The Effect of Structured Exercise on Chronic Venous Insufficiency (CVI)

Individuals with Chronic Venous Insufficiency (CVI) face a number of complications, such as, muscular dysfunction, limited ankle range of motion(ROM) and diminished calf muscle pump function. Exercise therapy has been shown to improve calf muscle pump function and symptoms and may provide additional therapeutic benefits. It has been reported that structured exercise has the ability to improve ankle joint range of motion, calf muscle strength and calf muscle pump function. Participants will receive the 12-week structured resistance exercise programme, 'Strength from Within', a warm up and cool down, walking programme and range of motion exercises. Participants will complete the Short Form quality of life (SF-36) Health Survey and the venous clinical severity score questionnaire. Baseline testing will be conducted. The following measures will be employed in the study through a baseline testing and repeated at the end of the study period (week 12): Functional ambulatory measurements, physical activity measurements (muscle endurance), isokinetic testing (strength), duplex ultrasound scanning. A combination of upper and lower body structured exercise as well as, ankle join range of motion and a walking regimen has the potential to have a significant impact on an individual's calf muscle pump function and avoid these potentially harmful side effects of lower body exercise programmes

There will be a total of sixty participants recruited for the study, with an anticipation of 40 to complete the study. Participants will complete the Physical Activity Readiness Questionnaire (PAR-Q) to ensure that they are able to participate in the structured exercise programme. If the participants' answers "yes" to any question on the Physical Activity Readiness Questionnaire (PAR-Q), he/she is ineligible to participate. Participants will also read a participant information leaflet and sign an informed consent before participating in the study. Baseline demographic will be collected at the start of the study. Participants will complete the SF-36 Health Survey at session one and session 2 (week 12). Baseline testing will be conducted. The following measures will be employed in the study through a baseline testing and repeated at the end of the study period (week 12): Functional ambulatory measurements, physical activity measurements, isokinetic testing, duplex ultrasound screening. Upon completing baseline testing participants will have the warm-up, cool-down, stretches, all exercise demonstrated and explained to them. Participants will go through each exercise with the principal investigator to ensure understanding. The principal investigator will then describe each section of the "Strength From Within" Booklet. At the end of the first session the participants will be administered their at home structured exercise booklet, recording booklet, resistance band, warm-up and cool-down information sheet and their ankle range of motion information sheet. The baseline meeting and the week 12 meeting will take roughly 90 minutes to complete all baseline measurements, questionnaires, isokinetic testing and demonstrations. Isokinetic testing will take a total of 32 minutes with resting periods included in the time, baseline measurements including the muscle strength and functional ambulatory measurements will take a duration of 10.5 minutes, demonstration of the home structured exercise programme will take up to 20 minutes, both questionnaires will take 5-minutes total and time left for any other questions or concerns. Extra time will be given at any point during both meetings if needed by the participant.

12 week at home structured resistance exercise programme ('Strength From Within') using resistance bands. Under the supervision of an experienced exercise specialist.

A 12 week at home structured resistance exercise programme using resistance bands. Participants will also receive a walking programme, a warm up and cool down, and ankle range of motion exercises.

Questionnaire assessing severity of the patients' chronic venous insufficiency and to monitor any progression made

Inclusion Criteria: Adult patients with chronic venous insufficiency and a Comprehensive Classification System for Chronic Venous Disorder (CEAP) Score of 2,3,4. Exclusion Criteria: Younger than 18 years Painful Ulceration Severe Cardiac Condition Cardiorespiratory Disease Failure of Physical Activity Readiness form American College of Sports Medicine (ACSM) Risk Classification: Class C or above CEAP classification of 5 or 6 Severe mobility impairment Severe imbalance Women who are pregnant Women who are breastfeeding Those who lack capacity to consent Those for whom English is not the first language and have difficulty understanding written and/or spoken English Diagnosis of diabetes Diagnosis of peripheral arterial disease Diagnosis of peripheral neuropathy

Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.

O'Donovan K, Bajd T, Grace P, O'Keeffe D, Lyons G. Preliminary Evaluation of Recommended Airline Exercises for Optimal Calf Muscle Pump Activity. EJVES Extra. 2006;12(1):1-5. doi:10.1016/j.ejvsextra.2006.04.001

Dua A, Heller JA. Advanced Chronic Venous Insufficiency. Vasc Endovascular Surg. 2017 Jan;51(1):12-16. doi: 10.1177/1538574416682175. Epub 2016 Dec 26.

White-Chu EF, Conner-Kerr TA. Overview of guidelines for the prevention and treatment of venous leg ulcers: a US perspective. J Multidiscip Healthc. 2014 Feb 11;7:111-7. doi: 10.2147/JMDH.S38616. eCollection 2014.

Brand FN, Dannenberg AL, Abbott RD, Kannel WB. The epidemiology of varicose veins: the Framingham Study. Am J Prev Med. 1988 Mar-Apr;4(2):96-101.

Callam MJ. Epidemiology of varicose veins. Br J Surg. 1994 Feb;81(2):167-73. doi: 10.1002/bjs.1800810204.

Chiesa R, Marone EM, Limoni C, Volonte M, Petrini O. Chronic venous disorders: correlation between visible signs, symptoms, and presence of functional disease. J Vasc Surg. 2007 Aug;46(2):322-30. doi: 10.1016/j.jvs.2007.04.030. Epub 2007 Jun 27.

Scott TE, LaMorte WW, Gorin DR, Menzoian JO. Risk factors for chronic venous insufficiency: a dual case-control study. J Vasc Surg. 1995 Nov;22(5):622-8. doi: 10.1016/s0741-5214(95)70050-1.

Fowkes FG, Lee AJ, Evans CJ, Allan PL, Bradbury AW, Ruckley CV. Lifestyle risk factors for lower limb venous reflux in the general population: Edinburgh Vein Study. Int J Epidemiol. 2001 Aug;30(4):846-52. doi: 10.1093/ije/30.4.846.

Sadick NS. Predisposing factors of varicose and telangiectatic leg veins. J Dermatol Surg Oncol. 1992 Oct;18(10):883-6. doi: 10.1111/j.1524-4725.1992.tb02921.x.

Iannuzzi A, Panico S, Ciardullo AV, Bellati C, Cioffi V, Iannuzzo G, Celentano E, Berrino F, Rubba P. Varicose veins of the lower limbs and venous capacitance in postmenopausal women: relationship with obesity. J Vasc Surg. 2002 Nov;36(5):965-8. doi: 10.1067/mva.2002.128315.

Evans CJ, Fowkes FG, Hajivassiliou CA, Harper DR, Ruckley CV. Epidemiology of varicose veins. A review. Int Angiol. 1994 Sep;13(3):263-70.

Browse NL. The etiology of venous ulceration. World J Surg. 1986 Dec;10(6):938-43. doi: 10.1007/BF01658644. No abstract available.

Browse N, Burnand K. CAUSE OF VENOUS ULCERATION. The Lancet. 1982;320(8304):932. doi:10.1016/s0140-6736(82)90901-1.

Darvall KA, Sam RC, Adam DJ, Silverman SH, Fegan CD, Bradbury AW. Higher prevalence of thrombophilia in patients with varicose veins and venous ulcers than controls. J Vasc Surg. 2009 May;49(5):1235-41. doi: 10.1016/j.jvs.2008.12.017.

Allison MA, Cushman M, Callas PW, Denenberg JO, Jensky NE, Criqui MH. Adipokines are associated with lower extremity venous disease: the San Diego population study. J Thromb Haemost. 2010 Sep;8(9):1912-8. doi: 10.1111/j.1538-7836.2010.03941.x.

Serra R, Buffone G, de Franciscis A, Mastrangelo D, Molinari V, Montemurro R, de Franciscis S. A genetic study of chronic venous insufficiency. Ann Vasc Surg. 2012 Jul;26(5):636-42. doi: 10.1016/j.avsg.2011.11.036.

Anwar MA, Georgiadis KA, Shalhoub J, Lim CS, Gohel MS, Davies AH. A review of familial, genetic, and congenital aspects of primary varicose vein disease. Circ Cardiovasc Genet. 2012 Aug 1;5(4):460-6. doi: 10.1161/CIRCGENETICS.112.963439. No abstract available.

Vlajinac HD, Radak DJ, Marinkovic JM, Maksimovic MZ. Risk factors for chronic venous disease. Phlebology. 2012 Dec;27(8):416-22. doi: 10.1258/phleb.2011.011091. Epub 2012 Feb 16.

Vlajinac HD, Marinkovic JM, Maksimovic MZ, Matic PA, Radak DJ. Body mass index and primary chronic venous disease--a cross-sectional study. Eur J Vasc Endovasc Surg. 2013 Mar;45(3):293-8. doi: 10.1016/j.ejvs.2012.12.011. Epub 2013 Jan 20.

Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.

O'Donnell TF Jr, Passman MA, Marston WA, Ennis WJ, Dalsing M, Kistner RL, Lurie F, Henke PK, Gloviczki ML, Eklof BG, Stoughton J, Raju S, Shortell CK, Raffetto JD, Partsch H, Pounds LC, Cummings ME, Gillespie DL, McLafferty RB, Murad MH, Wakefield TW, Gloviczki P; Society for Vascular Surgery; American Venous Forum. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (R) and the American Venous Forum. J Vasc Surg. 2014 Aug;60(2 Suppl):3S-59S. doi: 10.1016/j.jvs.2014.04.049. Epub 2014 Jun 25. No abstract available.

Padberg FT Jr, Johnston MV, Sisto SA. Structured exercise improves calf muscle pump function in chronic venous insufficiency: a randomized trial. J Vasc Surg. 2004 Jan;39(1):79-87. doi: 10.1016/j.jvs.2003.09.036.

Eklof B, Perrin M, Delis KT, Rutherford RB, Gloviczki P; American Venous Forum; European Venous Forum; International Union of Phlebology; American College of Phlebology; International Union of Angiology. Updated terminology of chronic venous disorders: the VEIN-TERM transatlantic interdisciplinary consensus document. J Vasc Surg. 2009 Feb;49(2):498-501. doi: 10.1016/j.jvs.2008.09.014.

Caggiati A, Bergan JJ, Gloviczki P, Jantet G, Wendell-Smith CP, Partsch H; International Interdisciplinary Consensus Committee on Venous Anatomical Terminology. Nomenclature of the veins of the lower limbs: an international interdisciplinary consensus statement. J Vasc Surg. 2002 Aug;36(2):416-22. doi: 10.1067/mva.2002.125847.

Caggiati A, Bergan JJ, Gloviczki P, Eklof B, Allegra C, Partsch H; International Interdisciplinary Consensus Committee on Venous Anatomical Terminology. Nomenclature of the veins of the lower limb: extensions, refinements, and clinical application. J Vasc Surg. 2005 Apr;41(4):719-24. doi: 10.1016/j.jvs.2005.01.018.

Eklöf, Rutherford, Bergan et al. Revision of the CEAP classification for chronic venous disorders: a consensus statement. Vasa. 2005;34(3):157-161. doi:10.1024/0301-1526.34.3.157.

CRANLEY JJ, KRAUSE RJ, STRASSER ES. Chronic venous insufficiency of the lower extremity. Surgery. 1961 Jan;49:48-58. No abstract available.

Ercan S, Cetin C, Yavuz T, Demir HM, Atalay YB. Effects of isokinetic calf muscle exercise program on muscle strength and venous function in patients with chronic venous insufficiency. Phlebology. 2018 May;33(4):261-266. doi: 10.1177/0268355517695401. Epub 2017 Mar 7.

Andersen H. Reliability of isokinetic measurements of ankle dorsal and plantar flexors in normal subjects and in patients with peripheral neuropathy. Arch Phys Med Rehabil. 1996 Mar;77(3):265-8. doi: 10.1016/s0003-9993(96)90109-4.

Dix FP, Brooke R, McCollum CN. Venous disease is associated with an impaired range of ankle movement. Eur J Vasc Endovasc Surg. 2003 Jun;25(6):556-61. doi: 10.1053/ejvs.2002.1885.

Clarke Moloney M, Lyons GM, Breen P, Burke PE, Grace PA. Haemodynamic study examining the response of venous blood flow to electrical stimulation of the gastrocnemius muscle in patients with chronic venous disease. Eur J Vasc Endovasc Surg. 2006 Mar;31(3):300-5. doi: 10.1016/j.ejvs.2005.08.003. Epub 2005 Oct 20.

Boyle M, Galway B, McLaughlin T et al. Evidence-Based Clinical Protocols: 3) Anterior Cruciate Ligament Injury & Reconstruction. New York; 2006:3-3. Available at: http://www.biodex.com/sites/default/files/900521anterior.pdf.

Boyle M, Jacoby S, McLaughlin T et al. Evidence-Based Clinical Protocols 5) Lateral Ankle Sprains. New York; 2006:5-9. Available at: http://www.biodex.com/sites/default/files/900521lateral.pdf.

Get walking with this 12-week walking schedule - Mayo Clinic. Mayo Clinic. 2017. Available at: http://www.mayoclinic.org/healthy-lifestyle/fitness/in-depth/walking/art-20050972.