.edu.au/qrcpvd/get-involved
Trial related presentations / publications
Public notes
Details of the SHAPE study will be added to the website once all approvals for the study have been received.

Contacts
Principal investigator
Name 48702 0
Prof Jonathan Golledge
Address 48702 0
JCU Research Block, Ground Floor
Townsville University Hospital
100 Angus Smith Drive, Douglas, QLD, 4814
Country 48702 0
Australia
Phone 48702 0
+61 7 4781 4838
Fax 48702 0
Email 48702 0
[email protected]
Contact person for public queries
Name 48703 0
Prof Jonathan Golledge
Address 48703 0
JCU Research Block, Ground Floor
Townsville University Hospital
100 Angus Smith Drive, Douglas, QLD, 4814
Country 48703 0
Australia
Phone 48703 0
+61 7 4781 4838
Fax 48703 0
Email 48703 0
[email protected]
Contact person for scientific queries
Name 48704 0
Prof Jonathan Golledge
Address 48704 0
JCU Research Block, Ground Floor
Townsville University Hospital
100 Angus Smith Drive, Douglas, QLD, 4814
Country 48704 0
Australia
Phone 48704 0
+61 7 4781 4838
Fax 48704 0
Email 48704 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
Data will not be shared as this was not originally written in the study protocol. Our protocol does not have HREC approval for data sharing and this was not included in the PICF


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.