Effekter af forskellige protokoller for fysisk træning på niveauer af muskelstyrke og funktionel kapacitet
21. marts 2017 opdateret af: Hospital de Clinicas de Porto Alegre
Effekter af forskellige protokoller for fysisk træning på niveauer af muskelstyrke og funktionel kapacitet på patienter med perifer arteriesygdom: et randomiseret klinisk forsøg
Introduktion: Perifer obstruktiv arteriel sygdom er en tilstand, der rammer omkring 15 % af verdensbefolkningen og blander sig i patienters muskelstyrke, livskvalitet og funktionsevne.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Studiemål: at vurdere tre metoder til fysisk træning (styrketræning, aerob træning og elektrisk stimuleringstræning) i muskelstyrke, funktionsevne og livskvalitet hos patienter med perifer obstruktiv arteriel sygdom
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
73
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90640030
- Rekruttering
- Hospital de Clínicas de Porto Alegre
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Kontakt:
- Rosane M Nery, PhD
- Telefonnummer: 0555133597634
- E-mail: rosane.nery@gmail.com
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Kontakt:
- Márcio Garcia, MD
- Telefonnummer: 0555133597434
- E-mail: mgmarciogarcia@gmail.com
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Ledende efterforsker:
- Antonio C Santos, PhD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Diagnose af PAD og IC.
- Alder fra 40 til 80 år.
- Etape I og II af Fontaine.
- Symptomer på intermitterende Claudication i mindst 3 måneder med hvilende brachial indeks ≤ 0,90 i 1 eller 2 ben
Ekskluderingskriterier:
- Kritisk iskæmi i en af underekstremiteterne.
- Moderate eller svære sår i en af underekstremiteterne. Ortopædiske problemer, der forhindrer træning eller evaluering.
- Deltagelse i andre undersøgelser med rehabilitering.
- Nedsat arteriel hypertension.
- Dekompenseret diabetes
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Elektrisk stimulering
Træningen med elektrostimulation vil blive udført med følgende intensitet: Mellemfrekvensstrøm: 2.500Hz Modulationsfrekvens: op til 50Hz Tid til/fra: 1:2 Gennemsnitlig sessionstid 10 til 15 min. Bliver påført i de samme muskelgrupper, som vil blive trænet i gruppen, der skal udføre styrketræning. |
elektrisk stimulationstræning
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Eksperimentel: Styrketræning
Der vil være 10 øvelser: Øvre lemmer: Rygliggende med håndvægte; Høj remskive træk; Skiftende tråd med håndvægte; Triceps håndvægt test; Nedre lemmer: knæekstensor, hugsiddende med kropsvægt, plantarfleksion, knæfleksion og plantar dorsalfleksion.
Sessionstiden vil være fra 45 minutter til en time 2 gange ugentligt, i alt ved slutningen af de 12 uger, 24 styrketræningssessioner.
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styrketræningsgruppe
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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kardiopulmonal træningstest
Tidsramme: 13 måneder
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vurdere funktionsevne
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13 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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WHOQOL spørgeskema
Tidsramme: 13 måneder
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vurderer livskvaliteten
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13 måneder
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Brachial ultralyd
Tidsramme: 13 måneder
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endotelfunktion
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13 måneder
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Analog smerteskala
Tidsramme: 13 måneder
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vurdere smertens intensitet
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13 måneder
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Gentagelse maksimal styrke test (1RM)
Tidsramme: 13 måneder
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vurdere muskelstyrke
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13 måneder
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Antonio C Santos, PhD, Hospital de Clínicas de Porto Alegre
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- 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.
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- 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.
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- 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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- 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.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2011
Primær færdiggørelse (Forventet)
1. marts 2018
Studieafslutning (Forventet)
1. marts 2018
Datoer for studieregistrering
Først indsendt
21. marts 2017
Først indsendt, der opfyldte QC-kriterier
21. marts 2017
Først opslået (Faktiske)
27. marts 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11-0566
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