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 TEAL trial is a multi-centre, prospective, parallel-group, randomized controlled and assessor-blinded trial. 236 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 TEAL is compared to usual care. Participants will be randomly allocated to one of these groups for 6 months: TEAL, a supervised home base exercise program delievered using telehealth. AEPs will supervised patients and use worn accelerometer to monitor exercise behaviour. The usual group will receive monthly telehealth contact which are unrelated to exercise The primary outcome is maximium distance walked 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.
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 in
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
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. 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.
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
Outcome results
None listed