- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03092336
Effects of Different Protocols of Physical Training on Levels of Muscle Strength and Functional Capacity
March 21, 2017 updated by: Hospital de Clinicas de Porto Alegre
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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
Study Type
Interventional
Enrollment (Anticipated)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Márcio Garcia, MD
- Phone Number: 05551597634
- Email: mgmarciogarcia@gmail.com
Study Contact Backup
- Name: Rosane M Nery, PhD
- Phone Number: 0555133597634
- Email: rosane.nery@gmail.com
Study Locations
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90640030
- Recruiting
- Hospital de Clinicas de Porto Alegre
-
Contact:
- Rosane M Nery, PhD
- Phone Number: 0555133597634
- Email: rosane.nery@gmail.com
-
Contact:
- Márcio Garcia, MD
- Phone Number: 0555133597434
- Email: mgmarciogarcia@gmail.com
-
Principal Investigator:
- Antonio C Santos, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electrical Stimulation
The training with electrostimulation will be performed with the following intensity: Medium frequency current: 2.500Hz Modulation frequency: up to 50Hz Time on / off: 1: 2 Average session time 10 to 15 min Being applied in the same muscle groups that will be trained in the group that will perform strength training. |
electrical stimulation training
|
Experimental: Strength training
There will be 10 exercises: upper limbs: Supine with dumbbells; High pulley pull; Alternating thread with dumbbells; Triceps dumbbell test; Lower limbs: knee extensor, squatting with body weight, plantar flexion, knee flexion and plantar dorsiflexion.
The session time will be from 45 minutes to one hour 2 times weekly totaling at the end of the 12 weeks, 24 strength training sessions.
|
strength training group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cardiopulmonary exercise test
Time Frame: 13 months
|
assess functional capacity
|
13 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WHOQOL Questionnaire
Time Frame: 13 months
|
asses quality of life
|
13 months
|
Brachial ultrasonography
Time Frame: 13 months
|
endothelial function
|
13 months
|
Analog scale of pain
Time Frame: 13 months
|
assess pain intensity
|
13 months
|
Repetition maximum strength test (1RM)
Time Frame: 13 months
|
assess Muscle strengh
|
13 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Antonio C Santos, PhD, Hospital de Clinicas de Porto Alegre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1161/01.CIR.0000137913.26087.F0. Epub 2004 Jul 19.
- Garcia LA. Epidemiology and pathophysiology of lower extremity peripheral arterial disease. J Endovasc Ther. 2006 Feb;13 Suppl 2:II3-9. doi: 10.1177/15266028060130S204.
- 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. doi: 10.1016/j.jvs.2006.12.037. No abstract available.
- 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. doi: 10.1016/s0741-5214(97)70045-4. Erratum In: J Vasc Surg 2001 Apr;33(4):805.
- 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. Epub 2011 Jun 15.
- 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. doi: 10.1001/jama.286.11.1317.
- 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. doi: 10.1016/j.jvs.2003.08.037.
- Hortobagyi 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(Pt 1):293-304. doi: 10.1111/j.1469-7793.2000.00293.x.
- 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.
- 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. doi: 10.1093/gerona/56.7.b302.
- Campeau L, Enjalbert M, Lesperance 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. doi: 10.1056/NEJM198411223112101.
- 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. doi: 10.1016/j.jvs.2007.02.037. Epub 2007 May 30.
- 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.
- 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. doi: 10.1590/s0066-782x2008001800008.
- 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. doi: 10.1191/1358863x03vm511oa.
- 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. doi: 10.1161/CIRCULATIONAHA.105.605246. Epub 2006 Jul 3.
- 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. doi: 10.1016/j.jvs.2005.01.037.
- 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. doi: 10.1002/14651858.CD005263.pub2.
- 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. Epub 2008 Apr 25.
- 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.
- European Stroke Organisation; Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clement 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, Rother 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. Epub 2011 Aug 26. No abstract available.
- 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. doi: 10.1191/1358863x04vm570oa.
- 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.
- 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. doi: 10.1161/01.cir.90.4.1866.
- 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.
- 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. doi: 10.1016/j.ejvs.2003.10.003.
- 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. doi: 10.1159/000078301. Epub 2004 Apr 30.
- 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. doi: 10.1177/000331970205300311.
- 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. doi: 10.1016/j.jvs.2005.08.021.
- 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. doi: 10.1016/j.ejvs.2007.04.014. Epub 2007 Jun 22.
- 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. Epub 2010 Sep 9. Erratum In: Am J Hypertens. 2011 Feb;24(2):248. Nemwan, Anne B [corrected to Newman, Anne B].
- 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. doi: 10.1161/hc3901.096670.
- 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. Epub 2011 May 5.
- 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.
- Kruidenier LM, Viechtbauer W, Nicolai SP, Buller 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. Epub 2012 Jan 23.
- 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. doi: 10.1016/j.jvn.2006.03.002.
- 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. doi: 10.1016/j.ejvs.2006.08.005. Epub 2006 Dec 4.
- 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. Epub 2008 May 27.
- 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. Epub 2008 Jun 10.
- 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. doi: 10.1177/000331970405500401.
- 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. doi: 10.1111/j.1532-5415.2004.52113.x.
- 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. doi: 10.1177/000331970105200102.
- 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. doi: 10.1161/01.cir.87.2.413.
- 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. Epub 2012 Dec 14.
- 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. Epub 2012 Jan 10.
- Vivodtzev I, Debigare R, Gagnon P, Mainguy V, Saey D, Dube A, Pare ME, Belanger 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):716-725. doi: 10.1378/chest.11-0839. Epub 2011 Nov 23.
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- 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. doi: 10.1007/s004210050182.
- 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):C810-8. doi: 10.1152/ajpcell.1998.274.3.C810.
- 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. doi: 10.1113/eph8702285.
- 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. doi: 10.1042/CS20030035.
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Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2011
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
March 1, 2018
Study Registration Dates
First Submitted
March 21, 2017
First Submitted That Met QC Criteria
March 21, 2017
First Posted (Actual)
March 27, 2017
Study Record Updates
Last Update Posted (Actual)
March 27, 2017
Last Update Submitted That Met QC Criteria
March 21, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-0566
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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