Recruitment to clinical trials of exercise: Challenges in the peripheral arterial disease population

Physiotherapy (United Kingdom)

Volumn 99, Issue 4, 2013, Pages 305-310

  Guidon, M ^a   McGee, H ^a  

^a ROYAL COLLEGE OF SURGEONS IN IRELAND   (Ireland)

Author keywords

Challenges; Exercise; Peripheral arterial disease; Recruitment

Indexed keywords

AGED; AGING; ARTICLE; CARDIOVASCULAR DISEASE; CEREBROVASCULAR DISEASE; COMORBIDITY; CONTROLLED STUDY; FEMALE; HUMAN; IMMOBILIZATION; LEG PAIN; MAJOR CLINICAL STUDY; MALE; PATIENT ATTITUDE; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREADMILL EXERCISE; TREATMENT DURATION;

CHALLENGES; EXERCISE; PERIPHERAL ARTERIAL DISEASE; RECRUITMENT;

AGED; CARDIOVASCULAR DISEASES; CEREBROVASCULAR DISORDERS; CHRONIC DISEASE; COMORBIDITY; EXERCISE THERAPY; FEMALE; HUMANS; MALE; PATIENT SELECTION; PERIPHERAL ARTERIAL DISEASE;

EID: 84887173742     PISSN: 00319406     EISSN: 18731465     Source Type: Journal    
DOI: 10.1016/j.physio.2012.12.010     Document Type: Article

References (30)

1. Lloyd-Jones D., Adams R., Carnethon M., De Simone G., Ferguson T.B., Flegal K., et al. Heart disease and stroke statistics - 2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2009, 119:e21-e181.
2. Hamburg N.M., Balady G.J. Exercise rehabilitation in peripheral artery disease: functional impact and mechanisms of benefits. Circulation 2011, 123:87-97.
3. Golomb B.A., Dang T.T., Criqui M.H. Peripheral arterial disease: morbidity and mortality implications. Circulation 2006, 114:688-699.
4. Norgren L., Hiatt W.R., Dormandy J.A., Nehler M.R., Harris K.A., Fowkes F.G. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007, 45(Suppl.):S5-S67.
5. Tendera M., Aboyans V., Bartelink M.L., Baumgartner I., Clement D., Collet J.P., et al. 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, 32:2851-2906.
6. McDermott M.M., Guralnik J.M., Ferrucci L., Tian L., Liu K., Liao Y., et al. Asymptomatic peripheral arterial disease is associated with more adverse lower extremity characteristics than intermittent claudication. Circulation 2008, 117:2484-2491.
7. Diehm C., Allenberg J.R., Pittrow D., Mahn M., Tepohl G., Haberl R.L., et al. Mortality and vascular morbidity in older adults with asymptomatic versus symptomatic peripheral artery disease. Circulation 2009, 120:2053-2061.
8. Watson L., Ellis B., Leng G.C. Exercise for intermittent claudication. Cochrane Database Syst Rev 2008, 4:CD000990.
9. Bendermacher B.L., Willigendael E.M., Teijink J.A., Prins M.H. Supervised exercise therapy versus non-supervised exercise therapy for intermittent claudication. Cochrane Database Syst Rev 2006, 2:CD005263.
10. Peters-Lawrence M.H., Bell M.C., Hsu L.L., Osunkwo I., Seaman P., Blackwood M., et al. Clinical trial implementation and recruitment: lessons learned from the early closure of a randomized clinical trial. Contemp Clin Trials 2012, 33:291-297.
11. Treweek S., Mitchell E., Pitkethly M., Cook J., Kjeldstrom M., Taskila T., et al. Strategies to improve recruitment to randomised controlled trials. Cochrane Database Syst Rev 2010, 1:MR000013.
12. Rothwell P.M. External validity of randomised controlled trials: 'to whom do the results of this trial apply?'. Lancet 2005, 365:82-93.
13. Dishman R.K., Ickes W. Self-motivation and adherence to therapeutic exercise. J Behav Med 1981, 4:421-438.
14. American Association of Cardiovascular and Pulmonary Rehabilitation Guidelines for cardiac rehabilitation and secondary prevention programs 2004, Human Kinetics, Champaign, IL. 4th ed.
15. Spronk S., Dolman W., Boelhouwer R.U., Veen H.F., den Hoed P.T. The vascular nurse in practice: results of prescribed exercise training in patients with intermittent claudication. J Vasc Nurs 2003, 21:141-144.
16. Norgren L., Hiatt W.R., Dormandy J.A., Nehler M.R., Harris K.A., Fowkes F.G., et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). Eur J Vasc Endovasc Surg 2007, 33(Suppl. 1):S1-S75.
17. Hobbs S.D., Bradbury A.W. The Exercise versus Angioplasty in Claudication Trial (EXACT): reasons for recruitment failure and the implications for research into and treatment of intermittent claudication. J Vasc Surg 2006, 44:432-433.
18. Lloyd-Williams F., Mair F., Shiels C., Hanratty B., Goldstein P., Beaton S., et al. Why are patients in clinical trials of heart failure not like those we see in everyday practice?. J Clin Epidemiol 2003, 56:1157-1162.
19. Evenson K.R., Fleury J. Barriers to outpatient cardiac rehabilitation participation and adherence. J Cardiopulm Rehabil 2000, 20:241-246.
20. Galea M., Bray S. Predicting walking intentions and exercise in individuals with intermittent claudication: an application of the theory of planned behavior. Rehabil Psychol 2006, 51:299-305.
21. Ridda I., MacIntyre C.R., Lindley R.I., Tan T.C. Difficulties in recruiting older people in clinical trials: an examination of barriers and solutions. Vaccine 2010, 28:901-906.
22. Gillies K., Entwistle V.A. Supporting positive experiences and sustained participation in clinical trials: looking beyond information provision. J Med Ethics 2012, 38:751-756.
23. Chang B.H., Hendricks A.M., Slawsky M.T., Locastro J.S. Patient recruitment to a randomized clinical trial of behavioral therapy for chronic heart failure. BMC Med Res Methodol 2004, 4:8.
24. Mazari F.A., Carradice D., Rahman M.N., Khan J.A., Mockford K., Mehta T., et al. An analysis of relationship between quality of life indices and clinical improvement following intervention in patients with intermittent claudication due to femoropopliteal disease. J Vasc Surg 2010, 52:77-84.
25. Torgerson D.J., Sibbald B. Understanding controlled trials. What is a patient preference trial?. BMJ 1998, 316:360.
26. Olin J.W., Sealove B.A. Peripheral artery disease: current insight into the disease and its diagnosis and management. Mayo Clinic Proc 2010, 85:678-692.
27. Galea M.N., Bray S.R., Ginis K.A. Barriers and facilitators for walking in individuals with intermittent claudication. J Aging Phys Act 2008, 16:69-83.
28. Jeger R.V., Rickenbacher P., Pfisterer M.E., Hoffmann A. Outpatient rehabilitation in patients with coronary artery and peripheral arterial occlusive disease. Arch Phys Med Rehabil 2008, 89:618-621.
29. Hirsch A.T., Haskal Z.J., Hertzer N.R., Bakal C.W., Creager M.A., Halperin J.L., et al. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): executive summary a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease) endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol 2006, 47:1239-1312.
30. Gardner A.W., Katzel L.I., Sorkin J.D., Killewich L.A., Ryan A., Flinn W.R., et al. Improved functional outcomes following exercise rehabilitation in patients with intermittent claudication. J Gerontol A Biol Sci Med Sci 2000, 55:M570-M577.