The Effect of Structured Exercise on Chronic Venous Insufficiency

NCT03562546 | Unknown

• 1 other identifier: 369921
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Venous Insufficiency

Keywords

CVI; Calf Muscle Pump Function; Structured Exercise; Varicose Veins

Outcome Measures

Primary Outcomes (3)

• Calf Muscle Pump Function

  Duplex Ultrasound Scanning-to determine the nature and extent of venous reflux

  12 Weeks

• Calf Muscle Strength

  Isokinetic Testing- Biodex

  12 Weeks

• Venous Clinical Severity Score

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

  12 Weeks

Secondary Outcomes (3)

• Ankle Joint Range of Motion

  12 Weeks

• Overall physical strength

  12 Weeks

• Quality of life

  12 Weeks

Study Arms (1)

Structured Resistance Exercise

EXPERIMENTAL

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

Other: Strength From Within

Interventions

Strength From Within OTHER

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.

Structured Resistance Exercise

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with chronic venous insufficiency and a Comprehensive Classification System for Chronic Venous Disorder (CEAP) Score of 2,3,4.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shannon Hernon: lead
• Galway Clinic: collaborator

Study Sites (1)

Galway Clinic

Galway, Ireland

RECRUITING

Related Publications (35)

• 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.

  PMID: 15723761 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 28024458 BACKGROUND

• 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.

  PMID: 24596466 BACKGROUND

• 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.

  PMID: 3395496 BACKGROUND

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

  PMID: 8156326 BACKGROUND

• 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.

  PMID: 17600668 BACKGROUND

• 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.

  PMID: 7494366 BACKGROUND

• 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.

  PMID: 11511615 BACKGROUND

• 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.

  PMID: 1430543 BACKGROUND

• 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.

  PMID: 12422106 BACKGROUND

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

  PMID: 7822904 BACKGROUND

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

  PMID: 3798942 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 19307088 BACKGROUND

• 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.

  PMID: 20546124 BACKGROUND

• 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.

  PMID: 22664280 BACKGROUND

• 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.

  PMID: 22896013 BACKGROUND

• 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.

  PMID: 22345329 BACKGROUND

• 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.

  PMID: 23337196 BACKGROUND

• 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.

  PMID: 21536172 BACKGROUND

• 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.

  PMID: 24974070 BACKGROUND

• 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.

  PMID: 14718821 BACKGROUND

• 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.

  PMID: 19216970 BACKGROUND

• 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.

  PMID: 12170230 BACKGROUND

• 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.

  PMID: 15874941 BACKGROUND

• Eklof B, Rutherford RB, Bergan JJ, Carpentier PH, Gloviczki P, Kistner RL, Meissner MH, Moneta GL, Myers K, Padberg FT, Perrin M, Ruckley CV, Smith PC, Wakefield TW; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg. 2004 Dec;40(6):1248-52. doi: 10.1016/j.jvs.2004.09.027.

  PMID: 15622385 BACKGROUND

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

  PMID: 13696275 BACKGROUND

• 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.

  PMID: 28954574 BACKGROUND

• 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.

  PMID: 8600869 BACKGROUND

• 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.

  PMID: 12787699 BACKGROUND

• 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.

  PMID: 16242978 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Micheál Newell, PhD

  National University of Ireland, Galway, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon M Hernon, PhDStudent

CONTACT

+353867761346; shernon10@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Researcher

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 19, 2018
• Study Start: August 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: February 28, 2019
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

IE (1)