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Peripheral arterial disease affects around 25% of the UK population aged over 55. Left untreated it can lead to debilitating pain, gangrene, amputation and death. It most commonly affects the lower limbs and in the earlier stages of the disease patients can present with a symptom known as intermittent claudication; pain felt in the legs which stops the patient from walking past a certain distance. Current National Institute for Healthcare and Excellence (NICE) guidelines recommend Supervised Exercise as first line treatment for patients with peripheral arterial disease presenting with intermittent claudication. Supervised exercise employs behaviour changing techniques which enable the patient to modify their lifestyles, improving their claudication symptoms, quality of life and reducing their cardiovascular risk. Despite this treatment being significantly more cost-effective than often employed complex endovascular management, most institutions don't offer such programmes citing lack of resources and compliance from clinicians and patients alike.
The investigators propose a more cost-effective, resource-savvy solution in the form of REmotely SuPervised ExerCise Training (RESPECT). This allows the patient to exercise in the convenience of their own home, at a time of their choosing but still be supervised via fitness tracker technology and an online fitness platform. This randomised controlled trial will attempt to prove its' effectiveness in increasing claudication distance, improving functional ability, decreasing cardiovascular risk and improving quality of life whilst being more cost-effective than the currently recognised national first line treatment. This trial has the potential to revolutionise the management of patients with peripheral arterial disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REmotely SuPervised Exercise Training | Experimental | 12- week home based exercise programme consisting of bi-weekly, hourly sessions at the time and place of the participant's choosing. They will wear a fitness tracker which will automatically upload their exercise data to an online platform which can be monitored by the research team and used to provide additional motivation. |
|
| Supervised Exercise Training | Active Comparator | As per NICE guidance. 12 week, bi-weekly, one hour sessions of supervised exercise training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REmotely SuPervised Exercise Training | Behavioral | As described in the Arms section. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Claudication Distance | Measured using a G-protocol on treadmill testing | At 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Claudication Distance | Measured using a G-protocol on treadmill testing | 6 months and 1 year. |
| Initial Claudication Distance | Measured using a G-protocol on treadmill testing |
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Inclusion Criteria:
Exclusion Criteria:
Critical limb ischaemia
Asymptomatic peripheral arterial disease
Ambulation limited by co-morbid condition other than claudication:
Severe coronary artery disease, angina pectoris, chronic lung disease, neurological disorder, arthritis, amputation
Contraindication to exercise training (AHA guidelines):71 acute MI (within 1 week), unstable angina, uncontrolled cardiac arrhythmias causing symptoms or haemodynamic compromise, active endocarditis, symptomatic severe aortic stenosis, acute pulmonary embolus, acute noncardiac disorder than may be aggravated by exercise such as infection, thyrotoxicosis, acute myocarditis, known physical disability that would preclude safe and adequate testing, known thrombosis of the lower limb, known left main stem coronary stenosis, moderate stenotic valvular heart disease, pulmonary hypertension, hypertrophic cardiomyopathy, atrio-ventricular block.
Psychiatric disorder precluding them from consenting for research and/or exercise training
Arterial reconstruction in the previous 12 months or planned within the next 6 months.
Recent or upcoming major surgery (within 3 months)
Unwilling or unable to attend/perform exercise training
Non-atherosclerotic cause of PAD
Other significant medical problems which impact on the patient's ability to complete a 12-week exercise programme, which could include:
malignancy, chronic renal disease, chronic liver disease or anaemia, active substance abuse, dementia
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Haque | Contact | 01612915848 | adam.haque@manchester.ac.uk |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Supervised Exercise Training | Behavioral | As described in the Arms section. |
|
| 12 weeks, 6 months and one year |
| Health-related Quality of Line | Measured using the Medical Outcomes SF36v2 Questionnaire | 12 weeks, 6 months and one year |
| Cardiovascular Risk Factors | Measured by calculating change in waist circumference and BMI | 12 weeks, 6 months and one year |
| Cost | Measured by the cost of the interventions in each group, including resource and staffing costs. Also includes any unplanned admissions and procedures carried out due to a complication of the disease of interest | 12 weeks, 6 months and one year |
| Habitual physical activity levels | As measured by the physical activity scale for the elderly questionnaire. | 12 weeks, 6 months and one year |
| Adherence | As measured by using the amount of exercise in minutes performed over the 12 weeks, divided by the number of minutes of exercise prescribed x100 | 12 weeks, 6 months and one year |
| D016491 |
| Peripheral Vascular Diseases |