Effects of Different Protocols of Physical Training on Levels of Muscle Strength and Functional Capacity

Peripheral Arterial Disease Clinical Trial

Official title:

Effects of Different Protocols of Physical Training on Levels of Muscle Strength and Functional Capacity on Patients With Peripheral Artery Disease: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03092336
• Other study ID #: 11-0566
• Status: Recruiting
• Phase: N/A
• First received: March 21, 2017
• Last updated: March 21, 2017
• Start date: May 2011
• Est. completion date: March 2018

Study information

• Verified date: March 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Márcio Garcia, MD
• Phone: 05551597634
• Email: mgmarciogarcia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: the peripheral obstructive arterial disease is an condition that affects around 15% of the world population interfering in muscle strength, life quality and functional capacity of patients.

Description:

Study aim: to assess three methods of physical training (strength training, aerobic training and electrical stimulation training) in muscle strength, functional capacity and life quality of patients with peripheral obstructive arterial disease

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of PAD and IC.

• Age from 40 to 80 years.

• Stage I and II of Fontaine.

• Symptoms of Intermittent Claudication for at least 3 months with resting brachial index = 0.90 in 1 or 2 legs

Exclusion Criteria:

• Critical ischemia in one of the lower limbs.

• Moderate or severe ulcers in one of the lower limbs. Orthopedic problems that prevent exercise or evaluation.

• Participation in other studies with rehabilitation.

• Decreased arterial hypertension.

• Decompensated Diabetes

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Electrical Stimulation
electrical stimulation training
• Strength training
strength training group

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (53)

Adams J, Ogola G, Stafford P, Koutras P, Hartman J. High-intensity interval training for intermittent claudication in a vascular rehabilitation program. J Vasc Nurs. 2006 Jun;24(2):46-9. — View Citation

Ambrosetti M, Salerno M, Boni S, Daniele G, Tramarin R, Pedretti RF. Economic evaluation of a short-course intensive rehabilitation program in patients with intermittent claudication. Int Angiol. 2004 Jun;23(2):108-13. — View Citation

Anderson SI, Whatling P, Hudlicka O, Gosling P, Simms M, Brown MD. Chronic transcutaneous electrical stimulation of calf muscles improves functional capacity without inducing systemic inflammation in claudicants. Eur J Vasc Endovasc Surg. 2004 Feb;27(2):201-9. — View Citation

Andreozzi GM, Leone A, Laudani R, Deinite G, Martini R. Acute impairment of the endothelial function by maximal treadmill exercise in patients with intermittent claudication, and its improvement after supervised physical training. Int Angiol. 2007 Mar;26(1):12-7. — View Citation

Askew CD, Green S, Walker PJ, Kerr GK, Green AA, Williams AD, Febbraio MA. Skeletal muscle phenotype is associated with exercise tolerance in patients with peripheral arterial disease. J Vasc Surg. 2005 May;41(5):802-7. — View Citation

Atkins LM, Gardner AW. The relationship between lower extremity functional strength and severity of peripheral arterial disease. Angiology. 2004 Jul-Aug;55(4):347-55. — View Citation

Bendermacher BL, Willigendael EM, Teijink JA, Prins MH. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005263. Review. Update in: Cochrane Database Syst Rev. 2013;8:CD005263. — View Citation

Black CD, Elder CP, Gorgey A, Dudley GA. High specific torque is related to lengthening contraction-induced skeletal muscle injury. J Appl Physiol (1985). 2008 Mar;104(3):639-47. — View Citation

Campeau L, Enjalbert M, Lespérance J, Bourassa MG, Kwiterovich P Jr, Wacholder S, Sniderman A. The relation of risk factors to the development of atherosclerosis in saphenous-vein bypass grafts and the progression of disease in the native circulation. A study 10 years after aortocoronary bypass surgery. N Engl J Med. 1984 Nov 22;311(21):1329-32. — View Citation

Chi YW, Jaff MR. Optimal risk factor modification and medical management of the patient with peripheral arterial disease. Catheter Cardiovasc Interv. 2008 Mar 1;71(4):475-89. doi: 10.1002/ccd.21401. Review. — View Citation

Egginton S, Hudlická O. Selective long-term electrical stimulation of fast glycolytic fibres increases capillary supply but not oxidative enzyme activity in rat skeletal muscles. Exp Physiol. 2000 Sep;85(5):567-73. — View Citation

European Stroke Organisation., Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clément D, Collet JP, Cremonesi A, De Carlo M, Erbel R, Fowkes FG, Heras M, Kownator S, Minar E, Ostergren J, Poldermans D, Riambau V, Roffi M, Röther J, Sievert H, van Sambeek M, Zeller T; ESC Committee for Practice Guidelines.. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011 Nov;32(22):2851-906. doi: 10.1093/eurheartj/ehr211. — View Citation

Garcia LA. Epidemiology and pathophysiology of lower extremity peripheral arterial disease. J Endovasc Ther. 2006 Feb;13 Suppl 2:II3-9. Review. — View Citation

Gardner AW, Killewich LA, Montgomery PS, Katzel LI. Response to exercise rehabilitation in smoking and nonsmoking patients with intermittent claudication. J Vasc Surg. 2004 Mar;39(3):531-8. — View Citation

Gardner AW, Montgomery PS, Afaq A. Exercise performance in patients with peripheral arterial disease who have different types of exertional leg pain. J Vasc Surg. 2007 Jul;46(1):79-86. — View Citation

Garg PK, Tian L, Criqui MH, Liu K, Ferrucci L, Guralnik JM, Tan J, McDermott MM. Physical activity during daily life and mortality in patients with peripheral arterial disease. Circulation. 2006 Jul 18;114(3):242-8. — View Citation

Green HJ, Pette D. Early metabolic adaptations of rabbit fast-twitch muscle to chronic low-frequency stimulation. Eur J Appl Physiol Occup Physiol. 1997;75(5):418-24. — View Citation

Hamilton MT, Booth FW. Skeletal muscle adaptation to exercise: a century of progress. J Appl Physiol (1985). 2000 Jan;88(1):327-31. — View Citation

Hiatt WR, Wolfel EE, Meier RH, Regensteiner JG. Superiority of treadmill walking exercise versus strength training for patients with peripheral arterial disease. Implications for the mechanism of the training response. Circulation. 1994 Oct;90(4):1866-74. — View Citation

Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. — View Citation

Hortobágyi T, Dempsey L, Fraser D, Zheng D, Hamilton G, Lambert J, Dohm L. Changes in muscle strength, muscle fibre size and myofibrillar gene expression after immobilization and retraining in humans. J Physiol. 2000 Apr 1;524 Pt 1:293-304. — View Citation

Hudlicka O, Milkiewicz M, Cotter MA, Brown MD. Hypoxia and expression of VEGF-A protein in relation to capillary growth in electrically stimulated rat and rabbit skeletal muscles. Exp Physiol. 2002 May;87(3):373-81. — View Citation

Kelsall CJ, Brown MD, Kent J, Kloehn M, Hudlicka O. Arteriolar endothelial dysfunction is restored in ischaemic muscles by chronic electrical stimulation. J Vasc Res. 2004 May-Jun;41(3):241-51. — View Citation

Kruidenier LM, Viechtbauer W, Nicolaï SP, Büller H, Prins MH, Teijink JA. Treatment for intermittent claudication and the effects on walking distance and quality of life. Vascular. 2012 Feb;20(1):20-35. doi: 10.1258/vasc.2011.ra0048. Review. — View Citation

Kullo IJ, Bailey KR, Kardia SL, Mosley TH Jr, Boerwinkle E, Turner ST. Ethnic differences in peripheral arterial disease in the NHLBI Genetic Epidemiology Network of Arteriopathy (GENOA) study. Vasc Med. 2003 Nov;8(4):237-42. — View Citation

Lee HL, Mehta T, Ray B, Heng MS, McCollum PT, Chetter IC. A non-randomised controlled trial of the clinical and cost effectiveness of a Supervised Exercise Programme for claudication. Eur J Vasc Endovasc Surg. 2007 Feb;33(2):202-7. — View Citation

Makdisse M, Pereira Ada C, Brasil Dde P, Borges JL, Machado-Coelho GL, Krieger JE, Nascimento Neto RM, Chagas AC; Hearts of Brazil Study and Peripheral Arterial Disease Committee of the Brazilian Society of Cardiology/Funcor.. Prevalence and risk factors associated with peripheral arterial disease in the Hearts of Brazil Project. Arq Bras Cardiol. 2008 Dec;91(6):370-82. — View Citation

McDermott MM, Ades P, Guralnik JM, Dyer A, Ferrucci L, Liu K, Nelson M, Lloyd-Jones D, Van Horn L, Garside D, Kibbe M, Domanchuk K, Stein JH, Liao Y, Tao H, Green D, Pearce WH, Schneider JR, McPherson D, Laing ST, McCarthy WJ, Shroff A, Criqui MH. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. JAMA. 2009 Jan 14;301(2):165-74. doi: 10.1001/jama.2008.962. Erratum in: JAMA. 2012 Apr 25;307(16):1694. — View Citation

McDermott MM, Guralnik JM, Albay M, Bandinelli S, Miniati B, Ferrucci L. Impairments of muscles and nerves associated with peripheral arterial disease and their relationship with lower extremity functioning: the InCHIANTI Study. J Am Geriatr Soc. 2004 Mar;52(3):405-10. — View Citation

McGuigan MR, Bronks R, Newton RU, Sharman MJ, Graham JC, Cody DV, Kraemer WJ. Resistance training in patients with peripheral arterial disease: effects on myosin isoforms, fiber type distribution, and capillary supply to skeletal muscle. J Gerontol A Biol Sci Med Sci. 2001 Jul;56(7):B302-10. — View Citation

Milkiewicz M, Hudlicka O, Verhaeg J, Egginton S, Brown MD. Differential expression of Flk-1 and Flt-1 in rat skeletal muscle in response to chronic ischaemia: favourable effect of muscle activity. Clin Sci (Lond). 2003 Oct;105(4):473-82. — View Citation

Monahan KD, Tanaka H, Dinenno FA, Seals DR. Central arterial compliance is associated with age- and habitual exercise-related differences in cardiovagal baroreflex sensitivity. Circulation. 2001 Oct 2;104(14):1627-32. — View Citation

Murphy TP, Hirsch AT, Ricotta JJ, Cutlip DE, Mohler E, Regensteiner JG, Comerota AJ, Cohen DJ; CLEVER Steering Committee.. The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods. J Vasc Surg. 2008 Jun;47(6):1356-63. doi: 10.1016/j.jvs.2007.12.048. — View Citation

Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group.. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007 Jan;45 Suppl S:S5-67. — View Citation

Parmenter BJ, Raymond J, Dinnen P, Singh MA. A systematic review of randomized controlled trials: Walking versus alternative exercise prescription as treatment for intermittent claudication. Atherosclerosis. 2011 Sep;218(1):1-12. doi: 10.1016/j.atherosclerosis.2011.04.024. Review. — View Citation

Parmenter BJ, Raymond J, Dinnen PJ, Lusby RJ, Fiatarone Singh MA. Preliminary evidence that low ankle-brachial index is associated with reduced bilateral hip extensor strength and functional mobility in peripheral arterial disease. J Vasc Surg. 2013 Apr;57(4):963-973.e1. doi: 10.1016/j.jvs.2012.08.103. — View Citation

Parmenter BJ, Raymond J, Fiatarone Singh MA. The effect of exercise on fitness and performance-based tests of function in intermittent claudication: a systematic review. Sports Med. 2013 Jun;43(6):513-24. doi: 10.1007/s40279-013-0038-9. Review. — View Citation

Parr BM, Noakes TD, Derman EW. Peripheral arterial disease and intermittent claudication: efficacy of short-term upper body strength training, dynamic exercise training, and advice to exercise at home. S Afr Med J. 2009 Nov;99(11):800-4. — View Citation

Presern-Strukelj M, Poredos P. The influence of electrostimulation on the circulation of the remaining leg in patients with one-sided amputation. Angiology. 2002 May-Jun;53(3):329-35. — View Citation

Rabkin SW, Chan SH, Sweeney C. Ankle-brachial index as an indicator of arterial stiffness in patients without peripheral artery disease. Angiology. 2012 Feb;63(2):150-4. doi: 10.1177/0003319711410307. — View Citation

Ratliff DA, Puttick M, Libertiny G, Hicks RC, Earby LE, Richards T. Supervised exercise training for intermittent claudication: lasting benefit at three years. Eur J Vasc Endovasc Surg. 2007 Sep;34(3):322-6. — View Citation

Regensteiner JG, Wolfel EE, Brass EP, Carry MR, Ringel SP, Hargarten ME, Stamm ER, Hiatt WR. Chronic changes in skeletal muscle histology and function in peripheral arterial disease. Circulation. 1993 Feb;87(2):413-21. — View Citation

Roberts AJ, Roberts EB, Sykes K, De Cossart L, Edwards P, Cotterrell D. Physiological and functional impact of an unsupervised but supported exercise programme for claudicants. Eur J Vasc Endovasc Surg. 2008 Sep;36(3):319-24. doi: 10.1016/j.ejvs.2008.04.008. — View Citation

Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. Erratum in: J Vasc Surg 2001 Apr;33(4):805. — View Citation

Scott-Okafor HR, Silver KK, Parker J, Almy-Albert T, Gardner AW. Lower extremity strength deficits in peripheral arterial occlusive disease patients with intermittent claudication. Angiology. 2001 Jan;52(1):7-14. — View Citation

Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999-2000. Circulation. 2004 Aug 10;110(6):738-43. — View Citation

Skorjanc D, Jaschinski F, Heine G, Pette D. Sequential increases in capillarization and mitochondrial enzymes in low-frequency-stimulated rabbit muscle. Am J Physiol. 1998 Mar;274(3 Pt 1):C810-8. — View Citation

Smart NA, Dieberg G, Giallauria F. Functional electrical stimulation for chronic heart failure: a meta-analysis. Int J Cardiol. 2013 Jul 15;167(1):80-6. doi: 10.1016/j.ijcard.2011.12.019. Review. — View Citation

Treesak C, Kasemsup V, Treat-Jacobson D, Nyman JA, Hirsch AT. Cost-effectiveness of exercise training to improve claudication symptoms in patients with peripheral arterial disease. Vasc Med. 2004 Nov;9(4):279-85. — View Citation

Vivodtzev I, Debigaré R, Gagnon P, Mainguy V, Saey D, Dubé A, Paré MÈ, Bélanger M, Maltais F. Functional and muscular effects of neuromuscular electrical stimulation in patients with severe COPD: a randomized clinical trial. Chest. 2012 Mar;141(3):716-25. doi: 10.1378/chest.11-0839. — View Citation

Wang J, Zhou S, Bronks R, Graham J, Myers S. Effects of supervised treadmill walking training on calf muscle capillarization in patients with intermittent claudication. Angiology. 2009 Feb-Mar;60(1):36-41. doi: 10.1177/0003319708317337. — View Citation

Watson NL, Sutton-Tyrrell K, Youk AO, Boudreau RM, Mackey RH, Simonsick EM, Rosano C, Hardy SE, Windham BG, Harris TB, Najjar SS, Lakatta EG, Atkinson HH, Johnson KC, Bauer DC, Newman AB; Health ABC Study.. Arterial stiffness and gait speed in older adults with and without peripheral arterial disease. Am J Hypertens. 2011 Jan;24(1):90-5. doi: 10.1038/ajh.2010.193. Erratum in: Am J Hypertens. 2011 Feb;24(2):248. Nemwan, Anne B [corrected to Newman, Anne B]. — View Citation

Zwierska I, Walker RD, Choksy SA, Male JS, Pockley AG, Saxton JM. Upper- vs lower-limb aerobic exercise rehabilitation in patients with symptomatic peripheral arterial disease: a randomized controlled trial. J Vasc Surg. 2005 Dec;42(6):1122-30. — View Citation

* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiopulmonary exercise test	assess functional capacity	13 months
Secondary	WHOQOL Questionnaire	asses quality of life	13 months
Secondary	Brachial ultrasonography	endothelial function	13 months
Secondary	Analog scale of pain	assess pain intensity	13 months
Secondary	Repetition maximum strength test (1RM)	assess Muscle strengh	13 months