Effects of exercise prescribed at different levels of claudication pain on walking performance in patients with intermittent claudication: a protocol for a randomised controlled trial

Stefan T Birkett, Jonathan Sinclair, Sally A Seed, Sean Pymer, Edward Caldow, Lee Ingle, Amy E Harwood, Anselm Egun, Stefan T Birkett, Jonathan Sinclair, Sally A Seed, Sean Pymer, Edward Caldow, Lee Ingle, Amy E Harwood, Anselm Egun

Abstract

Background: Peripheral artery disease affects over 236 million people globally and the classic symptom is intermittent claudication (IC) which is associated with reduction in physical activity. The evidence that supervised exercise programmes (SEPs) improve pain-free and maximal walking distance is irrefutable. However, adherence rates are low with exercise-related pain cited as a contributing factor. National and international guidelines recommend exercising at a moderate to maximal level of claudication pain to improve walking ability; however, exercising pain-free or at mild claudication pain has been shown to achieve this outcome. There is limited evidence that compares the relative effects of exercise prescribed at different levels of claudication pain.

Objective: The objective of this study is to directly compare the effects of exercise prescribed at three different levels of claudication pain on walking performance.

Design: This study will be a single-centre randomised controlled trial.

Methods: Based on an a priori power calculation, 51 patients with IC will be allocated to 24 weeks of twice-weekly pain-free (PF), moderate pain (MOD-P) or maximal pain (MAX-P) exercise. The PF group will cease exercise at the onset of claudication (1 on the 0-4 IC rating scale), the MOD-P group will stop once moderate pain is reached (2 on the rating scale) and the MAX-P group will stop once maximal pain is reached (4 on the rating scale).

Analysis: Outcome measures will be assessed at baseline, 12 and 24 weeks adopting an analysis of covariance (ANCOVA) to compare MWD across three time points. The primary outcome for the trial will be change in maximal treadmill walking distance at 12 and 24 weeks.

Registration: Trial registration number: NCT04370327.

Keywords: pain; peripheral artery disease; supervised exercise programme.

Conflict of interest statement

Conflict of interest statement: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Study flow chart.
Figure 2.
Figure 2.
Visual representation of the PAD-specific exercise circuit.
Figure 3.
Figure 3.
The Intermittent Claudication rating scale which will be used by the patients to grade claudication pain during the exercise intervention. Taken from AACPVR Guidelines for Cardiac Rehabilitation and Secondary Prevention Programs (2013).

References

    1. Hiatt WR. Medical treatment of peripheral arterial disease and claudication. N Engl J Med 2001; 344: 1608–1621.
    1. Song P, Rudan D, Zhu Y, et al.. Global, regional, and national prevalence and risk factors for peripheral artery disease in 2015: an updated systematic review and analysis. Lancet Glob Health 2019; 7: e1020–e1030.
    1. Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res 2015; 116: 1509–1526.
    1. Aboyans V, Ricco JB, Bartelink MEL, et al.. 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO) the task force for the diagnosis and treatment of peripheral arterial diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J 2018; 39: 763–816.
    1. Fowkes FG, Aboyans V, Fowkes FJ, et al.. Peripheral artery disease: epidemiology and global perspectives. Nat Rev Cardiol 2017; 14: 156–170.
    1. Gohil RA, Mockford KA, Mazari F, et al.. Balance impairment, physical ability, and its link with disease severity in patients with intermittent claudication. Ann Vasc Surg 2013; 27: 68–74.
    1. NICE. Peripheral arterial disease: diagnosis and management. Clinical Guidance No. 147. London: National Institute for Health and Care Excellence (NICE), 2012.
    1. NICE. National costings report for clinical guidance CG147: lower limb peripheral artery disease: diagnosis and management. National Institute for Health and Care Excellence (NICE), 2012.
    1. Lane R, Harwood A, Watson L, et al.. Exercise for intermittent claudication. Cochrane Database Syst Rev 2017; 12: CD000990.
    1. Harwood AE, Smith GE, Cayton T, et al.. A systematic review of the uptake and adherence rates to supervised exercise programs in patients with intermittent Claudication. Ann Vasc Surg 2016; 34: 280–289.
    1. Harwood AE, Pymer S, Ibeggazene S, et al.. Provision of exercise services in patients with peripheral artery disease in the United Kingdom. Vascular. Epub ahead of print 4 August 2021. DOI: 10.1177/17085381211035259.
    1. Barbosa JP, Farah BQ, Chehuen M, et al.. Barriers to physical activity in patients with intermittent claudication. Int J Behav Med 2015; 22: 70–76.
    1. Lin E, Nguyen CH, Thomas SG. Completion and adherence rates to exercise interventions in intermittent claudication: traditional exercise versus alternative exercise – a systematic review. Eur J Prev Cardiol 2019; 26: 1625–1633.
    1. Bulmer AC, Coombes JS. Optimising exercise training in peripheral arterial disease. Sports Med 2004; 34: 983–1003.
    1. Gerhard-Herman MD, Gornik HL, Barrett C, et al.. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. J Am Coll Cardiol 2017; 69: 1465–1508.
    1. Treat-Jacobson D, McDermott MM, Bronas UG, et al.. Optimal exercise programs for patients with peripheral artery disease: a scientific statement from the American Heart Association. Circulation 2019; 139: e10–e33.
    1. Fakhry F, van de Luijtgaarden KM, Bax L, et al.. Supervised walking therapy in patients with intermittent claudication. J Vasc Surg 2012; 56: 1132–1142.
    1. Parmenter BJ, Raymond J, Dinnen P, et al.. A systematic review of randomized controlled trials: walking versus alternative exercise prescription as treatment for intermittent claudication. Atherosclerosis 2011; 218: 1–12.
    1. Mika P, Konik A, Januszek R, et al.. Comparison of two treadmill training programs on walking ability and endothelial function in intermittent claudication. Int J Cardiol 2013; 168: 838–842.
    1. Mika P, Spodaryk K, Cencora A, et al.. Experimental model of pain-free treadmill training in patients with claudication. Am J Phys Med Rehabil 2005; 84: 756–762.
    1. Seed SA, Harwood AE, Sinclair J, et al.. A systematic review of exercise prescription in patients with intermittent claudication: does pain matter? Ann Vasc Surg 2021; 77: 315–323.
    1. American College of Sports Medicine. ACSM’s guidelines for exercise testing and prescription. Philadelphia, PA: Wolters Kluwer, 2018.
    1. Caldow E, Findlow A, Granat M, et al.. Incorporating an exercise rehabilitation programme for people with intermittent claudication into an established cardiac rehabilitation service: a protocol for a pilot study. Contemp Clin Trials Commun 2019; 15: 100389.
    1. Association of Chartered Physiotherapists in Cardiac Rehabilitation. Standards for physical activity and exercise in the cardiovascular population. 3rd ed.: ACPICR, UK, 2015.
    1. Prince SA, Reed JL, Mark AE, et al.. A comparison of accelerometer cut-points among individuals with coronary artery disease. PLoS ONE 2015; 10: e0137759.
    1. Gardner AW, Skinner JS, Cantwell BW, et al.. Progressive vs single-stage treadmill tests for evaluation of claudication. Med Sci Sports Exerc 1991; 23: 402–408.
    1. Birkett ST, Harwood AE, Caldow E, et al.. A systematic review of exercise testing in patients with intermittent claudication: a focus on test standardisation and reporting quality in randomised controlled trials of exercise interventions. PLoS ONE 2021; 16: e0249277.
    1. Morgan MB, Crayford T, Murrin B, et al.. Developing the Vascular Quality of Life Questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia. J Vasc Surg 2001; 33: 679–687.
    1. Regensteiner JG, Steiner JF, Hiatt WR. Exercise training improves functional status in patients with peripheral arterial disease. J Vasc Surg 1996; 23: 104–115.
    1. Cornelis N, Buys R, Fourneau I, et al.. Exploring physical activity behaviour – Needs for and interest in a technology-delivered, home-based exercise programme among patients with intermittent claudication. Vasa 2018; 47: 109–117.
    1. Faul F, Erdfelder E, Buchner A, et al.. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods 2009; 41: 1149–1160.
    1. Harwood AE, Totty JP, Pymer S, et al.. Cardiovascular and musculoskeletal response to supervised exercise in patients with intermittent claudication. J Vasc Surg 2019; 69: 1899–1908.
    1. Wan X, Wang W, Liu J, et al.. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol 2014; 14: 135.
    1. Chan AW, Tetzlaff JM, Altman DG, et al.. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013; 158: 200–207.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006; 3: 77–101.
    1. Moher D, Hopewell S, Schulz KF, et al.. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c869.
    1. Hoffmann TC, Glasziou PP, Boutron I, et al.. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014; 348: g1687.
    1. Ibeggazene S, Pymer S, Birkett ST, et al.. A systematic review of exercise intervention reporting quality and dose in studies of intermittent claudication. Vascular. Epub ahead of print 7 February 2022. DOI: 10.1177/17085381211070700.

Source: PubMed

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