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Trial registered on ANZCTR


Registration number
ACTRN12622001566729
Ethics application status
Approved
Date submitted
7/12/2022
Date registered
19/12/2022
Date last updated
30/11/2023
Date data sharing statement initially provided
19/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a novel exercise and behavioural support tele-health program for participants with peripheral artery disease related walking impairment.
Scientific title
Effect of a novel exercise and behavioural support tele-health program for participants with peripheral artery disease related walking impairment.
Secondary ID [1] 308385 0
None
Universal Trial Number (UTN)
Trial acronym
TEAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease 328183 0
Condition category
Condition code
Cardiovascular 325236 325236 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.

6 month home exercise program involving telehealth supervised exercise sessions delivered by Accredited Exercise Physiologists (AEP) three times a week for 1hr in group sessions of between 4 to 6 participants. The 1hr session will consist of 5min check-in and safety assessment, 5 min of warm-up, 40mins of stepping exercise, 5 min of cool down and 5 min of post-exercise assessment.

The exercise intensity will be at near maximum pain intensity (3-4 out of 5 on pain scale) reported by participants. The AEP will demonstrate exercise variations and sequences to involve more (progression) or less effort (regression) depending on tolerance. For example the exercise component may include knee lifts and to increase the intensity (progression) these are done faster and higher, if the intensity needs to decrease (regression) then these movements will be done slower. The intensity of the exercise will be determined by participant reporting their tolerance. AEP will keep a track of participant attendance to monitor engagement and adherence to the intervention

Month 0-2 all exercise sessions will be delivered by a exercise physiologist.
Month 3-4 two exercise sessions will be delivered by a exercise physiologist and 1 will be self-directed by the participant based on the same format at the supervised sessions.
Month 5-6 one exercise session will be delivered by a exercise physiologist and 2 will be self-directed
Intervention code [1] 324837 0
Treatment: Other
Comparator / control treatment
Monthly telehealth contacts which last for approximately 30-60mins will be provided for 6 months. During these sessions, participants will be asked open ended questions about their Peripheral Artery Disease (PAD) and wellbeing. These will be conducted by a member of the study team e.g. study coordinator
Control group
Active

Outcomes
Primary outcome [1] 333089 0
Maximum walking distance during a six minute walk test
Timepoint [1] 333089 0
Baseline and 6 months post-randomisation
Secondary outcome [1] 415740 0
Generic quality of life assessed using generic SF-36
Timepoint [1] 415740 0
Baseline and 6 months post-randomisation
Secondary outcome [2] 415741 0
Physical activity will be assessed using a accelerometer worn for 7 days. This will include step count and exercise intensity in METs
Timepoint [2] 415741 0
Baseline, 6 weeks and 6months post-randomisation
Secondary outcome [3] 415743 0
Those randomised to TEAL will have participant engagement assessed using a composite measure including time spent exercising as observed during exercise sessions by the AEP and physical activity using an accelerometer
Timepoint [3] 415743 0
6 months post-randomisation
Secondary outcome [4] 415744 0
Those randomised to TEAL will have participant satisfaction assessed by custom-designed survey.

A subset of 30-50 participants will undergo a semi-structured interview via telephone. The subset of participants will be selected based on which participants consents to taking part in the interview.
Timepoint [4] 415744 0
6 months post-randomisation
Secondary outcome [5] 415746 0
Major Cardiovascular Event (MACE) is a composite measure defined by myocardial infarction, stroke or cardiovascular death). These will be assessed using participant's medical records
Timepoint [5] 415746 0
6 months post-randomisation
Secondary outcome [6] 416740 0
Condition specific quality of life assessed through intermittent claudication questionnaire
Timepoint [6] 416740 0
Baseline and 6 month post-randomisation
Secondary outcome [7] 416751 0
Major Adverse Limb Event (MALE) is a composite measure defined by lower limb revascularisation (open or endovascular procedure) or major amputation (above or below knee). This will be assessed using information collected through phone call at 6 months and from patient's medical records.
Timepoint [7] 416751 0
6 months post-randomisation

Eligibility
Key inclusion criteria
1. PAD diagnosed by a specialist based on current guidelines including PAD symptoms, absence of lower limb pulses or resting 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. 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. Severe PAD, e.g. rest pain or gangrene, requiring urgent peripheral revascularisation;
2. Previous major lower limb amputation
3. 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
4. A condition that requires high level medical care such as, but not limited to, renal dialysis or regular cancer treatment that impacts ability to complete regular exercise sessions
5. Unable to engage with Tele-artery (e.g. uncorrected blindness, deafness or mental impairment)
6. Terminal illness with prognosis of less than six months or involvement in another 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)
Allocation will be concealed through use of an off-site randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted using a secure, independent web-based minimization randomization system (Sealed Envelope). A random sequence for study arm allocation will be generated prior to commencement. Randomization will be in a 1:1 ratio between TEAL and the usual care group. 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 at entry(<300, 300-420, >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). 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. Qualitative data from the interviews and surveys will analysed using content analysis to identify and quantify key concepts in relation to the acceptability of study intervention. 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. The incidence of limb events will be compared using time to event and Cox proportional hazard analysis. If necessary, and assumptions are met, multiple imputation will be used to impute missing values. If a significant
positive effect of Tele-artery on HRQOL is observed, a cost utility analysis will be performed. 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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/01/2023
Actual
4/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
236
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23539 0
Townsville University Hospital - Douglas
Recruitment hospital [2] 23540 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 23541 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 38958 0
4814 - Douglas
Recruitment postcode(s) [2] 38959 0
4029 - Herston
Recruitment postcode(s) [3] 38960 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 296238 0
Government body
Name [1] 296238 0
National Health and Medical Research Council
Country [1] 296238 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
James Cook Drive
Douglas, Townsville
Queensland 4811
Country
Australia
Secondary sponsor category [1] 314246 0
None
Name [1] 314246 0
Address [1] 314246 0
Country [1] 314246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297478 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 297478 0
Ethics committee country [1] 297478 0
Australia
Date submitted for ethics approval [1] 297478 0
22/07/2022
Approval date [1] 297478 0
07/10/2022
Ethics approval number [1] 297478 0
HREC/2022/QTHS/87456

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74174 0
Prof Jonathan Golledge
Address 74174 0
JCU Research Block, Ground Floor
Townsville University Hospital
100 Angus Smith Drive, Douglas, QLD, 4814
Country 74174 0
Australia
Phone 74174 0
+61 7 4781 4838
Fax 74174 0
Email 74174 0
jonathan.golledge@jcu.edu.au
Contact person for public queries
Name 74175 0
Jonathan Golledge
Address 74175 0
JCU Research Block, Ground Floor
Townsville University Hospital
100 Angus Smith Drive, Douglas, QLD, 4814
Country 74175 0
Australia
Phone 74175 0
+61 7 4781 4838
Fax 74175 0
Email 74175 0
jonathan.golledge@jcu.edu.au
Contact person for scientific queries
Name 74176 0
Jonathan Golledge
Address 74176 0
JCU Research Block, Ground Floor
Townsville University Hospital
100 Angus Smith Drive, Douglas, QLD, 4814
Country 74176 0
Australia
Phone 74176 0
+61 7 4781 4838
Fax 74176 0
Email 74176 0
jonathan.golledge@jcu.edu.au

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.