The RESPECT-PAD Trial

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Randomised Controlled Trial of REmotely SuPervised Exercise Training for Patients With Peripheral Arterial Disease: The RESPECT-PAD Trial

Conditions
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Peripheral Arterial Disease, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: REmotely SuPervised Exercise Training
* Behavioral: Supervised Exercise Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients willing and able to undertake supervised or home-based exercise training aged between 40 and 85 Positive Edinburgh questionnaire for intermittent claudication (APPENDIX H) Proven peripheral arterial disease on diagnostic imaging Ankle Brachial Pressure Index (ABPI) <0.9 Fontaine Classification (APPENDIX I) of PAD Stage II Conservative management plan agreed for by Consultant Vascular Surgeon. 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REmotely SuPervised Exercise Training<br>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. | Behavioral: REmotely SuPervised Exercise Training<br>* As described in the Arms section.<br>|
| Active Comparator: Supervised Exercise Training<br>As per NICE guidance. 12 week, bi-weekly, one hour sessions of supervised exercise training. | Behavioral: Supervised Exercise Training<br>* As described in the Arms section.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Claudication Distance | Measured using a G-protocol on treadmill testing | At 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |