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Setting Up a Vascular Collaboration Research Project

Setting Up a Vascular Collaboration Research Project. Sohail Choksy Consultant Surgeon, CHUFT Prof Ralph Beneke Essex University. Atherosclerosis affects all arterial beds. Cerebrovascular disease Ischaemic stroke Transient Ischaemic Attack (TIA). Cardiovascular disease

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Setting Up a Vascular Collaboration Research Project

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  1. Setting Up a Vascular Collaboration Research Project Sohail Choksy Consultant Surgeon, CHUFT Prof Ralph Beneke Essex University

  2. Atherosclerosis affects all arterial beds • Cerebrovascular disease • Ischaemic stroke • Transient Ischaemic Attack (TIA) • Cardiovascular disease • Myocardial Infarction (MI) • Angina (stable/unstable) • Peripheral arterial disease (PAD) • Intermittent claudication • Pain on walking • Severe limb ischaemia • Rest pain • Gangrene, necrosis

  3. Prevalance and risk factors • 5% 55-74 y Claudication, further 8% asymptomatic • Risk factors • Increasing age (>50 yrs old) • Diabetes 2-3X • Smoking 2X • Hypertension 2.5-4X • Hyperlipidaemia 2X • Ethnicity, gender, homocysteinaemia, previous MI Belch et al Arch Int Med. 2003;163: 884-892

  4. Peripheral Arterial Disease (PAD) • Symptomatology • Asymptomatic • Intermittent claudication • Critical limb ischaemia

  5. SymptomatologyIntermittent claudication • “Claudere” to limp • Pain is muscular and cramp-like • Absent at rest, brought on by exercise • Pain relieved within a few minutes of stopping exercise • Pain occurs in muscle group downstream to the diseased artery • Affects walking speed normal 3mph, claudicant 1-2mph

  6. Claudication blood supply

  7. ABPI Diagnosis of PAD Clinical history Physical examination Ankle Brachial Pressure Index (ABPI) Exercise test Duplex ultrasonography Angiography

  8. Natural History of claudication

  9. Symptomatology:Critical limb ischaemia Definition • Inadequate arterial blood flow for the metabolic needs of the tissues at rest Symptoms • Rest pain • Ulcers/gangrene • Doppler pressures • 50mm Hg at ankle • 30 mm Hg at toes • Quality of life similar to terminal cancer

  10. Reduce cardiovascular risk Treating Peripheral arterial disease Reduce symptoms and improve quality of life Exercise Therapy Pharmacological treatment Radiological or surgical treatment • Lifestyle modification • Smoking cessation • Exercise • Diet, weight reduction • Secondary prevention • Antiplatelet • Statins (lipid control) • BP control, diabetic control

  11. Exercise Therapy • Little evidence that exercise advice is effective • Supervised exercise therapy is associated with • Improvement in max walking time (5.12 minutes (95% confidence interval (CI) 4.51 to 5.72;) • pain-free walking distance 82.19 metres (95% CI 71.73 to 92.65) • Max walking distance of 113.20 metres (95% CI 94.96 to 131.43) • No improvement in ABPI Cochrane Database Syst Rev. 2008 Oct 8;(4):CD000990. Exercise for intermittent claudication. Watson L, Ellis B, Leng GC.

  12. Mechanism of improvement in Claudication • Mechanism of improvement of walking distance in claudication unknown • Local or systemic effect? • Possible explanations: • Improved blood flow • Altered gait • Improved extraction of oxygen by muscles i.e. Metabolic • Pain tolerance • Improved cardiovascular fitness

  13. Research Questions • What is/are the dominant mechanism(s) by which exercise causes an improvement in walking performance in claudicants? • How can we tailor exercise to optimise improvement?

  14. What we need

  15. Setting up a research collaboration • Project in drawing board stage in “evolution” • Collaborators: • CHUNT: Sohail Choksy, Adam Howard, Chris Backhouse and Emma Raynar • Essex University: R Beneke, C Cooper, A Wittekind, MJD Taylor, RM Leithäuser, T Cudmore • Multidisciplinary project combining expertises in Sports and Exercise Medicine, Vascular Surgery, Patho- and Exercise Physiology, Biomechanics, Biomedical Sciences and Sport Science Support

  16. Subjects • Patients with stable intermittent claudication whose symptoms do not warrant surgical or radiological revascularisation • Diagnosis based on history and ABPI<0.9 • Exclude patients on drugs for claudication e.g. Cilostazol • No other cause limiting exertion e.g. COPD and CHD • Patients recruited into Colchester Vascular Rehabilitation Programme

  17. Vascular Rehabilitation programme • Run by Vascular Nurse Specialist (Emma Rayner) and 2 physiotherapists • Two one hour sessions per week • 8 week course with assessments at beginning and end of course • Brief warm up, general stretch and shake! • Then rotate around 10 stations which are aimed at improving general fitness and working calf muscle. • All stations timed for 3 minutes then on to next one.

  18. Exercise Regimen • Stations are • 1 Treadmill (speed and gradient adjusted according to pt, aim to bring on claudication to level 3) • 2 Trampette ( heel raises on trampette) • 3 Toe walking • 4 Static bike • 5 Round wobble board (move board in circle on floor) • 6 Theraband ( around foot and move foot up and down to exercise calf) • 7 Step ups • 8 Square wobble board ( against bars, they have to wobble it back and forwards) • 9 Arm raises ( holding large ball) • 10 Sitting and standing from chair.

  19. Study Design: Pilot Study • Initial pilot study to gather preliminary data to apply for a grant application • Simple observational study using current established exercise regimen • Aim to answer: • How is the extent of lower limb ischemia associated with claudication pain and temporal and spatial gait measures during self paced ambulation? • How do subsequent exercise interventions affect exercise intensity and exercise induced effort and pain sensations?

  20. Study Design: Pilot Study • Assess maximum walking distance on site at baseline and completion of programme • Flat surface, not on treadmill • Steps recorded on 2 cameras for gait analysis • Muscle ischaemia: Near infra red spectroscopy (NIRS) to assess oxygen saturation of calf musculature in affected leg • Effort monitoring and pain scale • Heart rate and spirometry

  21. NIRS Gardner et al J Vasc Surg. 2008 Sep;48(3):644-9

  22. Study Design During exercise training monitoring of: • What was really done • Heart rate • NIRS of affected leg • pain scale monitoring • Overall effort monitoring

  23. The Future • Larger study comparing the effect of exercise in claudicants Vs age matched controls on muscle ischaemia, gait analysis, pain perception and exercise intensity • Develop novel exercises which optimise performance in claudicants • Setting up a research infrastructure will create further potential avenues of research • Monitoring the effect of pharmacological agents on exercise performance e.g. Cilostazol and Pentoxifylline • Monitoring effect of novel methods to improve muscle perfusion e.g. Calf compression and electrical muscle stimulation

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