The treadmill is a better functional test than the 6-minute walk test in therapeutic trials of patients with peripheral artery disease

Circulation

Volumn 130, Issue 1, 2014, Pages 69-78

  Hiatt, William R ^a   Rogers, R Kevin ^a   Brass, Eric P ^b  

^a UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^b HARBOR UCLA MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); DAILY LIFE ACTIVITY; ENDURANCE; HUMAN; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PHYSICAL ACTIVITY; PRIORITY JOURNAL; QUALITY OF LIFE; RESTING METABOLIC RATE; TREADMILL TEST;

ACTIVITIES OF DAILY LIVING; BIOLOGICAL MARKERS; CLINICAL TRIALS AS TOPIC; EXERCISE TEST; HUMANS; INTERMITTENT CLAUDICATION; LEG; OXIDATIVE STRESS; PERIPHERAL ARTERIAL DISEASE; PHYSICAL ENDURANCE; QUALITY OF LIFE; REPRODUCIBILITY OF RESULTS; TREATMENT OUTCOME; WALKING;

EID: 84903727088     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.113.007003     Document Type: Article

References (69)

1. McDermott MM, Liu K, Guralnik JM, Martin GJ, Criqui MH, Greenland P. Measurement of walking endurance and walking velocity with questionnaire: validation of the walking impairment questionnaire in men and women with peripheral arterial disease. J Vasc Surg. 1998;28:1072-1081. (Pubitemid 28562712)
2. Sieminski DJ, Gardner AW. The relationship between free-living daily physical activity and the severity of peripheral arterial occlusive disease. Vasc Med. 1997;2:286-291. (Pubitemid 28212094)
3. Regensteiner JG, Steiner JF, Panzer RJ, Hiatt WR. Evaluation of walking impairment by questionnaire in patients with peripheral arterial disease. J Vasc Med Biol. 1990;2:142-152.
4. McDermott MM, Mehta S, Greenland P. Exertional leg symptoms other than intermittent claudication are common in peripheral arterial disease. Arch Intern Med. 1999;159:387-392. (Pubitemid 29091628)
5. McDermott MM, Greenland P, Liu K, Guralnik JM, Criqui MH, Dolan NC, Chan C, Celic L, Pearce WH, Schneider JR, Sharma L, Clark E, Gibson D, Martin GJ. Leg symptoms in peripheral arterial disease: associated clinical characteristics and functional impairment. JAMA. 2001;286:1599-1606. (Pubitemid 33010284)
6. Hiatt WR, Nawaz D, Regensteiner JG, Hossack KF. The evaluation of exercise performance in patients with peripheral vascular disease. J Cardiopulm Rehabil. 1988;12:525-532. (Pubitemid 19060132)
7. Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ, O'Brien WL, Bassett DR Jr, Schmitz KH, Emplaincourt PO, Jacobs DR Jr, Leon AS. Compendium of physical activities: an update of activity codes and MET intensities. Med Sci Sports Exerc. 2000;32(suppl):S498-S504.
8. Leon AS, Jacobs DR Jr, DeBacker G, Taylor HL. Relationship of physical characteristics and life habits to treadmill exercise capacity. Am J Epidemiol. 1981;113:653-660. (Pubitemid 11065965)
9. Brass EP, Hiatt WR, Green S. Skeletal muscle metabolic changes in peripheral arterial disease contribute to exercise intolerance: a point-counterpoint discussion. Vasc Med. 2004;9:293-301. (Pubitemid 40202246)
10. Wasserman K. Coupling of external to cellular respiration during exercise: the wisdom of the body revisited. Am J Physiol. 1994;266(pt 1):E519-E539.
11. Turner DL, Hoppeler H, Claassen H, Vock P, Kayser B, Schena F, Ferretti G. Effects of endurance training on oxidative capacity and structural composition of human arm and leg muscles. Acta Physiol Scand. 1997;161:459-464. (Pubitemid 27515835)
12. Tonkonogi M, Sahlin K. Physical exercise and mitochondrial function in human skeletal muscle. Exerc Sport Sci Rev. 2002;30:129-137. (Pubitemid 34787300)
13. Wagner PD. Determinants of maximal oxygen transport and utilization. Annu Rev Physiol. 1996;58:21-50. (Pubitemid 26106712)
14. Brass EP. Intermittent claudication: new targets for drug development. Drugs. 2013;73:999-1014.
15. Muller MD, Reed AB, Leuenberger UA, Sinoway LI. Physiology in medicine: peripheral arterial disease. J Appl Physiol (1985). 2013;115:1219-1226.
16. Lassen NA, Kampp M. Calf muscle blood flow during walking studied by the xe-133 method in normals and in patients with intermittent claudication. Scand J Clin Lab Invest. 1965;17:447-453.
17. Brevetti G, Giugliano G, Brevetti L, Hiatt WR. Inflammation in peripheral artery disease. Circulation. 2010;122:1862-1875.
18. Brass EP, Hiatt WR, Gardner AW, Hoppel CL. Decreased NADH dehydrogenase and ubiquinol-cytochrome c oxidoreductase in peripheral arterial disease. Am J Physiol. 2001;280:H603-H609.
19. Hiatt WR, Wolfel EE, Regensteiner JG, Brass EP. Skeletal muscle carnitine metabolism in patients with unilateral peripheral arterial disease. J Appl Physiol (1985). 1992;73:346-353.
20. 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;90:1866-1874. (Pubitemid 24320937)
21. Hiatt WR, Regensteiner JG, Hargarten ME, Wolfel EE, Brass EP. Benefit of exercise conditioning for patients with peripheral arterial disease. Circulation. 1990;81:602-609. (Pubitemid 20055969)
22. Hiatt WR, Regensteiner JG, Wolfel EE, Carry MR, Brass EP. Effect of exercise training on skeletal muscle histology and metabolism in peripheral arterial disease. J Appl Physiol (1985). 1996;81:780-788.
23. Robbins JL, Jones WS, Duscha BD, Allen JD, Kraus WE, Regensteiner JG, Hiatt WR, Annex BH. Relationship between leg muscle capillary density and peak hyperemic blood flow with endurance capacity in peripheral artery disease. J Appl Physiol (1985). 2011;111:81-86.
24. Pernow B, Saltin B, Wahren J, Cronestrand R, Ekestroöm S. Leg blood flow and muscle metabolism in occlusive arterial disease of the leg before and after reconstructive surgery. Clin Sci Mol Med. 1975;49:265-275. (Pubitemid 8082737)
25. Regensteiner JG, Steiner JF, Hiatt WR. Exercise training improves functional status in patients with peripheral arterial disease. J Vasc Surg. 1996;23:104-115. (Pubitemid 26037967)
26. Regensteiner JG, Ware JE Jr, McCarthy WJ, Zhang P, Forbes WP, Heckman J, Hiatt WR. Effect of cilostazol on treadmill walking, community-based walking ability, and health-related quality of life in patients with intermittent claudication due to peripheral arterial disease: meta-analysis of six randomized controlled trials. J Am Geriatr Soc. 2002;50:1939-1946. (Pubitemid 35462438)
27. Cohen J. Statistical Power Analyses for the Behavoioral Sciences. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.
28. Brass EP, Hiatt WR. Review of mortality and cardiovascular event rates in patients enrolled in clinical trials for claudication therapies. Vasc Med. 2006;11:141-145. (Pubitemid 46099257)
29. Casaburi R. A primer in cardiopulmonary exercise testing. Monaldi Arch Chest.Dis. 1993;48:266-271. (Pubitemid 23288189)
30. Degischer S, Labs KH, Aschwanden M, Tschoepl M, Jaeger KA. Reproducibility of constant-load treadmill testing with various treadmill protocols and predictability of treadmill test results in patients with intermittent claudication. J Vasc Surg. 2002;36:83-88. (Pubitemid 41122893)
31. Hiatt WR, Hirsch AT, Regensteiner JG, Brass EP. Clinical trials for claudication: assessment of exercise performance, functional status, and clinical end points: Vascular Clinical Trialists. Circulation. 1995;92:614-621.
32. Gardner AW, Skinner JS, Cantwell BW, Smith LK. Progressive vs singlestage treadmill tests for evaluation of claudication. Med Sci Sports Exerc. 1991;23:402-408.
33. Hiatt WR, Goldstone J, Smith SC, Jr., McDermott M, Moneta G, Oka R, Newman AB, Pearce WH. Atherosclerotic Peripheral Vascular Disease Symposium II: nomenclature for vascular diseases. Circulation. 2008;118:2826-2829.
34. Hansen JE, Sue DY, Oren A, Wasserman K. Relation of oxygen uptake to work rate in normal men and men with circulatory disorders. Am J Cardiol. 1987;59:669-674. (Pubitemid 17047341)
35. Bruce RA, Kusumi F, Hosmer D. Maximal oxygen intake and nomographic assessment of functional aerobic impairment in cardiovascular disease. Am Heart J. 1973;85:546-562.
36. Bruce RA. Exercise testing of patients with coronary heart disease: principles and normal standards for evaluation. Ann Clin Res. 1971;3:323-332.
37. Brass EP, Cooper LT, Morgan RE, Hiatt WR. A phase II dose-ranging study of the phosphodiesterase inhibitor K-134 in patients with peripheral artery disease and claudication. J Vasc Surg. 2012;55:381-389.e1.
38. Hiatt WR, Cox L, Greenwalt M, Griffin A, Schechter C. Quality of the assessment of primary and secondary endpoints in claudication and critical leg ischemia trials. Vasc Med. 2005;10:207-213. (Pubitemid 41479675)
39. N icolaï SP, Viechtbauer W, Kruidenier LM, Candel MJ, Prins MH, Teijink JA. Reliability of treadmill testing in peripheral arterial disease: a metaregression analysis. J Vasc Surg. 2009;50:322-329.
40. Labs KH, Nehler MR, Roessner M, Jaeger KA, Hiatt WR. Reliability of treadmill testing in peripheral arterial disease: a comparison of a constant load with a graded load treadmill protocol. Vasc Med. 1999;4:239-246. (Pubitemid 30010575)
41. Brass EP, Jiao J, Hiatt W. Optimal assessment of baseline treadmill walking performance in claudication clinical trials. Vasc Med. 2007;12:97-103.
42. Porter JM, Cutler BS, Lee BY, Reich T, Reichle FA, Scogin JT, Strandness DE. Pentoxifylline efficacy in the treatment of intermittent claudication: multicenter controlled double-blind trial with objective assessment of chronic occlusive arterial disease patients. Am Heart J. 1982;104:66-72. (Pubitemid 13114585)
43. Skinner JS, Strandness DE Jr. Exercise and intermittent claudication, I: effect of repetition and intensity of exercise. Circulation. 1967;36:15-22.
44. Brass EP, Anthony R, Cobb FR, Koda I, Jiao J, Hiatt WR. The novel phosphodiesterase inhibitor NM-702 improves claudication-limited exercise performance in patients with peripheral arterial disease. J Am Coll Cardiol. 2006;48:2539-2545. (Pubitemid 44881218)
45. Regensteiner JG, Hargarten ME, Rutherford RB, Hiatt WR. Functional benefits of peripheral vascular bypass surgery for patients with intermittent claudication. Angiology. 1993;44:1-10. (Pubitemid 23033195)
46. Murphy TP, Cutlip DE, Regensteiner JG, Mohler ER, Cohen DJ, Reynolds MR, Massaro JM, Lewis BA, Cerezo J, Oldenburg NC, Thum CC, Goldberg S, Jaff MR, Steffes MW, Comerota AJ, Ehrman J, Treat- Jacobson D, Walsh ME, Collins T, Badenhop DT, Bronas U, Hirsch AT. Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) Study. Circulation. 2012;125:130-139.
47. Brass EP, Koster D, Hiatt WR, Amato A. A systematic review and metaanalysis of propionyl-L-carnitine effects on exercise performance in patients with claudication. Vasc Med. 2013;18:3-12.
48. N icolaï SP, Kruidenier LM, Rouwet EV, Graffius K, Prins MH, Teijink JA. The walking impairment questionnaire: an effective tool to assess the effect of treatment in patients with intermittent claudication. J Vasc Surg. 2009;50:89-94.
49. Murphy TP, Reynolds MR, Cohen DJ, Regensteiner JG, Massaro JM, Cutlip DE, Mohler ER, Cerezo J, Oldenburg NC, Thum CC, Goldberg S, Hirsch AT. Correlation of patient-reported symptom outcomes and treadmill test outcomes after treatment for aortoiliac claudication. J Vasc Interv Radiol. 2013;24:1427-1435.
50. Le Faucheur A, Abraham P, Jaquinandi V, Bouyé P, Saumet JL, Noury- Desvaux B. Measurement of walking distance and speed in patients with peripheral arterial disease: a novel method using a global positioning system. Circulation. 2008;117:897-904. (Pubitemid 351272587)
51. Committee for Proprietary Medical Products (CPMP). Note for guidance on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease. http://www.ema.europa.eu/docs/en-GB/document- library/Scientific-guideline/2009/09/WC500003341.pdf. Accessed April 1, 2014.
52. Labs KH, Dormandy JA, Jaeger KA, Stuerzebecher C, Hiatt WR. Trans- Atlantic Conference on Clinical Trial Guidelines in PAOD (peripheral arterial occlusive disease) clinical trial methodology. Eur J Vasc Endovasc Surg. 1999;18:253-265. (Pubitemid 29431351)
53. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002;166:111-117.
54. Solway S, Brooks D, Lacasse Y, Thomas S. A qualitative systematic overview of the measurement properties of functional walk tests used in the cardiorespiratory domain. Chest. 2001;119:256-270. (Pubitemid 32150576)
55. Redelmeier DA, Bayoumi AM, Goldstein RS, Guyatt GH. Interpreting small differences in functional status: the six minute walk test in chronic lung disease patients. Am J Respir Crit Care Med. 1997;155:1278-1282. (Pubitemid 27172771)
56. Bittner V, Weiner DH, Yusuf S, Rogers WJ, McIntyre KM, Bangdiwala SI, Kronenberg MW, Kostis JB, Kohn RM, Guillotte M. Prediction of mortality and morbidity with a 6-minute walk test in patients with left ventricular dysfunction: SOLVD Investigators. JAMA. 1993;270:1702-1707. (Pubitemid 23295315)
57. Montgomery PS, Gardner AW. The clinical utility of a six-minute walk test in peripheral arterial occlusive disease patients. J Am Geriatr Soc. 1998;46:706-711. (Pubitemid 28262345)
58. Beekman E, Mesters I, Hendriks EJ, Klaassen MP, Gosselink R, van Schayck OC, de Bie RA. Course length of 30 metres versus 10 metres has a significant influence on six-minute walk distance in patients with COPD: an experimental crossover study. J Physiother. 2013;59:169-176.
59. Chandra D, Wise RA, Kulkarni HS, Benzo RP, Criner G, Make B, Slivka WA, Ries AL, Reilly JJ, Martinez FJ, Sciurba FC. Optimizing the six minute walk test as a measure of exercise capacity in COPD. Chest. 2012;142:1545-1552.
60. Jenkins S, Cecins NM. Six-minute walk test in pulmonary rehabilitation: do all patients need a practice test? Respirology. 2010;15:1192-1196.
61. Polkey MI, Spruit MA, Edwards LD, Watkins ML, Pinto-Plata V, Vestbo J, Calverley PM, Tal-Singer R, Agusti A, Bakke PS, Coxson HO, Lomas DA, MacNee W, Rennard S, Silverman EK, Miller BE, Crim C, Yates J, Wouters EF, Celli B. Six-minute-walk test in chronic obstructive pulmonary disease: minimal clinically important difference for death or hospitalization. Am J Respir Crit Care Med. 2013;187:382-386.
62. Hanson LC, McBurney H, Taylor NF. The retest reliability of the six-minute walk test in patients referred to a cardiac rehabilitation programme. Physiother Res Int. 2012;17:55-61.
63. Kervio G, Ville NS, Leclercq C, Daubert JC, Carré F. Intensity and daily reliability of the six-minute walk test in moderate chronic heart failure patients. Arch Phys Med Rehabil. 2004;85:1513-1518. (Pubitemid 39221095)
64. Shoemaker MJ, Curtis AB, Vangsnes E, Dickinson MG. Clinically meaningful change estimates for the six-minute walk test and daily activity in individuals with chronic heart failure. Cardiopulm Phys Ther J. 2013;24:21-29.
65. McDermott MM, Guralnik JM, Ferrucci L, Criqui MH, Greenland P, Tian L, Liu K, Tan J. Functional decline in lower-extremity peripheral arterial disease: associations with comorbidity, gender, and race. J Vasc Surg. 2005;42:1131-1137. (Pubitemid 41817167)
66. McDermott MM, Liu K, Guralnik JM, Ferrucci L, Green D, Greenland P, Tian L, Criqui MH, Lo C, Rifai N, Ridker PM, Zheng J, Pearce W. Functional decline in patients with and without peripheral arterial disease: predictive value of annual changes in levels of C-reactive protein and D-dimer. J Gerontol A Biol Sci Med Sci. 2006;61:374-379.
67. 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;301:165-174.
68. McDermott MM, Liu K, Guralnik JM, Criqui MH, Spring B, Tian L, Domanchuk K, Ferrucci L, Lloyd-Jones D, Kibbe M, Tao H, Zhao L, Liao Y, Rejeski WJ. Home-based walking exercise intervention in peripheral artery disease: a randomized clinical trial. JAMA. 2013;310:57-65.
69. Jaff MR, Dale RA, Creager MA, Lipicky RJ, Constant J, Campbell LA, Hiatt WR. Anti-chlamydial antibiotic therapy for symptom improvement in peripheral artery disease: prospective evaluation of rifalazil effect on vascular symptoms of intermittent claudication and other endpoints in Chlamydia pneumoniae seropositive patients (PROVIDENCE-1). Circulation. 2009;119:452-458.