None listed
Conditions
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.
Interventions
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
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.
Sponsors
James Cook University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed